药物信息协会(dia)第五届中国年会 - eventdove.com · 美国fda 同仁会国际部 ......
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药物信息协会(DIA)第五届中国年会患者关爱与药物安全
5th DIA China Annual MeetingPatient Safety - A Sustained Focus
from Scientific Ideas to Innovative Medicines
中国 · 北京国际会议中心
Beijing International Convention Center, China
2013年5月12日 —— 会前专题研讨会 2013年5月13-15日 —— 会议、展览和壁报
May 12, 2013 - Preconference WorkshopsMay 13-15, 2013 - Conference, Exhibition and Posters
PRELIMINARY PROGRAM大 会 日 程 ( 2 0 1 3 / 0 5 / 0 2 )
w w w . d i a c h i n a . o r g
合办单位：
中国医药国际交流中心
程刚
国家食品药品监督管理总局药品评价中
心，国家药品不良反应监测中心主任助理
Gang CHENG
Assistant Director, National Center for ADR Monitor, Center for Drug Reevaluation, CFDA, China
Florence houn 医学博士，公共卫生硕士
美国FDA同仁会国际部联席主席
前美国FDA药品审评及研究中心药品评价三
处处长
美国塞尔基因公司法规政策与战略副总裁
Florence HOUN, MD, MPH, FACPCo-Chair of FDA Alumni Association International Network (FDAAA); Former Director, Office of Drug Evaluation III, US FDA/CDER; Vice President, Regu-latory Policy and Strategy, Celgene, USA
李庆红
辉瑞医疗质量保证部亚洲地区负责人
Helen LI, MDEmerging Market QA Asia Lead, Pfizer Medical Quality Assurance, China
刘宗范
默沙东研发(中国)有限公司全球临床数据管
理中心亚太区总监
Joanne LIU, MDDirector, Global Clinical Data Management & Standard, MSD R&D (China) Center, China
邓亚中 工商管理硕士
科文斯(中国)临床数据分析与报告
负责人
Yazhong DENG, MBAHead of Clinical Data Analysis and Report-ing Organization (CDARO), Covance, China
蒋皓媛 医学博士
江苏恒瑞制药有限公司医学执行总监
Helen JIANG, MD, PhDExecutive Medical Director, Jiangsu Hengrui Medicine Co. Ltd., China
刘川 博士
医药数据解决方案公司大中华地区发展
总监
Daniel LIU, PhDDirector, China Development, Medidata Solutions Worldwide, China
任毅 博士
南京摩迪生物医药研发有限公司总经理
Yi REN, PhDGeneral Manager, Nanjing Medichem Ltd. China
陈之键 医学博士, 工商管理硕士
阿斯利康(中国)
全球药物研发 中国区副总裁兼负责人
George CHEN, MD, MBAVice President and Head of Global Medi-cine Development of China, AstraZeneca Global Medicine Development, China
黄彬
阿斯利康(中国)药物研发部药政事务和品
牌仿制药开发执行总监
Laurence HUANGExecutive Director, Regulatory Affairs and Branded Generics Development, RD Department, AstraZeneca, China
梁冰
辉瑞(中国)研究开发有限公司安全监测及风
险管理/全球安全战略部总监,力普妥全球安
全风险负责人
Vera LIANG, MDDirector and Global Safety Risk Lead, Safety Surveillance and Risk Management, Pfizer (China) R&D Co. Ltd., China
曲鹏 博士
辉瑞(中国)研究开发有限公司统计部
高级总监
Roger QU, PhDHead of Clinical Statistics, Pfizer China R&D Center, China
大会组织委会 PrograM coMMiTTee
桂敏 博士
百时美施贵宝全球注册科学部亚太区
CMC，中国CMC和运营部总监
Min GUI, PhD Director, CMC Asia Pacific, China CMC & Operation of the Global Regulatory Sci-ence, Bristol-Myers Squibb (BMS), China
刘佳
爱恩希(北京)医疗科技有限公司 北亚及中
国区总经理
Jessica LIU, MDGeneral Manager, China and North Asia, INC (Beijing) Medical Technology Co. Ltd., China
李宁 医学博士
赛诺菲药学与医学政策亚洲区副总裁
Ning LI, MD, PhDVice President, Regulatory and Medical Policy, Asia Region, Sanofi, China
史力 博士
上海泽润生物科技有限公司首席执行官
Li SHI, PhDCEO, Shanghai Zerun Biotechnology Co. Ltd., China
王捷 博士
江苏省人民医院教授
江苏省临床医学研究院常务副院长
Jie WANG, MD, PhDExecutive Vice President, Academy of Clin-ical Research and Translational Medicine, Jiangsu Province Hospital, China
张迅 博士
葛兰素史克(上海)医药研发有限公司总裁
Xun ZHANG, PhDVice President, Head of Global Natural Product Business Unit, GSK R&D, China
徐宁 医学博士,工商管理硕士
科文斯公司副总裁，中国临床研究事业部负责人
Ning XU, MD, MBAVice President, Head of Clinical Develop-ment Service, Covance, China
许俊才
上海医药临床研究中心高级副总裁
Jack XU, MDSenior Vice President, Shanghai Clinical Research Center, China
王春燕
圣犹达医疗用品(香港)有限公司亚太区临床
研究总监
Spring WANG, MDRegional Clinical Director, St. Jude Medical, Asia Pacific, Hong Kong, China
袁维颖 博士
强生药物研发中国生物统计和统计程序部
门总监
Weiying YUAN, PhDSite Head of Biostatistics and Program-ming, China Pharmaceutical Research and Development, Johnson & Johnson, China
大会组织委会 PrograM coMMiTTee
王武保 博士
默沙东研发(中国)有限公司
生物统计与研究决策科学部-亚太区执行总
监
William WANG, PhDSite Head and Executive Director, Biosta-tistics and Research Decision Sciences - Asia Pacific (BARDS-AP), Merck Research Laboratories / MSD R&D (China) Co. Ltd., China
徐莉 医学博士，工商管理硕士
美国辉瑞公司肿瘤业务部， 肿瘤中国策略规划、贯彻和全球运作部副总裁
Li XU, MD, MSD, MBAVice President, Oncology China Strategy, Implementation, and Oncology Opera-tions, Oncology Business Unit, Pfizer Inc., China
Thank YoU To oUr PrograM coMMiTTe For deveLoPing a greaT PrograM!
吴 博士第一三共(中国)投资有限公司医药开发总
部总经理
Yan WU, MDGeneral Manager, Division of Medical and Drug Development, Daiich Sankyo (China)Holding Co. Ltd., China
闫小军 工商管理硕士
拜耳医药保健有限公司全球注册战略发展
特药负责人
Wendy YAN, MD, MBAGlobal Regulatory Strategist, Asia Global R&D Center, Bayer Healthcare Co. Ltd., China
孙稚平 博士
默沙东研发(中国)有限公司生物统计和研
究决策科学部，亚太区后期研发统计组
资深统计学家
Linda SUN, PhDSenior Statistician, Late Development Sta-tistics, Biostatistics and Research Decision Sciences - Asia Pacific, MSD R&D (China) Co. Ltd., China
大会顾问委员会 adviSorY coMMiTTee
陈恒德 医学博士
台湾生技整合育成中心医务长
Herng-Der CHERN, MD, PhDChief Medical Director, Supra Integration and Incubation Center, Taiwan
杨青 博士
阿斯利康全球研发亚洲及新兴市场研发总裁
Steve YANG, PhDVice President, Head of R&D, Asia & Emerging Markets, AstraZeneca Global R&D, China
李自力 医学博士，公共卫生硕士
美国FDA同仁会国际部联席主席；前美国
FDA新药临床审评组组长；美国默克公司(
默沙东)新兴市场注册策略执行总监
Zili LI, MD, MPHCo-Chair of FDA Alumni Association Interna-tional Network; Former Medical Team leader, US FDA/CDER; Executive Director and Head of Emerging Market Regulatory Strategy and Liaison, Merck/MSD, USA
董瑞平 博士
默沙东实验室新兴市场高级副总裁
Ruiping DONG, PhDSenior Vice President, Emerging Markets, MSD Laboratory, China
张连山 博士
江苏恒瑞医药股份有限公司副总经理兼全
球研发总裁
Lianshan ZHANG, PhDPresident, Global R&D, Jiangsu Hengrui Medicine Co. Ltd., China
施一公 教授，博士
清华大学生命科学学院院长
Yigong SHI, Professor, PhDDean, School of Life Sciences, Tsinghua University, China
毕红钢 博士
科文斯医药研发(北京)有限公司副总裁
中国区总经理
Honggang BI, PhDCorporate Vice President, General Man-ager China, Covance, China
冯毅
国家食品药品监督管理总局药品审评中心
业务管理部部长/中心主任助理
Yi FENGAssistant Centre Director for Pharmaceu-ticals, Office Director of Office of Man-agement and Communication, Center For Drug Evaluation, CFDA, China
宋瑞霖
中国医药工业科研开发促进会执行会长
Ruilin SONGExecutive Chair, China's Pharmaceutical Industry Research and Development Pro-motion Association, China
蔡学钧 博士
上海罗氏制药有限公司医学部总监
James CAI, PhDMedical Director, Medical Affairs, Shanghai Roche Pharmaceuticals Ltd., China
江宁军 医学博士
赛诺菲全球研发副总裁亚太区研发总裁
Frank JIANG, MD, PhDVice President, Global R&D and Head of Asia & Pacific R&D, Sanofi, China
苏岭 博士
DIA全球理事会主席
盛德国际律师事务所生命科学战略顾问
Ling SU, PhDPresident, DIA Board of DirectorsStrategic Advisor, Life Sciences, Sidley Austin LLP, China
ning XU (Chair)Laurence hUang (ViCe Chair)
Yan caiLili caohannah chengeorge chenPaul daialicia dUYanhua gonghaiyan Lining Lihelen LiShuting Livera LiangJessica LiUJoanne LiUdonglei MaoYi renLi ShiJie wangJingsong wangPeng wangwilliam wangZhiang wUJack XUwendy Yanrachel YangSteve YangTony Zhang
中国区顾问委员会
Ad
viso
ry C
ou
nci
l of
Ch
ina
(AC
C)
中国区顾问委员会(ACC)由企业、学术界、医疗机构和政府部门的专家组
成。委员会为DIA中国区开展学术交流活动、建立战略伙伴、发展会员及提
供战略指导和支持 。
The Advisory Council of China (ACC) consists of regional industry and aca-demic leaders, regulators and researchers who are responsible for creating a sense of community among those who support the DIA vision to provide a global forum for knowledge exchange that fosters innovation to raise the level of health and well-being worldwide.
徐宁 (主席)
黄彬(副主席)
蔡琰
曹莉莉
陈华
陈之键
戴欣
杜英华
宫岩华
李海燕
李宁
李庆红
李树婷
梁冰
刘佳
刘宗范
毛冬蕾
任毅
史力
王捷
王劲松
王鹏
王武保
武志昂
许俊才
闫小军
杨佩蓉
杨青
张彦涛
dia中国区顾问委员会
中国区顾问委员会成员：
Members of advisory council of china (acc) :
DIA中国区顾问委员会
主席
ADVISORY COUNCIL OF CHINA (ACC)CHAIR
徐宁 医学博士,工商管理硕士
科文斯公司副总裁
中国临床研究事业部负责人
Ning XU, MD, MBAVice President, Head of Clinical Development Service, Covance, China
黄彬
阿斯利康(中国)药物研发部药政事
务和品牌仿制药开发执行总监
Laurence HUANGExecutive Director, Regulatory Affairs and Branded Generics Development, RD Department, AstraZeneca, China
Advisory Council of China (ACC)
DIA中国区顾问委员会
副主席
ADVISORY COUNCIL OF CHINA (ACC)
VICE CHAIR
20
DIA学术沙龙交流活动
分享成功经验、 联络业界同行、 交流专业知识。
5月15日 | 12:00-13:30 二层，一号厅
学术壁报展
大会展厅设有学术壁报。壁报展与会议同时举行。
5月13-15日 | 8:30-17:30
DIA中国第五届年会汇聚了来自中外药品监管机构、制药企业、医疗器械行业及科研院所的专业人士。这是业内同行交流互动、搭建职业关系网络的良好机会。
颁奖典礼
DIA杰出贡献奖于年会开幕式颁发。
5月13日 星期一 | 13:30 (二层，一号厅)
壁报展抽奖活动
壁报展示者均能参加抽奖活动。活动将于5月15日星期三上午10:00茶歇期间在展厅举行。请别错过获奖机会！
• 一等奖－DIA活动全价优惠券 凭优惠券可参加除年会以外任何一次中国DIA会议或培训，免注册费。
• 二等奖－DIA活动半价优惠券 凭优惠券可享受除年会以外任何一次中国DIA会议或培训的半价优惠。
• 三等奖－免费DIA会员资格(1年) 赠送一年DIA会员资格，此期间享受所有DIA会员特惠，包括中国和全球DIA活动的注册优惠。
互动交流
奖项
茶歇(展厅)
与同行交流感想，分享信息和经验。早、午茶歇安排在展厅。
5月12日 星期日 | 10:00-10:30, 15:00-15:30 5月13日 星期一 | 15:00-15:305月14日 星期二 | 10:00-10:30, 15:00-15:305月15日 星期三 | 10:00-10:30, 15:00-15:30
午餐
5月12日 星期日 | 12:00-13:00 二层，二号厅5月14日 星期二 | 12:00-13:30 二层，一号厅5月15日 星期三 | 12:00-13:30 二层，一号厅
欢迎招待会-中国之夜：dia中国五周年庆典
招待会包括传统文化表演和抽奖活动并提供特色餐点。
5月13日 星期一 | 17:30-19:30 展厅和二层，二号厅
讲者嘉宾招待酒会
5月14日 星期二 | 17:30-19:30 二层，二号厅
21
联系人
报名注册
谢飞
Email: [email protected]: +86 10 6260 2241
讲者支持
宁尔宁
Email: [email protected]: +86 10 6260 2248
会前专题研讨
费澍
Email: [email protected]: +86 10 6260 2239
赵英
Email: [email protected]: +86 10 6260 2242
壁报
费澍
Email: [email protected]: +86 10 6260 2239
展商联络
徐迎宾
Email: [email protected]: +86 10 5923 1096
contActs
regiSTraTionFei XIE
Email: [email protected]: +86 10 6260 2241
SPeaker SUPPorTErning NING
Email: [email protected]: +86 10 6260 2248
PreconFerence workShoPShu FEI
Email: [email protected]
TEL: +86 10 6260 2239
Ying ZHAO
Email: [email protected]: +86 10 6260 2242
PoSTerSShu FEI
Email: [email protected]: +86 10 6260 2239
eXhibiTSJean XU
Email: [email protected]: +86 10 5923 1096
The 5th DIA China Annual Meeting attracts professionals from global regulatory agencies, pharmaceutical/biopharmaceutical and medical device industries, and academic institutes with key networking opportunities.
Tea breakSMeet with colleagues and network at the Exhibition Hall.
Sunday, May 12 | 10:00-10:30, 15:00-15:30 Tuesday, May 14 | 10:00-10:30, 15:00-15:30Monday, May 13 | 15:00-15:30 Wednesday, May 15| 10:00-10:30, 15:00-15:30
LUnch hoUrSEnjoy extended lunch hours and visit more than 60 exhibits at the Exhibition Hall.
Sunday, May 12 | 12:00-13:00 2nd Floor, Conference Hall 2Tuesday, May 14 | 12:00-13:30 2nd Floor, Conference Hall 1Wednesday, May 15 | 12:00-13:30 2nd Floor, Conference Hall 1
dia weLcoMe recePTion- china nighT: 5Th anniverSarY ceLebraTion
Monday, May 13 | 17:30-19:30 1st Floor, Exhibition Hall and 2nd Floor, Conference Hall 2
NEtWorKIng
aWarD ceremony
award cereMonYDIA China Volunteer Awards will be presented during the opening plenary session.
Monday, May 13 | 13:30 2nd Floor, Conference Hall 1
PriZeS For PoSTer PreSenTerSAll poster presenters have an opportunity to the win prizes. The lucky draw will take place during the morning tea break on Wednesday, May 15 at 10:00. Don’t miss the chance to win the 3 prizes:
• 1st Prize – Full DIA Event Coupon With this coupon you can get a complimentary full pass for any one of the DIA China events except for the annual meeting.
• 2nd Prize – 50% DIA Event Coupon With this coupon, you can receive a 50% discount for any one of the DIA offerings in China except for the annual meeting.
• 3rd Prize – DIA 1-Year Membership Join the DIA community and enjoy one-year complimentary DIA E-membership benefits for free. The E-membership also offers discount on a variety of regious DIA educational offerings such as conferences, workshops and trainings, held in China and in other countries.
Wednesday, May 15 | 10:00
DIA CHINA 2013 Annual Meeting | Beijing
SPeaker & viP recePTion
Tuesday, May 14 | 17:30-19:30 2nd Floor, Conference Hall 2
dia coMMUniTYShare Best Practices, Network with Professional Colleagues and Exchange Knowledge.
Wednesday, May 15 | 12:00-13:30 2nd Floor, Conference Hall 1
ProFeSSionaL / STUdenT PoSTer PreSenTaTionJoin us at the Exhibition Hall as we showcase posters by professionals and students. Poster presenters will share their research results in various topics. The posters show will be available during the Annual Meeting.
May 13-15 | 8:30-17:30
22
老北京小吃
北京传统小吃是京城文化的“活化石”。它们的制作方式和食用方式蕴含着老北京特有的生活哲理和审美意趣。京城各处的隆福寺小吃和护国寺小吃店皆有供应各式北京小吃。
豆汁
提起北京小吃，首先会想起豆汁。豆汁实际上是制作绿豆淀粉或粉丝的下脚料，具有色泽灰绿，豆汁浓醇，味酸且微甜的特色。正因这独特的风味，很多人第一次品尝都不太习惯。老北京人对豆汁情有独钟，并把喝豆汁当成是一种享受，原因在于它营养丰富，并能开胃去燥。
豌豆黄
豌豆黄是典型的北京春令食品，原为民间小吃，后传入宫廷。豌豆黄颜色浅黄，细腻凉甜，入口即化，且甜而不腻，是夏季消暑佳品。
驴打滚
"驴打滚"是用黄米夹馅而成的长卷，食用时将长卷切块、滚上豆面，过程颇似驴儿打滚，因此得名。做好的“驴打滚”豆香馅甜，入口绵软，别具一番风味。
艾窝窝
艾窝窝是老北京清真风味小吃。艾窝窝是用蒸过的糯米包入甜馅，再裹上粉面制成。曾有诗云“白黏江米入蒸锅，什锦馅儿粉面搓。浑似汤圆不待煮，清真唤作艾窝窝”。其特点是色泽洁白如霜，质地细腻柔韧，馅心松散甜香。
会议中心
北京景点介绍
北京天安门广场与人民英雄纪念碑
首都北京的象征。它坐落在中华人民共和国首都北京的市中心的东长安街上，故宫南侧。周围有前门、毛主席纪念堂、人民英雄纪念碑、天安门城楼、故宫、中国革命历史博物馆、人民大会堂、劳动人民文化宫、中山公园、国家大剧院等景点。乘1, 4, 20, 52, 57, 101, 103, 109路公共汽车、地铁1号线天安门东、天
安门西，2号线前门站均可到达。
故宫博物院
世界上规模最大，保存最完整的帝王宫殿。它坐落在中华人民共和国首都北京的市中心的东长安街上，天安门广场以北。周围有天安门广场、劳动人民文化宫、中山公园、景山公园、北海公园及中南海等景点。 乘1, 4, 20, 52, 57, 101, 103, 109路公共汽车、地铁1号线天安门东、天安门西，2号线前门站均可到达。
八达岭长城
最为雄伟的长城。坐落在北京延庆县。周围有熊乐园等新建的游乐设施。北京站乘游1路游4路、游5路、或
者宣武门乘游2路支线。
颐和园
保存最好的皇家园林。坐落在北京市区西北的海淀区新建宫门路19号。距圆明园遗址公园较近。乘301, 303, 330, 332, 333, 346, 362, 375, 384, 394, 716, 718, 801, 817, 904路公共汽车均可到达。
北海公园
建园最早的皇家园林。位于西城区文津街1号(故宫北)。周围有故宫、景山公园及中南海。乘5, 11, 13, 42, 101, 103, 107, 109, 111, 118路公共汽车均可到达。
天坛
明清两代帝王祭天的地方。位于北京东城区。出天坛西门走一站地可参观北京自然博物馆。乘6, 15, 17, 20, 35, 36, 39, 105, 120, 103, 106, 110, 116路公共汽车均可到达, 由南门或北门进入参观主要景点。
地理位置
北京国际会议中心坐落于繁华的亚运村地区，北四环路与京城中轴线交汇处，紧邻国家体育馆鸟巢和水立方。具体地址为：北京市朝阳区北辰东路8号。
北京首都国际机场 — 北京国际会议中心(BICC)
出租车
从北京首都国际机场到北京国际会议中心乘坐出租车起步价为10元(3公里)，此后以2元／公里计价。从机场到会场的车程约20公里。
请参照航站楼内指示牌。机场出租车调度管理电话：+86-10-64558892。
公共交通
机场巴士至北京市区约50分钟车程。乘坐机场巴士5号线(中关村专线)至“亚运村(安慧桥)”下车，向西步
行200米即到。
北京国际会议中心周边地铁及公交
公交车
740路、840路、753路、696路、386路、656路、944路 — 亚运村站；
758路、358路、108路、850路、803路、858路、328路、387路、694路、849路等 — 安慧桥北站;
地铁
乘地铁五号线到惠新西街北口站下，改乘753路或696路公交车至亚运村站。
停车
北京国际会议中心约有100个地上停车位，旁边的五洲皇冠酒店共有地上和地下140个停车位，停车收费人民币5元/小时。
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enJoY The ciTY'S SighTSBEST OF BEIJING provides a variety of tours that showcase the most exciting and unusual sites the city has to offer. Mark the most of your time in Beijing by taking advantage of one of the oppportunities listed below.
geTTing To beiJing inTernaTionaL convenTion cenTer (bicc)LOCATIONThe Beijing International Convention Center is located at No.8 Beichen East Road, Chaoyang District, within the magnificent Asian Games Village. The venue is right next to the famous Beijing National Stadium “Bird’s Nest” and the Aquatic Center “Water Cube”.
FROM AIRPORT TO BICC By Taxi Taxis are available at the taxi stop outside each Terminal at the Beijing International Airport. Please refer to the signs for Taxi Stop. Airport Taxi Management Number: +86-10-6454-1100.
Taxis are charged with a base rate of 10 RMB for the first 3 kilometers, and an additional 2 RMB/km rate thereafter. A one-way taxi trip from the airport to BICC is about 20km. Note: It is suggested that you bring the printed hotel address in Chinese, together with the hotel phone number for reference purpose.
PARkING The Beijing International Convention Center (BICC) provides 100 parking spaces, along with the 140 ground and underground parking spaces offered by the adjacent Crowne Plaza Hotel, at a rate of ¥5 per hour.
TradiTionaL beiJing SnackS
Traditional Beijing Snacks are living fossils of local life and flavors. Snack restaurants, such as Longfusi and Huguosi snack counters, can be easily found in downtown Beijing.
MUng bean MiLk (doU Zhi)
Probably the most famous Beijing snack, mung bean milk is actually the fluid remnants of the mung bean noodle making process. It tastes mostly sour with a tinge of sweetness, and has a peculiar odor—definitely an acquired taste. Local Beijingers love the mung bean milk, because it is nutritious and help whet the appetite.
Pea FLoUr cake(wan doU hUang)Made with white peas, pea flour cake is a favorable springtime snack, and was very popular among members of the imperial court. A pea flour cake has a unique taste of loose consistency. It is refreshing, yet not too sweet.
roLLing donkeY (Lv da gUn)Rolling donkey refers to a kind of cake made with steamed sticky rice, filled with red pea, and then drizzled over with fried bean flour. After being cut into blocks, the cake is rolled in soybean flour, looking like a donkey rolling on the ground raising dust, hence the name.
STickY rice baLLS (ai wo wo)As a court snack during the Yuan Dynasty (1206~1368), sticky rice is an opaque, smooth-looking, chewy ball of sweetness. It is made of glutinous rice or millet, and stuffed with sweet filling and dusted with rice flour. The usual fillings are sesame and white sugar, pea flour and red been paste.
beiJing TiananMen SqUare and The MonUMenT To The PeoPLe'S heroeS
Located at the center of Beijing is the Tiananmen Square, where you can visit Tiananmen Tower, Monument to the People's Heroes, Great Hall of the People, Mao Zedong Memorial Hall and attend a national flag raising ceremony. The granite Monument to the People's Heroes is right at the center of the square. Built in 1952, it is the largest monument in China's history. Ten marble relief sculptures around it showcase the development of Chinese modern history.
The Forbidden ciTYNorth to the Tiananmen Square lies the Forbidden City. For almost 500 years, it served as the home of emperors and their households, as well as the ceremonial and political center of Chinese government. The palace complex exemplifies traditional Chinese palatial architecture, and was declared a World Heritage Site as the largest collection of preserved ancient wooden structures in the world.
The badaLing greaT waLLBuilt during the Ming Dynasty (1368-1644), the Badaling section is the most magnificent part of the Great Wall. The unique geographical advantage made it an unconquerable military stronghold of ancient China. The Wall features a dragon winding its way along the mountain ranges.
The SUMMer PaLaceBeing one of the best-preserved imperial gardens, the Summer Palace is a masterpiece of Chinese landscape design. The natural landscape of hills and open water is combined with artificial features such as pavilions, halls, palaces, temples and bridges to form a harmonious ensemble of outstanding aesthetic value. It is a popular tourist destination but also serves as a recreational park.
beihai ParkWith the Forbidden City to its east, Beihai Park is one of the earliest and largest ancient imperial gardens in China located in the city center. It is not only a classic combination of the grandiosity of the northern gardens and the refinement of the southern gardens in China, but also a perfect integration of magnificent imperial palaces and solemn religious architectures.
The TeMPLe oF heavenSituated in the southeastern of Beijing, it is a complex of religious buildings that was visited by Chinese emperors for annual ceremonies of prayer to Heaven for good harvest. The symbolic layout and design of the Temple of Heaven simply and graphically illustrates the great importance of cosmogony in the evolution of Chinese civilization.
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NNNNNNNN
LEGENDLEGEND
0 100 200Meters
Subwayloop line
SidewayLake / River
HighwaysRoads
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3
2
5
4
6
7
8
9
Huizhong Rd
Xiaoying West Rd
Xiaoying Rd
Anli R
d
Beichen R
d
BeichenEast R
d
N.4th Ring Rd EN.4th Ring Rd E
Anyuan Rd
Huizhong Rd
Xiaoying West Rd
Xiaoying Rd
Anli R
d
Beichen R
d
BeichenEast R
d
N.4th Ring Rd E
N.4th Ring Rd EN.4th Ring Rd E N.4th Ring Rd E
Anyuan Rd
酒店信息
编号 酒店 距主会场距离 网址 联系方式
1
2
3
4
5
6
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8
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北京国际会议中心北辰五洲大酒店
北京五洲皇冠假日酒店
北京汇源酒店公寓贵宾楼
北京国玉大酒店
北京汇源酒店公寓
北京亚运村宾馆
北京汉庭快捷酒店(亚运村店)
北京桔子连锁酒店 (亚运村店)
速8酒店北京鸟巢店
电话：+86-10-8498 0105 传真：+86-10-8498 7716
电话：+86-10-6481 7136 +86-10-6481 7137
电话：+86-10-6499 1166
电话：+86-10-5979 2331 +86-10-5166 2121
电话：+86-10-6499 1166
电话：+86-10-6499 3088
电话：+86-10-6491 6699
电话：+86-10-6495 3131 或 400 819 0099
电话：+86-10-5140 2266
0.2公里
0.3 公里
0.6 公里
0.6 公里
0.6 公里
0.4公里
0.96 公里
0.98公里
1.36 公里
https://www.bcghotel.com/jiudian/yuding/huiyi.asp?laiyuan (登录密码：diachina)
http://www.eventdove.com/resource/20130320/1531_20130320095906311.pdf
http://www.huiyuangongyu.com.cn
http://www.guoyuhotel.com/
http://www.huiyuangongyu.com.cn
http://www.huiyuangongyu.com.cn
http://www.htinns.com/
http://www.orangehotel.com.cn/beijing/yayuncun.html
http://www.super8.com.cn
Airport首都国际机场
北京国际会展中心
北京五洲大酒店
Airport Expressway
Forbidden City
Tian An Men Square
Temple of Heaven
Chang’an Ave
2nd Ring Road
3rd Ring Road
4th Ring Road
5th Ring Road
Expressway to The Great Wall
BEIJING INTERNATIONAL CONVENTION CENTER
BEIJING INTERNATIONAL GRAND HOTEL
Summer Palace
机场高速
八达岭高速
北五环
北四环
北三环
北二环
长安街
天安门
天坛
故宫
颐和园
25hotel lIst
map# hotel Distance to convention center hotel Website hotel phone number
1
2
3
4
5
6
7
8
9
north star continental grand hotel - main conference hotel
Crowne Plaza Beijing Parkview Wuzhou
Beijing Huiyuan Service Apart-ments VIP House
National Jade Hotel
Beijing Huiyuan Service Apart-ment Hotel
Beijing Ya Yun Cun Hotel
HANTING INNS & HOTELS (Yayuncun)
Orange Hotel (Yayuncun)
Super 8 Hotels (Bird Nest)
+86-10-8498 0105
+86-10-6481 7136 +86-10-6481 7137
+86-10-6499 1166
+86-10-5979 2331 +86-10-5166 2121
+86-10-6499 1166
+86-10-6499 3088
+86-10-6491 6699
+86-10-6495 3131
+86-10-5140 2266
0.2 Km
0.3 Km
0.6 Km
0.6 Km
0.6 Km
0.4 Km
0.96 Km
0.98 Km
1.36 Km
https://www.bcghotel.com/jiudian/yuding/huiyi.asp?laiyuan (password: diachina)
http://www.eventdove.com/resource/20130320/1531_20130320095906311.pdf
http://www.huiyuangongyu.com.cn
http://www.guoyuhotel.com/
http://www.huiyuangongyu.com.cn
http://www.huiyuangongyu.com.cn
http://www.htinns.com/
http://www.orangehotel.com.cn/beijing/yayuncun.html
http://www.super8.com.cn
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杂技表演：柔术 滚灯acrobatic Show : contortion
Contortion is among the family of traditional Chinese acrobatics. It is an unusual form of physical performance, which involves the dramatic bending, and flexing of human body. In general, contortionists have extraordinary natural flexibility, which is then enhanced through gymnastic training.
川剧: 变脸Sichuan Face change Sichuan Opera is well known for its heritage of traditional repertoire and superb performing skills. The Face Change technique in Sichuan Opera features stunning visual effects, and outstanding performing arts explicating the characters’ inner world in a romanticized way. Face Change consists of three types - hand face, blowing face, and push face.
京剧: 贵妃醉酒 beijing opera: The drunken beauty
Dating back to the 3rd century, Chinese opera is a popular art form of drama and musical theatre in China. There are numerous regional branches of Chinese opera, among which the Beijing opera is the most prestigious. Beijing Opera combines music, acrobatic dance, and spectacular costumes to tell stories from Chinese history and folklore. The traditional features of the makeup and elaborate costumes immediately identify the characters to a knowing audience.
魔术: 快乐变、变、变Magic Show
Making something disappear is not enough: the hardest part is where you bring it back. Join us in the miraculous show and watch how the magician takes the ordinary something and makes it into something extraordinary.
欢迎招待会-中国之夜：dia中国五周年庆典
招待会包括传统文化表演、抽奖活动及特色餐点。
5月13日 星期一 | 17:30-19:30
药物信息协会(DIA)第五届中国年会官方媒体合作伙伴
5th DIA China Annual Meeting Official Media Partners
www.pharmachinaonline.com
27
company WhIte paper shoWcaseThis year, the White Paper Showcase organized by three companies will share their experience, expertise and practices on drug safety and techonology for innovation.
quintiles 13:30 - 15:00 (3rd floor, 308)TecTonic TranSForMaTionS: The FUTUre oF bioPharMa-ceUTicaLS in aSia
amar kUrerShi, Md, FrcPcChief Medical Officer and Head of Drug Development, Quintiles Asia, Singapore
Ling ZhenVice President and General Manager, Quintiles, Greater China
Proswell Medical company 15:30 - 17:30 (3rd floor, 308)
PaTienT SaFeTY and ProacTive riSk ManageMenT in cLinicaL TriaL
Establish a Post Marketing Safety System and Standard Procedure to Ensure Product Safety and Proactively Manage Risk
• A comprehensive “End-to-End” safety surveillance system• Highly specified safety operational and pharmacovigilance processes• Special designed pharmacovigilance programs support in global post
marketing risk benefit assessment
Sean Zhao, Md, PhdVice President, Global Safety, Amylin Pharmaceuticals, Inc. U.S. Head of Pharmacoepidemiology (PV-Epi) Amgen Global Safety Surveillance Process OwnerChairperson of Amgen Safety Policy Committee
Subjects Safety in Phase I Clinical Trial
• Category of safety issues• Unpredictable safety issues• Case analysis about unpredictable safety issues
bei hU, PhdChief Physician, Clinical Pharmacology Research Center, Peking Union Medical College Hospital, China.
c3i13:30 - 15:00 (3rd floor, 308)
advance cLinicaL TriaLS TechnoLogY: beST PracTiceS in dePLoYing gLobaL word-cLaSS SUPPorT For ecLinicaL aPPLicaTionS
Discover how site-centric service desk support can provide a comprehensive single point of contact for all technology needs of global clinical sites, ensure accurate data collection and reduce the time spent by the clinical staff on non-clinical activities.
Jonathan SongBusiness Development Director, Asia Pacific Region, C3i, Inc, China
Sara diMinnoProject Manager, C3i, Inc, USA
参展商研讨会
本次年会新增参展商研讨会。3家企业将围绕“药品安全，技术创新”分享经
验。
昆泰公司 13:30 - 15:00 (三层 308)
结构性变革：亚洲生物制药企业的未来
amar kUrerShi 博士昆泰公司亚洲区首席医务官兼药物开发主管
甄岭昆泰公司大中华区总经理
北京春天医药 15:30 - 17:30 (三层 308)
关注临床试验中受试者用药安全及风险的主动管控
上市后研究体系和产品安全标准程序的建立以及风险的主动管控
• 安全监管体系对于优化用药安全的重要性• 高标准的安全操作和药物警戒体系• 国际多中心药物上市后研究的风险利益评估
赵子贤 博士美国Amylin Pharmaceuticals, Inc. 全球药品安全副总裁药物流行病学总监(药物警戒-流行病学)安进公司全球药品安全监查部总监安进公司药品安全决策委员会主席
从I期临床研究谈谈药物研发早期的安全性问题
• 安全性的分类• 非预期的安全性• 非预期安全性的案例分析
胡蓓 博士中国北京协和医院临床药理中心主任医师
c3i13:30 - 15:00 (三层 308)
电子临床软件全球部署及支持的最佳实践
讨论客服中心如何为全球临床试验基地提供单点联系的综合技术支持服务，并确保精确的数据收集，减少试验人员花费在技术及软件方面的时间，提高
临床试验效率。
宋康中国科睿特客服科技(大连)有限公司亚太地区业务拓展总监
萨拉 • 狄米诺中国科睿特客服科技 (大连)有限公司项目经理
NEW EXPERIENCES
tuesDay, may 145月14日 星期二
WeDnesDay, may 155月15日 星期三
28
2013年5月12日 星期日 | 会前专题研讨会
07:30-16:00 一层，注册台 会议注册
08:30-17:30 二层，201B 专题研讨一(全天) 运用数据分析技术监控和评价临床研究质量和结果
二层，201C 专题研讨二(全天) 原料药和制剂的稳定性要求与实践
二层，201D 专题研讨三(全天) 肿瘤临床试验中的数据管理
二层，203C 专题研讨四(全天) 从药物监管角度看MedDRA (ICH国际医学用语词典) 在临床试验药物安全和药物警戒方
面的应用
二层，201A 专题研讨五(全天) 全球性药物临床试验的原则和案例研究
三层，307 专题研讨六(全天) 药品安全和原料药: 全球对原料药的监管及法律的要求和实践
10:00-10:30 一层，展厅 茶歇
12:00-13:00 二层，二号厅 午餐
15:00-15:30 一层，展厅 茶歇
2013年5月13日 星期一 | 会议日程(第一天)
07:30-16:00 一层，注册台 会议注册
13:30-17:30 一层，展厅 展览开放
13:30-17:30 二层，一号厅 全体大会
15:00-15:30 一层，展厅 茶歇
15:30-17:30 二层，一号厅 主治嘉宾演讲 促进药物创新，保障患者安全 主旨嘉宾：桑国卫 中国药学会理事长 中国工程院院士
风险管理计划：促进创新确保患者安全
主旨嘉宾：Patrizia A. CAVAZZONI 医学博士 辉瑞全球研发中心高级副总裁 全球安全和上市产品及仿制药物监管部负责人
艾滋病病毒携带者治疗药物现状和期待
主旨嘉宾：孟林 北京爱之方舟感染者信息支持组织负责人 中国艾滋病病毒携带者联盟秘书处协调员
中国全球基金项目国家协调委员会非工委代表
17:30-19:30 一层，展厅/二层， 二号厅
欢迎招待会 — 中国之夜 DIA中国五周年庆典
2013年5月14日 星期二 | 会议日程(第二天)
07:30-16:00 一层，注册台 会议注册
08:30-17:30 一层，展厅 展览开放
08:30-10:00 一层，5 C+F T 1-1 成功的全球临床试验 – 优化利益，降低风险
一层，5 A+B+G+H T 2-1 固定剂量复方制剂(FDCs)在中国及全球的发展
一层，5 D+E T 3-1 上市批准前的药物警戒 – 探索研究
二层，201 A T 4-1 安全性信号检测和效益/风险定量评估(一)
二层，201 B+C T 5-1 确保细胞/基因疗法和血液制品的创新和安全
二层，201 D T 6-1 仿制药与参比制剂之比较与评价 – 仿制药质量一致性评价 (一)
二层，203 C T 7-1 开发适用于中国及全球的创新性中药
10:00-10:30 一层，展厅 茶歇
10:30-12:00 一层，5 C+F T 1-2 临床试验中各方的协调与沟通
一层，5 A+B+G+H T 2-2 生物类似药新的监管：挑战与机遇
一层，5 D+E T 3-2 产品批准上市后的药物警戒 – 长期的任务
二层，201 A T 4-2 安全性信号检测和效益/风险定量评估(二)
二层，201 B+C T 5-2 流感大流行应急准备原则以及批准上市后疫苗生产的变更
会 议 活 动 交 流 活 动 会 场 通 知
29
二层，201 D T 6-2 仿制药与参比制剂之比较与评价 – 仿制药质量一致性评价 (二)
二层，203 C T 7-2 中药开发的案例分析与实践
12:00-13:30 二层，一号厅 午餐
2013年5月14日 星期二 | 会议日程(第二天·续)
13:30-15:00 一层，3号会议厅 国家食品药品监督管理总局 (CFDA) 专场会：中国药品上市前和上市后的安全监管
二层，201 B+C T 5-3 细胞药物和生物类似药的研发 - 机遇及监管要求
二层，201 D T 8-1 肿瘤诊断和治疗模式的改变对药物研发的影响
15:00-15:30 一层，展厅 茶歇
15:30-17:30 一层，3号会议厅 国家食品药品监督管理总局 (CFDA) 专场会：中国药品上市前和上市后的安全监管
二层，201 B+C T 5-4 中国与全球的疫苗产品认证和肝炎新疫苗研发
二层，201 D T 8-2 肿瘤靶向创新药物研发策略
17:30-19:30 二层，二号厅 讲者/嘉宾招待酒会
2013年5月15日 星期三 | 会议日程(第三天)
07:30-16:00 一层，注册台 会议注册
08:30-17:30 一层，展厅 展览开放
08:30-10:00 一层，5 C+F T 1-3 GCP临床研究机构
一层，5 A+B+G+H T 2-3 & T 3-3 新药临床试验/IND阶段的风险与受益权衡
一层，5 D+E T 4-3 Meta分析及其在药品开发中的应用
二层，201 D T 6-3 中美植物药监管展望
二层，201 B+C T 9-1 药物毒理：从动物试验到人体试验
二层，201 A T 10-1 科技进展对临床数据管理的影响
二层，203 C T 11-1 医疗器械的创新、监管及研发投资 (一)
10:00-10:30 一层，展厅 茶歇
10:30-12:00 一层，5 C+F T 1-4 从质量保证的角度谈药物警戒
一层，5 A+B+G+H T2-4 & T3-4 美国FDA新药注册申请/NDA和上市后的风险与受益评估及再评价
一层，5 D+E T 4-4 药物研发中的定量科学
二层，201 D T 6-4 全球生物制药法规的发展 – CMC视角
二层，201 B+C T 9-2 GLP法规；数据的质量和完整性
二层，201 A T 10-2 安全数据管理 – 数据管理者的职责
二层，203 C T 11-2 医疗器械的创新、监管及研发投资 (二)
12:00-13:30 二层，一号厅 午餐 / DIA学术沙龙交流活动
13:30-15:00 一层，5 C+F T 1-5 临床研究机构面临的机遇与挑战
一层，5 A+B+G+H T 2-5 在中国开发治疗用生物制品 – CMC视角
一层，5 D+E T 3-5 为患者的利益平衡效益和风险
二层，201 D T 12-1 如何建立双赢关系
二层，201 B+C T 9-3 药物研发的毒理评价和风险评估
二层，201 A T 10-3 数据标准在临床研究中的应用和成功案例 (一)
二层，203 C T 14 药物流行病学的最佳实践和药物安全
15:00-15:30 一层，展厅 茶歇
15:30-17:30 一层，5 C+F T 1-6 中国伦理委员会的职责和发展
一层，5 A+B+G+H T 2-6 创新的标签说明书中心体系在亚洲的应用及与国际体系的整合
一层，5 D+E T 3-6 制定风险管理计划有益于患者吗？
二层，201 D T 12-2 合同研究机构对确保药品安全所起的作用
二层，201 B+C T 13 上市后和实际环境中的药物研究
二层，201 A T 10-4 数据标准在临床研究中的应用和成功案例 (二)15:30 - 16:15 二层，203 C T 15 药品追溯体系建设—药品电子监管
会 议 活 动 交 流 活 动 会 场 通 知
DIA第五届中国年会将围绕“患者关爱与药物安全”的主题，于2013年5
月12-15日在北京国际会议中心隆重召开。中国年会是DIA在中国及亚太地区每
年举办的规模最大的会议之一。
药物安全是当前监管部门和企业界所关注的话题。随着中国社会经济的快
速发展，科技的不断进步，创新药物和治疗手段的不断更新和使用，如何正确
认识药物风险、增强公众用药安全意识、普及医药科学知识，有效管理风险，
乃是21世纪全球所面临的挑战。
本届年会将有来自国内外新药研发机构、临床基地、科研院所、生产厂家
以及药监部门等知名学者、专家、企业家代表、政府官员及媒体参加。届时，
来宾将围绕年会主题，共同探讨业界当前热点话题，并展望中国和世界制药发
展的前景和趋势。
本次大会设有精彩主题演讲、15个专题研讨的40多个分会场。形式包括分
会场报告、焦点论坛、会前专题研讨、壁报及医药展览。
药物信息协会(DIA)第五届中国年会
副主席
药物信息协会(DIA)第六届中国年会
联席主席
药物信息协会(DIA)第五届中国年会
联席主席
谭凌实 博士
辉瑞(中国)研究开发有限公司 总经理
辉瑞全球开发运营副总裁
赵亚军
中国医药国际交流中心主任
赵大尧 医学博士
美国强生药物研发部副总裁
中国研发与科学事务部负责人
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会 前 专 题研讨
(全天)
08:30-17:30 运用数据分析技术监控和评价临床研究质量和结果
08:30-17:30 原料药和制剂的稳定性要求与实践
08:30-17:30 肿瘤临床试验中的数据管理
08:30-17:30 从药物监管角度看medDra (Ich国际医学用语词典) 在临床试验药物安全和药物警戒方面的应用
08:30-17:30 全球性药物临床试验的原则和案例研究
08:30-17:30 药品安全和原料药: 全球对原料药的监管及法律的要求和实践
2013年5月12日 星期日 | 会前专题研讨
目标听众
以下临床研究领域的人员：• 临床管理和运作• 临床信息技术与计算机处理技术• 临床试验数据监查(临床监查，医疗监控)• 数据保障和数据质控• 临床信息学• 药品法规• 数据管理和设计• 电子临床服务商管理• 药物研发
议程
第一节 | 临床研究管理的生物信息工具 i
• 早期研究探索阶段的数据审核
第二节 | 临床研究管理的生物信息工具 II
• 数据质量审查过程• 受试者数据跟踪• CDISC标准数据结构及应用方法
第三节 | 应用先进的报告和分析方法提高临床研发的效能
• 临床研发效率和质量的提高• 资源调配• 研究计划的制定和决策
第四节 | 对全球数据进行有效的数据管理和信息发掘 – Who全球药品监测中
心(umc)的视角 I
• 用于信息发掘的信号检测和方法• 数据转化为信息: 标准化词典和术语的重要性
第五节 | 对全球数据进行有效的数据管理和信息发掘 – Who全球药品监测中
心(umc)的视角 II
• 如何运用Who药物词典对临床试验和安全性数据进行编码
(全天) 专题研讨 一08:30 - 17:30 (12:00 - 13:00 午餐) | 二层，201 b
运用数据分析技术监控和评价临床研究质量和结果
讲授专家
刘川 博士 medidata solutions Worldwide 大中华地区发展总监
eric S. herbeL美国Integrated clinical systems公司总裁
Yutaka SaTo日本medidata solutions公司方案建设部顾问
Madeleine krieg 注册药师瑞典Uppsala监测中心产品经理
Maria LindqUiST 博士瑞典uppsala监测中心总监兼首席执行官
专题研讨介绍
过去的十年中，临床试验的周期和复杂性在不断增加，但药物研发经费却呈现缩减之态，开发方无法在更长期和更复杂的试验中投入更多的资金。因此，寻求更高效和创新的方法来进行临床研究显得迫在眉睫。本研讨会将讨论临床研究数据分析的典型方法和最佳实践范例。议题包括支持临床试验医疗监控运行的数据分析技术类型，风险监控所用CDISC数据结构，以及临床试验阶段和上市后临床研究的试验管理。本研讨会也将讨论基于数据积累的临床数据审核各种方法、临床研究计划制定以及决策。此外，涵盖的话题还包括如何实现更好的资源调配以提高临床研发的效能和质量、受试者数据审查的益处、异常数据检测的方法以及如何进行信号检测。
目的
• 了解应用生物信息工具进行临床数据评价的时机和方法。 • 了解的已出现的新方法，侧重于"病人鉴别/深度发掘"的报告、图解和数
据系统中受试者信息的交互作用。 • 了解如何进一步提高临床研发的效能和质量。• 掌握数据信息转化以便更好调配资源并进行风险决策。• 学会运用全球性词典对临床试验和安全性数据进行编码。
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(全天) 专题研讨 二08:30 - 17:30 (12:00 - 13:00 午餐) | 二层，201 c
原料药和制剂的稳定性要求与实践
讲授专家
阮忠士 博士 美国百时美施贵宝公司分析研发部副总监
卜欣 博士美国百时美施贵宝公司分析和生物分析部高级研究员
专题研讨介绍
稳定性是医药产品的重要质量属性；因此，遵循当前药物规范的稳定性试验方案对药物开发和新药注册至关重要。稳定性试验方案的成功实施要求对全球的药品监管规定、稳定性方法与最佳实践范例有全面的了解。本研讨会将概述美国食品药品监督管理局(FDA)、国际协调组织(ICH)和世界卫生组织(WHO)对药品的稳定性要求，并从监管和技术层面上探讨如何设计高效、规范的全球化药物稳定性试验方案。
目的
• 了解稳定性试验方案在药物开发过程中的重要性• 遵循ICH/WHO与全球的药物规范设计稳定性研究方案• 高效地实施稳定性试验方案• 了解稳定性检测方法的重要性• 全球技术转移的管理• 解读稳定性试验数据
目标听众
• 研发及管理人员• 法规监管人员• 质量保证和质量控制专业人员• 合同研究机构和生产企业• 学术研究机构
议程
第一节 | 药物稳定性的监管要求概述
• 稳定性在药物开发过程中的重要性• cGMP药物稳定性要求概述• ICH药物稳定性指南• 全球化药物稳定性试验方案的要求• 药品保存期的确定
第二节 | 药品稳定性的技术方面实践
• 稳定性检测方法的建立• 强制降解研究的设计• 试验方法的验证和技术转移• 稳定性数据的评估
第三节 | 案例讨论
(全天) 专题研讨 三08:30 - 17:30 (12:00 - 13:00 午餐) | 二层，201 D
肿瘤临床试验中的数据管理
讲授专家
颜崇超 博士辉瑞(中国)研究开发有限公司数据管理部门技术运营负责人
徐莉 医学博士，工商管理硕士美国辉瑞公司肿瘤业务部， 肿瘤中国策略规划、贯彻和全球运作部副总裁
陈丽娟新加坡 InVentiv health clinical 亚太区临床研究执行总监
张薇辉瑞(中国)研发有限公司数据管理部门治疗领域经理
吴沭陵 辉瑞(中国)研发有限公司临床数据管理部门经理
王娟辉瑞(中国)研发有限公司临床数据(肿瘤组)管理员
伍晓华默沙东研发(中国)临床数据管理副总监
专题研讨介绍
在中国临床研究中，肿瘤临床试验占相当大的比重。本研讨会由两部分组成，将分别介绍肿瘤临床试验的基础知识以及肿瘤临床试验各阶段中数据管理的具体操作。
目的
• 介绍肿瘤临床试验的基础知识• 阐述肿瘤临床试验具有特征性的试验设计，疗效评价以及安全性评价• 帮助理解肿瘤试验中各个阶段的数据管理的工作，强调病例报告表的设
计、数据清理、实验室数据管理、实体肿瘤测量以及长期试验的管理• 讨论肿瘤试验中的最佳操作方法。例如，关键数据点的确定，SAE的处
理以及实验室数据的审查等
目标听众
本次研讨会是为希望了解肿瘤临床试验或者肿瘤临床试验数据管理的专业人员设置及下列相关领域的人员：• 临床研究专业人员 • 临床项目管理人员• 临床监查员• 统计学人员
• 试验程序人员
议程
第一节 | 肿瘤学临床研究基础知识
第一部分: 概述
• 肿瘤药物开发• 肿瘤学治疗标准以及相关术语
第二部分: 肿瘤试验的设计和终点
• 肿瘤临床试验的分期以及类型• 肿瘤评价终点(无进展生存期、客观缓解率、总生存期、肿瘤评价标准
1.1)
第三部分: 肿瘤试验进行期
• 知情同意• 现场监查与方案偏离
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第四部分: 安全监测
• 不良事件和严重不良事件• 不良事件通用术语标准(CTCAE)
第五部分: 案例讨论
第二节 | 肿瘤学数据管理员基础知识
第一部分: 试验启动阶段
• 肿瘤试验的病例报告表的设计以及数据库的建立• 肿瘤学试验的治疗周期• 肿瘤学试验中有效性数据的收集与测量
第二部分: 试验进行阶段
• 试验数据的清理• 肿瘤学研究中本地实验室数据与正常范围的处理• 支持有关有效性与安全性数据的临床审查• 第三方数据的审查对数据管理员的挑战 • 外部数据的处理和一致性检查• 第三部分: 试验结束期
• 中期分析时数据库临时性的锁定• 长期试验的管理与跟踪
第四部分: 肿瘤试验的最佳实践
• 肿瘤试验中的关键数据点• 了解必要数据和最佳数据• SAE 处理• 实验室数据审核• 肿瘤测量
(全天) 专题研讨 四08:30 - 17:30 (12:00 - 13:00 午餐) | 二层，203 c
从药物监管角度看MedDRA(ICH国际医学用语词典)在临床试验药物安全和药物警戒方面的应用
讲授专家
anna Zhao-wong 医学博士美国MedDRA Maintenance and Support Services Organization副总监
Sonja braJovic 医学博士美国FDA药物审评和研究中心 监测和流行病学办公室 MedDRA协调员
专题研讨介绍
本次研讨会将重点放在MedDRA在临床试验安全性和药物警戒方面的应用，包括监管方面的观点。内容含有如何按照ICH认可的《MedDRA编码：考虑要点》和《MedDRA数据检索和显示：考虑要点》指南文件统一精确地使用MedDRA术语编码、检索、显示临床药物安全信息数据的方法,如何使用MedDRA标准分析查询工具(SMQs)帮助识别，检测药物安全信号。同时还将介绍美国FDA不良事件报告系统(FAERS)的实施，描述标准术语在药品安全数据编码和分析中使用。鼓励参加者带有关MedDRA编码、数据检索/分析的问
题参加交流和讨论。
目的
• 描述如何使用MedDRA术语进行不良事件数据编码• 阐述检索和分析MedDRA编码数据的策略及其在临床药物安全性和药物
警戒中的应用• 了解美国FDA如何使用MedDRA对FDA不良事件报告系统(FAERS)数据
进行上市后药物警戒。并在新药审评中将其运用于对临床试验安全性数据的分析
目标听众
本次研讨会是为以下有MedDRA基本知识并想探索其在临床药物安全和药物
警戒中应用的专业人士设计的:• 药物警戒和临床研究的专业人员• 临床数据管理人员• 医学写作者
• 法规及监管人员
议程
第一节 | MedDRA简介
第二节 | MedRA编码和ICH认可的《MedDRA编码: 考虑要点》
• 《MedDRA编码: 考虑要点》简介• 从美国FDA视角通过编码示例分析数据质量问题 • 编码练习• 问答与互动
第三节 | MedDRA数据分析和ICH认可的《MedDRA数据检索和显示: 考虑要
点》
• 《MedDRA数据检索和显示: 考虑要点》简介• 编写MedDRA查询• MedDRA查询编码练习• MedDRA标准分析查询工具• 自定义搜索• 从美国FDA AERS数据库和新药安全审查的例子中看FDA如何使用
MedDRA进行信号检测• 问答与互动
第四节 | MedDRA版本更新
(全天) 专题研讨 五 08:30 - 17:30 (12:00 - 13:00 午餐) | 二层，201 a
全球性药物临床试验的原则和案例研究
讲授专家
王武保 博士默沙东研发(中国)有限公司生物统计与研究决策科学部 – 亚太区执行总监
寿琼 博士默沙东研发(中国)有限公司生物统计与研究决策科学部 – 亚太区资深生物统计师
hsien-Ming James hUng 博士美国FDA药品审评与研究中心生物统计处处长
Sue-Jane wang 博士美国FDA药品审评与研究中心生物统计处， 转化科学处副处长
安藤 友纪日本药物医疗器械监督局生物统计组, 药物评价中心资深生物统计师
专题研讨介绍
近年来，全球性临床试验在药物研发中占有越来越大的比重。ICH指南以及区域的临床监管指南已经明确阐述了全球性临床试验的基本科学原则。本研讨会通过心血管、中心神经系统、抗感染、肿瘤和其他治疗领域的案例阐述药物监管、统计学、临床和运作原则。每一个案例将介绍疾病的背景、临床试验的设计、药物全球发展的战略、临床试验的结果以及药物监管部门审评的考量。
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目的
• 回顾全球性临床试验中药物监管、统计学、临床学和运作的原则• 通过实例了解在不同区域开展临床药物研发及注册的策略• 通过实例了解不同地区对注册的法规要求
目标听众
以下领域的人员：• 定量科学• 法规监管• 制药行业(临床前、上市前、上市后的开发)• 合同研究组织• 政府机关• 学术界/研究机构
议程
第一节 | 心血管和中心神经系统案例以及原则
• 一致性和不一致性的概念• 全球和区域临床试验的优势以及挑战
第二节 | 全球和地区药物基因组学试验案例及原则
• 药物基因组学试验的设计和分析的特点• 全球和区域药物基因组学试验的优势以及挑战
第三节 | 亚洲临床试验案例及原则
• 全球，亚洲和地区临床试验设计的选择以及发展战略• 对全球临床试验中总体及区域结果的评估
第四节 | 问答与互动
(全天) 专题研讨 六 08:30 - 17:30 (12:00 - 13:00 午餐) | 三层，307
药品安全和原料药: 全球对原料药的监管及法律的要求和实践
欢迎致辞
中国食品药品监督管理总局代表
苏岭 博士DIA全球理事会主席盛德国际律师事务所生命科学战略顾问
nicole Taylor SMiTh 法学博士美国食品药品监督管理局驻中国办公室副主任
议程
第一节 | 2012年中美原料药法规监管和合作会议回顾总结
Jeffrey gren美国商务部健康与消费产品司司长
第二节 | 美国及欧盟对原料药和化学品生产的定义和监管以及原料药在全球
药品安全中的作用
有关欧盟原料药认证新要求和国际合作机遇的讨论
nicole Taylor SMiTh 法学博士美国食品药物监督管理局驻中国办公室副主任
Patrizia ToSeTTi 博士欧盟委员会健康局科学官
第三节 | 企业对原料药监管的思考
维力士吉
葡萄牙好利安制药科学股份有限公司行政总裁，RX-360 Consortium 机构代表
顾桂国
中国中化帝斯曼制药(淄博)有限公司总经理
第四节 | 中国原料药的定义和监管范畴以及执法监督检查手段
中国食品药品监督管理总局 讲者(已邀请)
第五节 | 对原料药生产企业的监督检查及针对未受监管的化学原料的执法合作
Piotr kraUZe欧洲药品管理局检查部科学行政官
王刚 博士美国食品药品监督管理局驻中国办公室助理主任
第六节 | 中国、欧盟和美国药典原料药标准的作用
中国药典委员会 讲者(已邀请)
Susanne keiTeL 博士欧洲理事会欧洲药品质量局(EDQM)局长
胡江滨 博士美国药典委员会中华区副总裁
第七节 | 确保原料药质量以及防止销售或出口不受监管或伪造的原料药的法
律和政策
杨晨盛德国际律师事务所北京办事处合伙人盛德中国生命科学业务负责人
刘志伟 教授
北京师范大学法学院
第八节 | 具体法律和政策建议
主持人
Jeffrey greN美国商务部健康与消费产品司司长
中国食品药品监督管理总局 讲者(已邀请)
第九节 | 建议与合作措施
第十节 | 总结
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2013年5月13日 星期一 | 会议日程 (第一天)
现场注册07:30 - 16:00
开幕式(全体大会)13:30 - 17:30
DIA主席致开幕辞
苏岭 博士DIA全球理事会主席盛德国际律师事务所生命科学战略顾问
DIA志愿者杰出贡献奖颁奖仪式
年会主席致辞
谭凌实 博士辉瑞(中国)研究开发有限公司总经理辉瑞全球开发运营副总裁
赵亚军中国医药国际交流中心主任
茶歇15:00 - 15:30
主旨嘉宾演讲15:30 - 17:30
促进药物创新，保障患者安全
桑国卫中国药学会理事长
中国工程院院士
风险管理计划： 促进创新确保患者安全Patrizia a. cavaZZoni 医学博士辉瑞全球研发中心高级副总裁，全球安全负责人及成熟产品药政事务部负责人
艾滋病病毒携带者治疗药物现状和期待孟林北京爱之方舟创办者及负责人中国艾滋病病毒携带者联盟秘书处协调员中国全球基金项目国家协调委员会非政府工作委席位代表
欢迎招待会 — 中国之夜： DIA中国五周年庆典17:30 - 19:30
国家食品药品监督管理总局 (CFDA) 专场会
2013年5月14日 星期二 13:30 - 17:30 一层, 三号会议厅
中国药品上市前和上市后的安全监管
2012年度中国药品审评报告
陈震 博士CFDA药品审评中心 化药药学一部副部长
CFDA 安监司、注册司、评价中心 讲者已邀请
2013年5月14日 星期二 | 会议日程 (第二天)
36
专题 1 | 临床研究与运作
分会场 T 1-1 | 2013年5月14日 星期二 08:30 - 10:00 一层, 5 C+F
成功的全球临床试验 - 优化利益，降低风险
会议主持
顾薇百时美施贵宝(中国)投资有限公司临床运营部高级总监
为确保临床试验的成功,患者的安全和风险管理是关键要素。FDA和EMA颁布了基于风险的监查规范, 中国在参与更多的全球临床同步研发过程中，需将这些国际原则和规范应用于中国和亚洲国家。本专场将深入讨论实施优良临床试验的指导原则。
临床试验的成功要素
John ran kiM韩国ICON公司亚太区临床研究部副总裁
基于风险的监控
elaine hawkingS百时美施贵宝(中国)投资有限公司临床运营部亚太区执行总监
包括中国和亚洲参与的全球临床试验的风险与收益
宫崎 浩一 注册药师日本第一三共制药公司临床运营副总监
专家讨论
分会场 T 1-2 | 2013年5月14日 星期二 10:30 - 12:00 一层, 5 c+f
临床试验中各方的协调与沟通
会议主持
吴第一三共(中国)投资有限公司医药开发总部总经理
专家讨论
纵观整个临床试验的关键路径，从研究方案的确定，IEC/IRB审查，研究合同签署，病人/受试者招募，到安全监测及研究结束，责任各方，如申办者，主要研究者/研究机构，IEC/IRB和CRO等的合作协调和有效沟通对保证高效率、高质量的临床试验至关重要。
来自临床研究中心(基地)、伦理委员会、申办方及CRO的各方人员将介绍各自工作重点领域，以及如何建立通畅的交流沟通机制及协调合作。协调一致以确保以患者安全和权益为中心的临床研究的高效运作。
专家讨论组
徐仲鍈 教授香港中文大学公共卫生学院临床研究中心生物统计处处长
李树婷中国医学科学院肿瘤医院GCP中心办公室主任
顾薇百时美施贵宝(中国)投资有限公司临床运营部高级总监
陈莉 医学博士ICON中国项目管理部负责人
分会场 T 1-3 | 2013年5月15日 星期三 08:30 - 10:00 一层, 5 c+f
GCP临床研究机构
会议主持
陈华杨森(中国)制药研发质量保证部临床质量监控/药物警戒组总监
李树婷中国医学科学院肿瘤医院GCP中心办公室主任
专家讨论
本专场将讨论在临床试验过程中常见的GCP质量问题。参加讨论的人员包括涉及临床试验不同领域的专家, 药监局官员，临床试验基地主任，制药公司临床运营部门的主管及质量保证部门的代表。专家将根据临床研究及监管的经验交流观点。目的是促进相互的理解，提高临床试验的质量。
专家讨论组
李树婷中国医学科学院肿瘤医院GCP中心办公室主任
戴欣北京诺华制药有限公司国际临床开发部大中国、亚太、中东及非洲区域高级总监
李庆红辉瑞医疗(中国)质量保证部亚洲地区负责人
cFda药品注册司 讲者已邀请
分会场 T 1-4 | 2013年5月15日 星期三 10:30 - 12:00 一层, 5 c+f
从质量保证的角度谈药物警戒
会议主持
李庆红辉瑞医疗(中国)质量保证部亚洲地区负责人
为保证病人的安全，全球的医药监管部门竭力加强对新药的安全监督和管理。本专场旨在解读欧盟新药安全监督和管理的最新法规，分享和学习来自监管部门视察和申办者内部稽查的经验和教训，共同思考如何规划未来，如何符合法规要求、提高工作有效性及改进药物警戒的流程。
本专场并将侧重介绍欧盟药物警戒法规最新发展、药物警戒视察中常见问题、企业内部稽查的经验。
欧盟药物警戒法规的最新进展和视察中常见问题
carrie ScoTT英国药品医疗产品监管局GPvP运营经理，资深药物警戒监察员
企业内部药物警戒稽查
deborah driScoLL 博士美国辉瑞公司医疗质量保证部副总裁
2013年5月14日 星期二 | 会议日程 (第二天) 2013年5月15日 星期三 | 会议日程 (第三天)
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分会场 T 1-5 | 2013年5月15日 星期三 13:30 - 15:00 一层, 5 c+f
临床研究机构面临的机遇与挑战
会议主持
李海燕 教授北京大学第三医院药物临床试验机构主任北京大学临床研究所副所长
李树婷中国医学科学院肿瘤医院GCP中心办公室主任
近年来，临床研究数量在快速增长，国家药监局也更关注研究质量，不仅通过对申报项目的现场核查进行监管，同时在机构复核检查中也将此作为重要内容之一。研究者在承担大量临床研究的同时，还要确保研究质量。面对这样的挑战，临床研究机构应如何加强管理，为临床试验提供一个高效、有序的GCP平台。本会场将针对这些问题进行深入的讨论。
高效规范的管理程序对临床试验受试者安全性的保障作用
梁茂植 研究员华西医院国家药品临床试验机构副主任兼I期临床试验研究室主任 临床药理研究室主任华西医院国家药物临床试验机构/GCP中心负责人
2012 年临床研究机构的问卷调查及分析
李树婷中国医学科学院肿瘤医院GCP中心办公室主任
在中国药物研发中临床试验机构的作用
李海燕 教授北京大学第三医院药物临床试验机构主任北京大学临床研究所副所长
分会场 T 1-6 | 2013年5月15日 星期三 15:30 - 17:30 一层, 5 c+f
中国伦理委员会的职责和发展
会议主持
刘海涛 国际公共卫生学硕士葛兰素史克(中国)投资有限公司 全球质量合规部 亚太地区临床发展质量保证部高级顾问
本专场将着重于中国目前的伦理审批和伦理委员会的建设: 优势和挑战. 内容不仅将侧重于内部架构和系统的建设，并从保护患者安全角度讨论目前伦理委员会的职责。本专场旨在促进发展高效、高质量伦理审查体系。
通过伦理委员会审查确保患者安全
cristina e. TorreS 博士菲律宾亚太地区伦理审查委员会亚洲区协调员
伦理审查中的挑战与思考
汪秀琴 教授 博士江苏省人民医院科技处副处长，伦理委员会副主任委员
台湾伦理委员会基础设施策略规划 — 临床研究之关键主动支持
陈恒德 医学博士台湾生技整合育成中心医务长
专家讨论
专题 2 | 监管科学
分会场 T 2-1 | 2013年5月14日 星期二 08:30 - 10:00 一层, 5 a+b+g+h
固定剂量复方制剂(FDCs)在中国及全球的发展
会议主持
闫小军 工商管理硕士拜耳医药保健有限公司全球注册战略发展特药负责人
开发固定剂量复方制剂(FDCs)从公众健康角度来说越来越重要。这类药品用途很广，例如治疗HIV、高血压、和口服避孕等，临床上确实增加疗效，减少不良反应。此外，FDC制剂的成本要小于同时分别给药。由于减少了病人服用的药片/丸等，从而提高了用药依从性。
本专场来自制药企业和医院的讲者将分享全球FDC的发展及其对患者的益处。药监局审评中心的讲者将介绍中国相应的原则，法规要求以及关注点。
固定复方制剂: 在中国控制高血压的意义与研究进展
王文 教授中国医学科学院阜外医院国家心血管病中心
跨国公司如何科学理性地开发FDCs dan PaULSon 博士美国拜耳医药保健有限公司全球临床负责人
中国固定复方制剂发展的基本原则，监管要求及相关考量
康彩练中国药品审评中心化药临床二部高级审评员
分会场 T 2-2 | 2013年5月14日 星期二 10:30 - 12:00 一层, 5 a+b+g+h
生物类似药新的监管： 挑战与机遇
会议主持
李宁 医学博士赛诺菲(中国)药学与医学政策亚洲区副总裁
自美国2011年颁布了生物类似药指南后，如何进行符合该指南要求的临床研究已引起各方的关注。本场将讨论生物类似药开发的法规要求和试验设计。
美国FDA生物类似药指南要求
龚兆龙 博士美国FDA同仁会国际部成员前美国FDA新药审评员北京莱博药业总经理
如何设计生物类似药的临床研究
彭健 博士赛诺菲(中国)亚太研发中心科学顾问
生物类似药CMC相关问题
段海清 博士中国联想之星投资副总裁
38
分会场 T 2-3 | 2013年5月15日 星期三 08:30 - 10:00 一层, 5 a+b+g+h
新药临床试验/IND阶段的风险与受益权衡
会议主持
Florence hoUn 医学博士，公共卫生硕士美国FDA同仁会国际部联席主席前美国FDA药品审评及研究中心药品评价三处处长美国塞尔基因公司法规政策与战略副总裁
风险与受益评估是监管决策的基础。尽管风险／受益评估在过去的十年中取得了进展，这一领域在目前仍面临着巨大的挑战，尤其是在所开发药物的受益还无法确定的新药临床试验(IND)阶段。本专场为风险／受益评估主题的第一部分，将介绍美国FDA和中国CFDA/CDE的观点。
美国FDA在临床试验阶段对药品受益/风险的权衡
Mark J. goLdberger 医学博士，公共卫生硕士前美国FDA药品审评与研究中心药品审评四部部长 美国FDA同仁会成员 美国雅培制药法规政策部副总裁
临床试验暂停(Clinical Hold)－美国FDA在新药临床试验阶段进行风险管理的重要措施
robert J. MeYer 医学博士前美国FDA药品审评与研究中心药品审评二部部长 美国FDA同仁会成员 美国弗吉尼亚大学医学院公共卫生科学系副教授，弗吉尼亚州立监管科学中心主任
美国FDA权衡药品受益/风险的统计学考量
李宁 医学博士赛诺菲药学与医学政策亚洲区副总裁
中国药品审评中心对临床试验申请的审批
杨志敏中国药品审评中心化药临床一部副部长
专家讨论
分会场 T 2-4 | 2013年5月15日 星期三 10:30 - 12:00 一层, 5 a+b+g+h
美国FDA新药注册申请/NDA和上市后的风险与受益评估及再评价
会议主持
Mark J. goLdberger 医学博士，公共卫生硕士前美国FDA药品审评与研究中心药品审评四部部长美国FDA同仁会成员美国雅培制药法规政策副总裁
风险与受益评估是监管决策的基础。不同的监管机构对同一类药品申请有不同的审评结论和决策。本专场为风险／受益评估主题的第二部分，将介绍NDA及上市后，如何考量风险和受益，并着重介绍美国专家顾问委员会的作用。
NDA及上市后风险及效益平衡观
robert J. MeYer 医学博士前美国FDA药品审评与研究中心药品审评二部部长美国FDA同仁会成员 美国弗吉尼亚大学医学院公共卫生科学系副教授，弗吉尼亚州立监管科学中心主任
美国FDA借助外部咨询委员会对新药/NDA进行风险/受益评估
Florence houn 医学博士，公共卫生硕士美国FDA同仁会国际部联席主席前美国FDA药品审评及研究中心药品评价三处处长美国塞尔基因公司法规政策与战略副总裁
风险效益观在上市申请审评中的体现
徐丽娟台湾卫生署药品食品监督局药品审评中心临床科学处首席执行官
上市后的风险效益再评价
詹思延 教授, 医学博士北京大学医学部流行病和生物统计系副主任
专家讨论
分会场 T 2-5 | 2013年5月15日 星期三 13:30 - 15:00 一层, 5 a+b+g+h
在中国开发治疗用生物制品 – CMC的视角
会议主持
吕玉真罗氏亚太药品开发中心亚太注册事物负责人
在解决未能满足的医疗需求方面，已知治疗用生物制品正扮演着日益重要的作用。在中国及时引入新的、安全有效的治疗用生物制品是国内外制药企业和监管机构的共同目标。在这个专题的演讲和讨论中，来自制药企业和监管机构的代表将从CMC的视角来分享和讨论如何加速临床研究申请的批准，包括申报资料准备，顺利启动和完成样品检验，总结和分析所遇到的挑战和机遇，并提出可能的解决方案。
生物制品临床申请中申报资料的准备和样品检验
程慧旸 博士嘉和生物药业有限公司医学注册部总监
蔺亚萌罗氏(中国)制药有限公司政策事物经理
饶春明中国食品药品检定研究所生物制品检定所重组药物室主任
专家讨论组
以上讲者及
徐砺新 医学博士美国FDA药品审评与研究中心 单克隆抗体处，生物科技产品办公室，生物药品质量评审专家
anthony ridgwaY 博士加拿大卫生部健康产品和食品局生物和基因疗法处首席监管科学家
分会场 T 2-6 | 2013年5月15日 星期三 15:30 - 17:30 一层, 5 a+b+g+h
创新的标签说明书中心体系在亚洲的应用及与国际体系的整合
会议主持
rie MaTSUi 注册药师日本辉瑞公司WSR国际和全球产品信息部区域标记组亚洲区总监
岸达生日本药物医疗器械监督局药物安全二处风险管理主任
许多跨国公司使用集中统一的标签说明书模式。支持该模式的核心数据表(CCDS)由公司总部管理，而本地药品文件和病人使用说明书由所在地的公司管理。本专场将对CCDS、USPI、EU-SPC等全球标签说明书体系进行综
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述，并通过亚洲区的实例，探讨发展的前景。本专场还将从确保病人信息安全的视角，阐述制药产业对全球标签说明书体系的管理。
跨国制药企业的全球药物安全说明书体系
Matthias boedding 教授，医学博士拜耳(中国)医药保健有限公司, 全球研发北京中心全球药物警戒-风险管理部负责人
一个亚洲区管理药物说明书的创新模式
rie MaTSUi 注册药师日本辉瑞公司WSR国际和全球产品信息部区域标记组亚洲区总监
日本药物说明书的政策法规
岸达生日本药物医疗器械监督局药物安全二处风险管理主任
美国和欧洲的全球药物说明书流程以及相关组织
Jeffery ho英国WCI咨询公司负责人
专题 3 | 药物安全和警戒
分会场 T 3-1 | 2013年5月14日 星期二 08:30 - 10:00 一层, 5 D+e
上市批准前的药物警戒 — 探索研究
会议主持
夏峰 医学博士美国辉瑞全球研发有限公司 全球安全和法规部 安全评价组医疗总监
药物警戒活动已转向更为早期、主动的风险和潜在效益评估，并成为新药开发及上市前评估过程中的重要内容。生物学、药理学等基础科学的进步和药物研发过程中对信息技术的运用已经促成对以往难以获得的更为复杂药物的开发，并能更早地在药物开发过程中进行全面深入地风险效益评估。
公众对新药安全的加倍关注以及科学新发展促进了创新药开发方、药监部门和医务工作人员的紧密合作，以制订相关的指南，加强在药物早期开发阶段的药物警戒和安全风险管理。同时，制药企业也在不断努力适应新的要求以确保病人安全。
本专场将分享关于评估、决策、沟通和规划的思路和观点，以及一个需对病人安全有特殊考量的肿瘤临床试验。
从首次人体试验到批准上市: 创新药开发中的安全性关键要素 (评估、决策和沟通)
张丹 医学博士，公共卫生硕士方恩医药发展有限公司总裁兼首席执行官
新药上市批准前的安全评估 — 主要考量及案例回顾
陈之键 医学博士，工商管理硕士阿斯利康(中国)全球药物研发 中国区副总裁兼负责人
专家讨论
• 药品上市申请的临床安全性审评• 上市批准前安全风险评估的实践• 个例和整合的药物安全报告• 上市批准前的药品安全性信息沟通
以上讲者及
Steven R. BAILEY 医学博士，工商管理硕士美国辉瑞公司全球安全策略部副总裁，新兴市场和成熟产品部事业发展组负责人
分会场 T 3-2 | 2013年5月14日 星期二 10:30 - 12:00 一层, 5 D+e
产品批准上市后的药物警戒 — 长期的任务
会议主持
裘行敏辉瑞(中国)研发中心全球安全和法规部总监
程刚 国家食品药品监督管理总局药品评价中心，国家药品不良反应监测中心主任助理
药品监管机构基于新药申请上市时提供的信息批准药品上市。随着药品在不同患者群中的使用和患者数量的增多，对于该药品的安全性的了解也随之变化。除了常规的各项上市后安全性监测工作，还需要对某些有特殊安全性考虑的药品采用额外的药物警戒方法。究竟采用何种最佳方法，取决于药物、患者群和安全信号。随着主动监测成为药物警戒的发展新领域，严格设计的观察性研究在实践中已经被大量应用。本专场将深入讨论上市后药品药物警戒的方法和实际应用。
"祖父药"一定安全吗？— 苯丙醇胺(PPA)的案例
庄易 博士美国FDA药品审评与研究中心 生物统计处副处长
药物安全的主动监测 — 概念，方法学以及发展
周晓枫 博士美国辉瑞制药公司 全球安全和药政事务部总监
主动监测的应用 — 实例
andy STergachiS 博士美国华盛顿大学流行病学及全球卫生学教授 华盛顿大学公共卫生学院全球医药专业主任
专家讨论
• 上市后的安全性研究 — 什么是最佳途径？• 实际环境中的研究• 上市后不良反应信息收集所面临的挑战 — 从对漏报8万不良反应报告的
评论中所得到的启示
以上讲者及
谢珺 辉瑞(中国)全球安全和法规部 安全评估及报告组总监
分会场 T 3-3 | 2013年5月15日 星期三 08:30 - 10:00 一层, 5 a+b+g+h
新药临床试验/IND阶段的风险与受益权衡
(见分会场T2-3，第38页 )
分会场 T 3-4 | 2013年5月15日 星期三 10:30 - 12:00 一层, 5 a+b+g+h
美国FDA新药注册申请/NDA和上市后的风险与受益评估及再评价
(见分会场T2-4，第38页 )
谢
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分会场 T 3-5 | 2013年5月15日 星期三 13:30 - 15:00 一层, 5 D+e
为患者的利益平衡效益和风险
会议主持
hugues berard 医学博士，工商管理硕士益普生(法国)研发公司副总裁及代理首席医务官
高杲辉瑞(中国)研究开发有限公司，安全监测及风险管理部副总监
对药物效益风险的评估和权衡贯穿于药品的研发、审评、上市后监测的整个生命周期。如何建立能被广泛认可的评估模式成为药监部门和制药行业关注的问题。近年来，不少国家的药品监管部门、制药行业均相继开展药物效益风险评估方法的研究项目，并取得进展。本专场的讨论旨在:
• 介绍药物效益风险评估方法研究的进展和实施• 从制药行业角度探讨当前业界和监管部门采用的评估方法及相应问题• 分享制药公司在进行药物研发中进行效益风险分析的方法和实例• 探讨如何使各方在科学的评估模式上达成共识，以及其在药物创新中的
作用
全球药物效益风险研究进展：欧洲protect项目
Juhaeri JUhaeri 博士美国赛诺菲药物警戒和流行病学部门副总裁及药物流行病学负责人
药物效益风险评估的实施：制药公司合作模式案例分析
hugues berard 医学博士，工商管理硕士益普生(法国)研发公司副总裁及代理首席医务官
以中国为先导的药物研发中的效益-风险评估和风险管理
牟骅 博士和记黄埔医药(上海)有限公司执行副总裁及首席医务官
专家讨论
• 如何就科学的评估方式达成共识• 效益风险评估模式在药物创新中的作用
分会场 T 3-6 | 2013年5月15日 星期三 15:30 - 17:30 一层, 5 D+e
制定风险管理计划有益于患者吗？
会议主持
周凌云 医学博士，公共卫生硕士赛诺菲全球药物警戒及流行病部 国际药物警戒协调员
茅蕴 工商管理硕士辉瑞(中国)研究开发有限公司 安全监测及风险管理部总监
有效的风险管理计划已在药物研发和上市阶段发挥重要的作用。然而对于其可能给医疗系统增加负担并可能限制患者获得药品的争议仍旧存在。风险管理计划正趋于全球性的协调和统一，但区域的差异需加以考虑，因为不同地区的患者人群和医疗服务体系的模式会很大程度地影响风险鉴别和分类, 以及对降低风险工具的选择。有效的风险计划应基于对患者的最佳保护。本专场重点：
• 介绍侧重于亚洲的全球风险管理计划• 介绍CIOMS工作组在有效降低风险方面的进展• 分享如何有效应用流行病学研究评估风险最小化手段• 讨论风险管理协调统一及工具应用
风险管理计划的全球概况和亚洲特色
william gregorY美国辉瑞公司安全策略部高级总监
亚洲风险管理：日本的经验
Stewart gearY 医学博士卫材(日本)全球医学事物副总裁暨首席医学官
观察性试验在风险识别分类以及评估风险最小化工具中的应用实践
Juhaeri JUhaeri 博士美国赛诺菲公司药物警戒和流行病学部门副总裁及药物流行病学负责人
专题 4 | 统计学
分会场 T 4-1 & T 4-2 | 2013年5月14日 星期二 08:30 - 12:00 二层, 201 a
安全性信号检测和效益/风险定量评估
会议主持
袁维颖 博士 强生药物研发 中国生物统计和统计程序部门总监
曲鹏 博士辉瑞(中国)研究开发有限公司统计部总监
保护病人的安全在药品开发和医疗中至关重要。辨别潜在性安全信号和效益/风险定量评估是安全评价的一个组成部分，统计学在其中起到不可少的作用。本专场从制药界和监管部门两个角度进行探讨。
QTc临床试验中的统计考量
庄易 博士美国FDA药品审评与研究中心 生物统计处副处长
安全性信号检测的序贯GLR检验方法
陈杰 博士默沙东北京药物研发有限公司生物统计总监
效益和风险的统计考量
Marcia LevenSTein辉瑞全球研发统计副总裁
安全性信号检测的贝叶斯收缩估计
戴鲁燕 博士上海勃林格殷格翰药业有限公司 生物统计副总监
药物基因组学的安全性
Sue-Jane wang 博士美国FDA药品审评与研究中心生物统计处，转化科学处副处长
专家讨论
分会场 T 4-3 | 2013年5月15日 星期三 08:30 - 10:00 一层, 5 D+e
META分析及其在药品开发中的应用
会议主持
张维 博士上海勃林格殷格翰药业有限公司，亚太、中东和北非区生物统计和数据管理部执行总监
Meta分析是医学研究和药品开发中应用最广泛的方法之一，例如，产生假设，判定非劣效性临床试验的界值，以及基于大规模临床试验的治疗效果的整合分析。但是该方法如果使用不当，价值就会因各种偏差而减弱。本会场将推动Meta分析的规范应用并介绍其最新发展。
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Meta分析在药品安全评估中的应用：统计学挑战与最佳实践范例
george qUarTeY 博士美国Genentech公司Principal统计师
Meta分析与混合疗法比较数据 — 治疗网络中直接证据和间接证据的测量与报告：方法、软件和示例
hendrik SchMidT 博士德国勃林格殷格翰药业有限公司生物统计部副总监
Meta-回归及其在临床试验中的应用
陈峰 教授, 博士南京医科大学公共卫生学院院长
分会场 T 4-4 | 2013年5月15日 星期三 10:30 - 12:00 一层, 5 D+e
药物研发中的定量科学
会议主持
王武保 博士 默沙东研发(中国)有限公司生物统计和研究决策科学部 – 亚太区执行总监
宋杨 博士默沙东研发(中国)有限公司 生物统计和研究决策科学部亚太分部 后期研发统计组首席统计学家
药物研发中的定量科学涵盖了生物统计学、流行病学、卫生经济统计学、科学应用编程和数据管理等多门学科。这些学科在药物研发领域共同发挥着越来越大的作用。这些作用不仅体现在战略的制定和实施上，也体现于药监申请递交和药监决策制定；它不仅反映了发达地区的药物研究现状，也反映了新兴市场地区的情况。本专场将探讨定量科学专业人员面临的挑战和机遇。
药品研发中的定量科学的新议题
hsien-Ming James hUng 博士美国FDA药品审评与研究中心生物统计处处长
专家讨论
• 建模与模拟的作用• 受益风险定量评估• 复杂的临床试验设计• 生物标识的预示或预后性• 整合分析或Meta分析的效用与缺陷• 全球化
专家讨论组
hsien-Ming James hUng 博士美国FDA药品审评与研究中心生物统计处处长
Sue-Jane wang 博士美国FDA药品审评与研究中心生物统计处，转化科学处副处长
安藤 友纪日本药物医疗器械监督局生物统计组, 药物评价中心资深生物统计师
Joan Shen 医学博士辉瑞(中国)临床发展部高级总监
专题 5 | 疫苗和生物制品
分会场 T 5-1 | 2013年5月14日 星期二 08:30 - 10:00 二层, 201 b+c
确保细胞/基因疗法和血液制品的创新和安全
会议主持
Florence houn 医学博士，公共卫生硕士美国FDA同仁会国际部联席主席前美国FDA药品审评及研究中心药品评价三处处长美国塞尔基因公司法规政策与战略副总裁
本专场将综合介绍中国CFDA/CDE及美国FDA生物制品评价研究中心对血液供应、细胞、组织和基因疗法的质量、有效性以及病人安全的监管方法。
FDA对细胞/基因疗法药物的安全性和有效性的要求
胡劲捷 博士 FDA同仁会会员前美国FDA/CBER血液研究和评价办公室，高级审评官员美国生物咨询公司高级顾问
中国关于细胞/基因疗法安全性及有效性法规方面进展的报告
沈琦
中国食品药品检定研究院生物制品检定所所长
FDA在血液制品安全性方面的职责
胡劲捷 博士 FDA同仁会会员前美国FDA/CBER血液研究和评价办公室，高级审评官员美国生物咨询公司高级顾问
确保中国血液制品的安全与有效性
CFDA注册司 讲者已邀请
分会场 T 5-2 | 2013年5月14日 星期二 10:30 - 12:00 二层, 201 b+c
流感大流行的应急准备原则以及批准上市后疫苗生产的变更
会议主持
Florence hoUn 医学博士，公共卫生硕士美国FDA同仁会国际部联席主席前美国FDA药品审评及研究中心药品评价三处处长美国塞尔基因公司法规政策与战略副总裁
确保疫苗的安全对于各国监管当局都是困难但又必须履行的职责，目的是为了促进公众健康，督促生物制药企业承担责任。美国FDA和中国CFDA有多年的经验。为确保疫苗的安全有效，监管部门不仅鼓励采用新技术以推进高质量和高效率的生产，也需要通过合适的验证及临床或非临床的实验研究来证明因此引起的变化没有给产品的安全性和有效性造成不良影响，这是一个非常艰巨的挑战。本专场将介绍美国和中国关于流感疫苗生产、应急准备和安全性方面所开展的工作。
FDA和WHO流感大流行疫苗的应急准备工作
Sara e. gagneTen 博士美国FDA生物制品审评与研究中心 病毒产品部 疫苗审评与研究处副处长
推进中国疫苗安全性和创新性
罗建辉中国药品审评中心生物制品药学部副部长
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FDA的疫苗申请：有关安全性和上市后变更的法规
Sara e. gagneTen 博士美国FDA生物制品审评与研究中 心病毒产品部 疫苗审评与研究处副处长
分会场 T 5-3 | 2013年5月14日 星期二 13:30 - 15:00 二层, 201 b+c
细胞药物和生物类似药的研发 - 机遇及监管要求
会议主持
史力 博士上海泽润生物科技有限公司首席执行官
生物类似药和细胞疗法已进入生物制品开发及临床应用的热点阶段。这些领域对当前和未来以生物为基础的药品开发发挥着越来越重要的作用。随着新技术的发展，新的疾病治疗方法包括细胞治疗，在逐渐进入实践，其治疗方法也在面临技术和监管方面的双重挑战。另外生物类似药进入监管成熟的国家仍需要做很多工作以满足法规要求。本专场将讨论细胞治疗和生物类似药开发、质量、安全性和监管要求的现状和机遇。
细胞治疗及发展和现状及其在医学美容治疗中的应用
朱宁文 博士江苏华亿细胞组织工程有限公司创办人兼首席科学家
按照国际GLP标准对中国新生物医药进行安全评价研究
徐景宏 博士中国Innostar公司国家上海新药安全评价研究中心副总裁及首席安全官
从监管的角度来看将中国生物类似药引进欧盟的期望和机会
hoss dowLaT 博士德国PharmaBio咨询公司政府事务部欧洲-美国区副总裁
分会场 T 5-4 | 2013年5月14日 星期二 15:30 - 17:30 二层, 201 b+c
中国与全球的疫苗产品认证和肝炎新疫苗研发
会议主持
史力 博士上海泽润生物科技有限公司首席执行官
提高疫苗产品质量及新型疫苗的开发正在中国得到更多的关注。向世界供应中国制造的疫苗已提上中国疫苗行业的议事日程。世卫组织预认证(PQ)和新版GMP的实施已经在中国实实在在地展开并取得了实际成果。肝炎疾病是亚洲包括中国最普遍和严重的疾病之一。本次会议将探讨WHO的PQ实践和肝炎疫苗的有效性及新发展。本次会议还将回顾开发创新生物医药产品与抗传染病产品开发的国际合作的机会。
世卫组织对疫苗和生物制品的质量预认证
nora deLLePiane 博士世界卫生组织基本药物和医疗产品部疫苗质量和监管组组长，质量安全科学家
滴定法检测甲型肝炎减毒活疫苗
汪萱怡 博士，教授上海复旦大学医学院
新二代乙型肝炎疫苗的开发：新型佐剂提高疫苗的有效性
Tyler J. MarTin 医学博士美国Dynavax总裁和首席医疗官
细胞治疗和生物类似药的开发机会和法规管理上的考虑
hoss dowLaT 博士德国PharmaBio咨询公司政府事务部欧洲-美国区副总裁
专题 6 | CMC
分会场 T 6-1 & T 6-2 | 2013年5月14日 星期二 08:30 - 12:00 二层, 201 D
仿制药与参比制剂之比较与评价 — 仿制药质量一致性评价
会议主持
桂敏 博士百时美施贵宝全球注册科学部 亚太区和中国CMC及运营部总监
陈琦琬 博士辉瑞全球CMC执行总监前美国FDA新药审评质量评估部副部长美国FDA同仁会国际部成员
国家食品药品监督管理总局(CFDA)2012年开始对2007年前批准的仿制药进行再评价。该项工作旨在确保药品的安全、有效和质量。如何科学有效地进行评价？监管部门和制药企业面临着哪些实际挑战？如何解决发现的问题？本专场将讨论仿制药再评价、分享生物等效性评价和体外溶出度试验的经验。
国家食品药品监督管理总局仿制药质量一致性评价工作程序
cFda注册司 讲者已邀请
参比制剂的选择及溶出度对比试验指南
张启明中国食品药品检定研究院研究员
美国药企对仿制药生物等效性和体外溶出度的研究
魏晓雄 医学博士美国Medpace临床药理部总监美国FDA同仁会国际部成员
体内体外相关性- 挑战与考量
deepak hegde 博士无锡药明康德有限公司配方研发部副总裁
专家讨论
分会场 T 6-3 | 2013年5月15日 星期三 08:30 - 10:00 二层, 201 D
中美植物药监管展望
会议主持
陈琦琬 博士辉瑞全球CMC执行总监前美国FDA新药审评质量评估部副部长美国FDA同仁会国际部成员
在美国，植物药依照其用途被划分为食品增强剂或药品来监管。美国FDA在2004年发布了关于植物药的指导意见，其涵盖了FDA对临床研究的不同阶段与新药申请前的CMC方面的建议。该建议使制药业和学术界得以开始药用植物制品的研究，并在2006年批准了第一例植物药品。本专场将简要回顾植物药品监管的历史，探讨美国在开发此类药品时所面临的挑战，并与中国长期以来在中药监管方面的经验做比较。
国家食品药品监督管总局(CFDA)对中药的监管要求
周跃华中国药品审评中心中药民族药药学部副部长
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中药产业前景
周俊杰 博士上海和记黄埔医药有限公司总经理
中药新药研发策略和研发实践
叶祖光 教授中国中医科学院首席研究员
中药全球化所面临的机遇和挑战
张迅 博士葛兰素史克(上海)医药研发有限公司副总裁, 全球天然产物事业部负责人
分会场 T 7-2 | 2013年5月14日 星期二 10:30 - 12:00 二层, 203 c
中药开发的案例分析与实践
会议主持
许俊才上海医药临床研究中心高级副总裁
本专场将通过案例分析讨论中药开发的经验和监管要求，也将讨论"如何制定中药临床评价的标准"。
中国的中药监管要求和进展
CFDA药品注册司 讲者已邀请
中国中药临床研究新进展
许俊才上海医药临床研究中心高级副总裁
专题 8 | 肿瘤靶向药物的研发 合作单位； 美中抗癌协会
分会场 T 8-1 | 2013年5月14日 星期二 13:30 - 15:00 二层, 201 D
肿瘤诊断和治疗模式的改变对药物研发的影响
会议主持
陈之键 医学博士，工商管理硕士阿斯利康(中国)全球药物研发 中国区副总裁兼负责人
徐莉 医学博士，工商管理硕士美国辉瑞公司肿瘤业务部， 肿瘤中国策略规划、贯彻和全球运作部副总裁
肿瘤靶向创新药物研发现状概述以及2个成功研发案例的回顾分析
概述和介绍
Jorge PUenTe 医学博士美国辉瑞公司肿瘤业务部 亚太区和加拿大区总裁
案例：基于标志物或靶点的抗肿瘤药物的研发-对合适的人群在合适的时间给予合适的药物
• 案例 1 - 克唑替尼：间变性淋巴瘤激酶(ALK)和非小细胞肺癌(NSCLC)
Maria koehLer 医学博士美国辉瑞公司肿瘤业务部，临床研究和医学事务部副总裁
• 案例 2 - 针对BRAF V600e/k 基因突变的黑色素瘤的BRAF抑制剂治疗
郭军 教授, 医学博士北京肿瘤医院、北京大学临床肿瘤学院副院长，北京市肿瘤防治研究所副所长，肾癌黑色素瘤内科主任
美国植物药的监管背景
吴笃恭 博士PPD法规部总监/资深顾问美国FDA同仁会国际部成员
美国植物药品开发所面临的监管挑战
林则全 博士生物医药咨询公司资深顾问美国FDA同仁会国际部成员
专家讨论
分会场 T 6-4 | 2013年5月15日 星期三 10:30 - 12:00 二层, 201 D
全球生物制药法规的发展 — CMC视角
会议主持
蔺亚萌罗氏(中国)技术监管政策部经理
桂敏 博士百时美施贵宝全球注册科学部 亚太区和中国CMC及运营部总监
过去的十几年中，新技术的发展与应用不断促进生物制药的研发变革。本专场将介绍全球生物制药产品法规的沿革，以及影响美国和欧盟监管框架的新监管理念，如贯穿生物制药产品生命周期的工艺验证以及CMC变更管理方案等。此外还将讨论新ICH Q11指南在生物制药产品原料药研发中的应用，并结合具体的案例讨论如何将平台工艺应用于生物制药的开发。
美国生物制药监管法规的沿革
徐砺新 医学博士美国FDA药品审评与研究中心单克隆抗体处，生物科技产品办公室，生物药品质量评审专家
ICHQ11指南在生物制药原料药研发中的应用
anthony ridgwaY 博士加拿大卫生部健康产品和食品局 生物和基因疗法处资深监管科学家
模块化病毒验证方法在单克隆抗体平台纯化工艺中的应用
陈琪 博士美国Genentech公司病毒清除室，蛋白纯化系副总监兼资深科学家
专题 7 | 传统中药 (TcM)
分会场 T 7-1 | 2013年5月14日 星期二 08:30 - 10:00 二层, 203 c
开发适用于中国及全球的创新性中药
会议主持
张迅 博士葛兰素史克(上海)医药研发有限公司副总裁, 全球天然产物事业部负责人
许俊才上海医药临床研究中心高级副总裁
本专场将介绍关于创新性中药产品开发的研发战略和方法，并将讨论制药企业致力于借鉴国际临床药物研发技术和标准，研发高质量、受专利保护以及临床证实的中药新药所面临的机遇和挑战。
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分会场 T 8-2 | 2013年5月14日 星期二 15:30 - 17:30 二层, 201 D
肿瘤靶向创新药物研发策略
会议主持
陈之键 医学博士, 工商管理硕士阿斯利康(中国)全球药物研发 中国区副总裁兼负责人
徐莉 医学博士，工商管理硕士美国辉瑞公司肿瘤业务部， 肿瘤中国策略规划、贯彻和全球运作部副总裁
讨论如何制定高质量、快速、有价值的肿瘤靶向药物开发和注册策略及中国从参与到主导研发的角色转变。
创新肿瘤靶点识别和验证
杨炜 博士强生中国上海研发中心研发科学事务部总监
临床研发策略：确定适当目标人群，采用最佳终点指标和研究设计，充分利用中国优势
牟骅 医学博士和记黄埔医药(上海)有限公司执行副总裁及首席医务官
中国在参与和领导肿瘤创新药物的发现和研发过程中的角色
周彩存 教授, 博士同济大学医学院肿瘤研究所所长，肿瘤学系主任
专题 9 | 药物毒理
分会场 T 9-1 | 2013年5月15日 星期三 08:30 - 10:00 二层, 201 b+c
药物毒理：从动物试验到人体试验
会议主持
龚兆龙 博士美国FDA同仁会国际部成员前美国FDA新药审评员北京莱博药业总经理
讨论新药开发中美国和中国FDA对临床前安全性评价的法规要求，临床前安全性数据的分析和解释，以及如何用动物数据预测人体的潜在风险和支持法规申报和决策。
美国FDA临床前安全评价要求
Paul a. andrewS 博士卫材公司全球法规事务部执行总监
中国CFDA临床前安全评价要求
彭健 博士赛诺菲(中国)亚太研发中心科学顾问
专家讨论
分会场 T 9-2 | 2013年5月15日 星期三 10:30 - 12:00 二层, 201 b+c
GLP法规；数据的质量和完整性
会议主持
姚大林 医学博士美国FDA同仁会国际部成员前美国FDA资深药审官，GLP督查官昭衍新药研究中心有限公司资深副总裁监首席科学家
从CRO和政府监管机构观点出发，全面阐释与GLP法规相关的临床数据的质量和完整性，终极目标是保证达到临床项目的安全。
非临床研究管理规范(GLP)的遵循问题对临床前研究的数据质量与完整性的影响 — 合同研究组织(CROs)的视角
Jane PearSe 博士英国亨廷顿生命科学公司国际市场部特殊项目总监
GLP法规和药物安全性评价对公众健康的重要意义 - FDA 的观念
姚大林 医学博士美国FDA同仁会国际部成员前美国FDA资深药审官，GLP督查官昭衍新药研究中心有限公司资深副总裁监首席科学家
专家讨论
以上讲者及
付立杰 博士, 美国毒理科学院院士SNBL中国事业总经理，中国毒理学会副理事长，亚洲毒理学会副会长
左从林 昭衍新药研究中心有限公司总裁兼CEO
分会场 T 9-3 | 2013年5月15日 星期三 13:30 - 15:00 二层, 201 b+c
药物研发的毒理评价和风险评估
会议主持
付立杰 博士, 美国毒理科学院院士中国事业总经理，中国毒理学会副理事长，亚洲毒理学会副会长
王英 博士, 美国认证毒理学家葛兰素史克中国研发中心药物安全评价总监
本专场讨论毒理学在药物研发中的安全评价和风险评估，着重于中国生物药和中药临床前安全评价，以及技术转让过程中非临床的风险评估。
毒理学的基本概念，危害与风险
付立杰 博士, 美国毒理科学院院士SNBL中国事业总经理，中国毒理学会副理事长，亚洲毒理学会副会长
干细胞治疗产品的安全性评价
马璟 医学博士 国家上海新药安全评价研究中心研究员
中药的安全性评价及案例研究
王全军 医学博士国家北京药物安全评价研究中心主任助理
化合物技术转让过程中非临床全性评估
王英 博士, 美国认证毒理学家葛兰素史克中国研发中心药物安全评价总监
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专题 10 | 数据管理和电子临床
分会场 T 10-1 | 2013年5月15日 星期三
08:30 - 10:00 二层, 201 a
科技进展对临床数据管理的影响
会议主持
刘川 博士Medidata Solution大中华地区发展总监
高新技术的发展也使临床研究领域发生变化，如临床试验方案制定和数据获得与交换方式方法的改变。临床研究在应用高新技术和信息的某些方面相对落后。因此了解云技术等高科技发展趋势及应用对推动制药业的发展非常重要。本专场将讨论高新技术给数据管理者带来的益处，及对今后数据管理领域的影响。
大数据运算 — 理念与实践
glen de vrieS美国Medidata Solutions公司总裁
生命科学领域的云技术应用
abhishek bagga印度Cognizant Technology Solutions生命科学研发部临床中心经理
生物信息工具在数据分析和管理中的应用
eric S. herbeL美国Integrated Clinical Systems公司总裁
专家讨论
分会场 T 10-2 | 2013年5月15日 星期三 10:30 - 12:00 二层, 201 a
安全数据管理 – 数据管理者的职责
会议主持
刘宗范默沙东研发(中国)有限公司 全球临床数据管理中心亚太区总监
本专场将介绍如何通过数据验证计划，数据审核过程和医学编码程序确保安全性数据的质量。经验丰富的讲者与参会者分享管理安全数据的经验，共同讨论如何应对安全数据管理的挑战。
安全数据的验证及严重不良事件的考虑
陈朝华辉瑞中国研发中心全球临床数据服务部负责人
I期临床研究的安全性数据管理
徐刚葛兰素史克(中国)研发数据管理部总监
安全数据管理-编码
Lobo Loo默沙东数据管理部中国区副总监
专家讨论
分会场 T 10-3 & T 10-4 | 2013年5月15日 星期三 13:30 - 17:30 二层, 201 a
数据标准在临床研究中的应用和成功案例
会议主持
张子豹 博士PPD生物统计与编程部副总监
邓亚中 工商管理硕士科文斯(中国)临床数据分析与报告负责人
数据标准一直是药物研发中优化临床研究及提升数据和信息流通水平的热门话题。本专场将集中研讨标准化带来的价值以及全球实施的不同方法。专家们将分享成功经验、讨论临床试验中采用数据标准化所遇到的挑战、及CDISC标准化实施及监管要求的最新动态。
从电子健康档案到临床数据库
demetris ZaMbaS美国默沙东全球数据管理部执行总监
一个全球CRO实施CDISC标准的经验
niklas MorTon美国PPD公司生物统计与编程部副总裁
应用CDISC标准的实例：从CDASH 到 SDTM 和 ADAM
吴崇胜 博士科文斯(中国)公司生物统计部资深经理
使用CDISC标准以提高临床研究的效率
Ivan Tjong-A-HUNG 医学博士，工商管理硕士上海霖谷医药科技有限公司总经理
CDISC标准在中国的最新进展
王兰香诺华制药(中国)有限公司综合信息科学部首席统计师中国CDISC协调委员会委员
专家讨论以上讲者及
黄钦 博士中国药品审评中心生物统计学部副部长
专题 11 | 医疗器械、药械组合产品的创新
分会场 T 11-1 & T 11-2 | 2013年5月15日 星期三 08:30 - 12:00 二层, 203 c
医疗器械的创新、监管及研发投资
会议主持
王凯玲上海瑞格律师事务所 中国生命科学首席顾问
王春燕 圣犹达医疗用品(香港)有限公司 亚太区临床研究总监
本专场将讨论医疗器械的创新、注册和资金支持。资深专家将介绍CFDA最新颁布的医疗器械GCP草案，审视风险投资在医疗器械创新和开发中所起的作用、并进行案例分析。
医疗器械创新
kok-hwee ng 博士圣犹达医疗用品有限公司 创新和策略制作中心设备研发部总监
46
中国医疗器械的GCP草案
cFda医疗器械监管司 讲者已邀请
优化医疗器械临床试验
宓现强 教授中国科学院上海高等研究院
医疗器械创新: 案例分析
王凯玲上海瑞格律师事务所 中国生命科学首席顾问
风险投资在医疗器械领域的作用
邢菲 医学博士中国德诚资本投资公司总监
专题 12 | 合同研究机构
分会场 T 12-1 | 2013年5月15日 星期三 13:30 - 15:00 二层, 201 D
如何建立双赢关系
会议主持
蒋皓媛 医学博士江苏恒瑞制药有限公司执行医疗总监
在药品/器械开发的过程中，企业可能不需要自行承担全部的研发工作。本场将重点讨论药企寻求外包合作伙伴的考评标准。除费用因素外，药企与CRO的沟通还包括具体业务要求，科学/医疗方面的专长，特殊领域的技术，定向职能的合作，甚至是外派专业人员，直至整个项目的外包合作。
案例介绍：如何利用中国收集的安全数据在美国成功地申报IND
李锡明 医学博士绿叶制药集团全球临床研究和监管事务部副总裁
药物早期临床研究: CRO的选择及协作的机会
吴安凡 博士罗氏中国早期开发部负责人
案例分析: 企业与CRO合作成功在美国申报IND
王在琪 医学博士中国默沙东临床研究执行总监
合作中共赢共生
蒋皓媛 医学博士江苏恒瑞制药有限公司执行医疗总监
分会场 T 12-2 | 2013年5月15日 星期三 15:30 - 17:30 二层, 201 D
合同研究机构对确保药品安全所起的作用
会议主持
宫岩华中国医药市场协会副理事长，中国医药技术市场协会CRO联合体副主席兼秘书长， 新药创新和专业化委员会常务副主任
刘佳爱恩希(北京)医疗科技有限公司 北亚及中国区总经理
本专场将重点探讨合同研究机构如何通过创建合理优化的内部组织结构和发展在中国的高质量团队来保证研究中病人安全。
在临床试验实施中支持患者安全管理的药物警戒战略同盟
Sheona STevenSon 博士新加坡INC Research药物警戒部副总监，亚洲区负责人
中国的临床监查: CRO视角下的质量保证
陈丽娟InVentiv Health Clinical 公司 临床研究中心亚太区执行总监
一个中国本土CRO公司在IPO上市后的业务发展
沙伟郡杭州泰格医药 事业发展部总监兼项目总监
专家讨论组
以上讲者
专题 13 | 上市后和实际环境中的药物研究
分会场 T 13-1 | 2013年5月15日 星期三 15:30 - 17:30 二层, 201 b+c
上市后和实际环境中的药物研究
会议主持
张丹仪 医学博士上海华斯泰生命策略研究所 公司创立者及首席医疗官
一个药品批准上市后，科学和医学研究仍在继续。有许多方法和机制可用于在实际环境中进一步研究和评价该药物的安全与有效性，并发现其潜在的新用途。本专场将围绕这些方法在国内的应用趋势、实用性、问题和其可能的解决办法进行讨论。
引言和概述
张丹仪 医学博士上海华斯泰生命策略研究所 公司创立者及首席医疗官
病人登记
萧燕 医学博士罗氏(中国)药物研发亚太区中心高级流行病学家
临床研究者启动的试验
• 案例 I
范帆 博士赛诺菲(中国)资深医疗总监
• 案例 II
王伊龙 博士北京天坛医院神经内科，科研处副处长
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专题 14 | 药物流行病学的最佳实践和药物安全
分会场 T 14-1 | 2013年5月15日 星期三 13:30 - 15:00 二层, 203 c
药物流行病学的最佳实践和药物安全
会议主持
周伟 医学博士默沙东默克实验室 流行病学亚太区总监
本专场邀请来自学术界、政府监管部门、及药业著名的药物流行病学家分享对药物流行病的研究现状、最新进展及比较效益分析的见解。
药物研发和风险控制中药物流行病学基本原理及方法介绍
詹思延 教授, 医学博士北京大学医学部 流行病和生物统计系副主任
药物流行病及药物安全监管法规的进展
cFda安监司 讲者已邀请
药物流行病研究的最新进展：电子医疗及保险数据库，及比较效益分析在评价药物安全和有效性中的应用
陈建炜 博士台湾大学医院 医学研究科副主任
专题 15 | 中国药品电子监管
分会场 T 15-1 | 2013年5月15日 星期三 15:30 - 16:15 二层, 203 c
药品追溯体系建设 – 药品电子监管
王迎利 国家食品药品监督管理总局 信息中心信息规划处副处长
DIA eLearningEasy Access to Instant Education
• Flexibility to Learn Anytime, Anywhere
• Reduce Travel Costs
• Self-Paced Programs
Visit diahome.org/elearning.
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SUndaY, MaY 12, 2013 | PreconFerence workShoPS onLY
07:30-16:00 1st Floor, Foyer Registration
08:30-17:30 2nd Floor, 201B Full-Day Workshop 1 Analysis of Data Patterns to Monitor and Assess Outcomes of Clinical Studies
2nd Floor, 201C Full-Day Workshop 2 Drug Substance and Drug Product Stability Requirements and Practices
2nd Floor, 201D Full-Day Workshop 3 Data Management for Oncology Trials
2nd Floor, 203C Full-Day Workshop 4 Applying MedDRA in Clinical Safety and Pharmacovigilance Practices: Regulatory Perspective
2nd Floor, 201A Full-Day Workshop 5 Global Clinical Trials in Drug Development-Principles and Case Studies 3rd Floor, 307 Full-Day Workshop 6 National Drug Safety and Active Pharmaceutical Ingredients (APIs) in China: Development of Recommendations for the Regulation of APIs
10:00-10:30 1st Floor, Exhibition Hall Tea Break
12:00-13:00 2nd Floor, Conference Hall 2 Lunch
15:00-15:30 1st Floor, Exhibition Hall Tea Break
MondaY, MaY 13, 2013 | conFerence daY 1
07:30-16:00 1st Floor, Foyer Registration
13:30-17:30 1st Floor, Exhibition Hall Exhibition Open
13:30-17:30 2nd Floor, Conference Hall 1 Opening Plenary Session
15:00-15:30 1st Floor, Exhibition Hall Tea Break
15:30-17:30 2nd Floor, Conference Hall 1 Keynote Speech
encoUrage drUg innovaTion and enSUre PaTienT SaFeTY Professor guowei Sang, Md President, Chinese Pharmaceutical Association (CPA) Academician, Chinese Academy of Engineering
riSk ManageMenT PLanning SPUrS innovaTion and enabLeS PaTienT SaFeTY Patrizia a. cavaZZoni, Md Senior Vice President, Worldwide Safety and Established Products Regulatory, Pfizer Inc. USA
STaTUS and eXPecTaTionS aboUT arv TreaTMenT For PeoPLe Living wiTh hiv Lin Meng Director, Ark of Love Information Center General Secretary of China Alliance of People Living with HIV/AIDS Representative of Country Coordinating Mechanism (CCM) of the Global Fund China Programs
17:30-19:30 1st Floor, Exhibition Hall/2nd Floor, Conference Hall 2
Welcome Reception - China Night: DIA China 5th Anniversary Celebration
TUeSdaY, MaY 14, 2013 | conFerence daY 2
07:30-16:00 1st Floor, Foyer Registration
08:30-17:30 1st Floor, Exhibition Hall Exhibition Open
08:30-10:00 1st Floor, 5 C+F T 1-1 Clinical Excellence When Involving China in Global Clinical Development: Maximize Benefits and Minimize Risks 1st Floor, 5 A+B+G+H T 2-1 Global Trends and China Development Status on Fixed-dose Combinations (FDCs) 1st Floor, 5 D+E T 3-1 Pharmacovigilance during Pre-approval – An Exciting Journey of Investigation 2nd Floor, 201 A T 4-1 Safety Signal Detection and Quantitative Assessment of Benefit/Risk Ratio- Part I 2nd Floor, 201 B+C T 5-1 Ensuring Innovation and Safety for Cell/Gene Therapy and Blood Products 2nd Floor, 201 D T 6-1 Evaluation of Generic Products vs. Reference Products - The 2007 Conundrum - Part I 2nd Floor, 203 C T 7-1 Development of Novel TCM Products for China and Global Market
10:00-10:30 1st Floor, Exhibition Hall Tea Break
10:30-12:00 1st Floor, 5 C+F T 1-2 Coordination and Communication among Stakeholders of Clinical Trials 1st Floor, 5 A+B+G+H T 2-2 New Biosimilar Regulation: Challenges and Opportunities 1st Floor, 5 D+E T 3-2 Pharmacovigilance during Post-approval - Path to Success 2nd Floor, 201 A T 4-2 Safety Signal Detection and Quantitative Assessment of Benefit/Risk Ratio- Part II
knowledge networking Meeting information
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knowledge networking Meeting information
2nd Floor, 201 B+C T 5-2 Principles for Pandemic Influenza Preparedness and Post-marketing Vaccine Manufacturing Changes 2nd Floor, 201 D T 6-2 Evaluation of Generic Products vs. Reference Products - The 2007 Conundrum - Part II 2nd Floor, 203 C T 7-2 Case Studies and Good Practices in TCM Development
12:00-13:30 2nd Floor, Conference Hall 1 Lunch
TUeSdaY, MaY 14, 2013 | conFerence daY 2 (continued)
13:30-15:00 1st Floor, Conference Hall 3 CFDA Townhall: Pre-marketing and Post-marketing Drug Safety Supervision in China 2nd Floor, 201 B+C T 5-3 Cell Therapy and Biosimilar Development, Opportunities, and Regulatory Considerations 2nd Floor, 201 D T 8-1 Changing Paradigm in Cancer Diagnosis and Treatment - Impact on Drug Development
15:00-15:30 1st Floor, Exhibition Hall Tea Break
15:30-17:30 1st Floor, Conference Hall 3 CFDA Townhall (continued) : Pre-marketing and Post-marketing Drug Safety Supervision in China 2nd Floor, 201 B+C T 5-4 Vaccine Product Qualification and Novel Hepatitis Vaccine Development for China and the World 2nd Floor, 201 D T 8-2 Strategies for Discovery and Development of Target-based Novel Cancer Medicines
17:30-19:30 2nd Floor, Conference Hall 2 Speaker & VIP Reception
wedneSdaY, MaY 15, 2013 | conFerence daY 3
07:30-16:00 1st Floor, Foyer Registration
08:30-17:30 1st Floor, Exhibition Hall Exhibition Open
08:30-10:00 1st Floor, 5 C+F T 1-3 GCP Clinics 1st Floor, 5 A+B+G+H T 2-3 & T 3-3 Balancing Risk and Benefit during IND Period 1st Floor, 5 D+E T 4-3 Overview of Meta - Analysis and Its Application in Drug Development 2nd Floor, 201 D T 6-3 Regulatory Perspectives on Botanical Drug Products in China and the United States 2nd Floor, 201 B+C T 9-1 Pharm/Tox: From Animal to Human 2nd Floor, 201 A T 10-1 Technology Advancement in the Landscape of Clinical Data Management 2nd Floor, 203C T 11-1 Medical Devices: Innovation, Regulation and Investment - Part I
10:00-10:30 1st Floor, Exhibition Hall Tea Break
10:30 - 12:00 1st Floor, 5 C+F T 1-4 Pharmacovigilance - QA Perspective 1st Floor, 5 A+B+G+H T 2-4 & T 3-4 Balancing Risk and Benefit during NDA and Post-marketing Periods 1st Floor, 5 D+E T 4-4 Quantitative Sciences in Pharmaceutical Development (QSPD) 2nd Floor, 201 D T 6-4 Evolution of Global Biotherapeutic Regulations – A CMC Perspective 2nd Floor, 201 B+C T 9-2 GLP Regulatory Compliance for Data Quality and Integrity 2nd Floor, 201 A T 10-2 Data Managers' Roles in Drug Safety
2nd Floor, 203C T 11-2 Medical Devices: Innovation, Regulation and Investment - Part II
12:00 - 13:30 2nd Floor, Conference Hall 1 Lunch / DIA Community Networking
13:30 - 15:00 1st Floor, 5 C+F T 1-5 Challenges and Opportunities at Clinical Trial Sites/Institutions 1st Floor, 5 A+B+G+H T 2-5 Therapeutic Biologic Development in China from CMC Perspective 1st Floor, 5 D+E T 3-5 Benefit-Risk: Getting It Right for Patients
2nd Floor, 201 D T 12-1 How to Build Win-Win Relationship
2nd Floor, 201 B+C T 9-3 Patient Safety: Toxicological Evaluation and Risk Assessment in Pharmaceutical R&D
2nd Floor, 201 A T 10-3 Data Standards in Real World Clinical Research - Part I
2nd Floor, 203C T 14 Pharmacoepidemiology - Drug Safety and Best Practices
15:30 - 17:30 1st Floor, 5 C+F T 1-6 Ethics Committee Roles and Development in China 1st Floor, 5 A+B+G+H T 2-6 Implementation of an Innovative Labeling Hub in Asia and Integration with Global Model 1st Floor, 5 D+E T 3-6 Does Risk Management Planning Benefit Patients? 2nd Floor, 201 D T 12-2 CRO: Value-added Taskforce to Ensure Patient Safety 2nd Floor, 201 B+C T 13 Post-approval and Real World Studies 2nd Floor, 201 A T 10-4 Data Standards in Real World Clinical Research - Part II 15:30 - 16:15 2nd Floor, 203C T 15 Introduction of Drug Electronic Administration
The 5th DIA China Annual Meeting with the theme of “Patient Safety – A
Sustained Focus from Scientific Ideas to Innovative Medicines” will be held at the
Beijing International Convention Center from May 12 to 15, 2013. The meeting
is co-sponsored by the China Center for Pharmaceutical International Exchange
(CCPIE) of the China Food and Drug Administration (CFDA).
The Annual Meeting is the largest meeting held by DIA in the Asia Pacific re-
gion, featuring 15 themes with more than 40 sessions and 60 exhibits and bringing
together about 1000 professionals from the pharmaceutical and biopharmaceuti-
cal industries, contract research and service organizations, regulatory agencies,
and academic institutes on a neutral global platform. The program includes the
plenary and parallel sessions, preconference workshops, panel discussions, scien-
tific posters, exhibitions, networking opportunities, and more. Attendees will share
knowledge and experience focusing on better public health protection, patient
benefits, risk management, best practices and compliance in alignment with sci-
ence and regulations.
5th dia china annUaL MeeTing
PrograM vice chair
6th dia china annUaL MeeTing
PrograM co-chair
5th dia china annUaL MeeTing
PrograM co-chairS
Lingshi TAN, PhDgeneral manager, pfizer (china) r&D co. ltd.Vice president, pfizer Worldwide Development operations, china
Yajun ZHAODirector-general, china center for pharmaceutical International exchange (ccpIe), china
Dayao ZHAO, MD, PhDhead of china r&D and scientific affairs, Vice president, Janssen pharmaceutical r&D, Johnson & Johnson, china
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full-Day
08:30-17:30 analysis of Data patterns to monitor and assess outcomes of clinical studies
08:30-17:30 Drug substance and Drug product stability requirements and practices
08:30-17:30 Data management for oncology trials
08:30-17:30 applying medDra in clinical safety and pharmacovigilance practices: regulatory perspective
08:30-17:30 global clinical trials in Drug Development - principles and case studies
08:30-17:30 national Drug safety and active pharmaceutical Ingredients (apIs) in china: Development of recommendations for the regulation of apIs
the system.• To learn approaches for enhancing clinical R&D efficiency and quality• To master transforming data to knowledge for better resource allocation
and risk-based decision making• To learn the usage of the global dictionaries for coding of clinical trial and
safety data
TArgeTeD AuDIeNCe
Professionals in the following areas:• Clinical management and operation• Clinical IT and computing • Clinical trial data monitoring (CRAs, medical monitoring)• Data assurance and data quality control• Clinical informatics• Regulatory affairs • Data management and programming• E-clinical vendor management• Drug research and development
AgeNDA
SeSSion i | bioinformatic Tools in the Management of clinical Studies i
• Data review during the discovery phase
SeSSion ii | bioinformatic Tools in the Management of clinical Studies ii
• Quality review process • Patient data tracking • CDISC standard data structures and approaches
SeSSion iii | advanced reporting and analysis to drive clinical development efficiencies
• Clinical R&D efficiency and quality• Allocation of resources• Studies planning and decision making
SeSSion iv | effective data Management and knowledge discovery on global data – the UMc Perspective i
• Signal detection and other methods for knowledge discovery• Transforming data to knowledge: the importance of consistent dictionaries
and terminologies
SeSSion v | effective data Management and knowledge discovery on global data – the UMc Perspective ii
• Use of the WHO Drug Dictionaries for coding of clinical trial and safety data
workshop 108:30 - 17:30 (12:00 - 13:00 lunch) 2nd floor, 201 b
anaLYSiS oF daTa PaTTernS To MoniTor and aSSeSS oUTcoMeS oF cLinicaL STUdieS
INSTruCTOrS
daniel LiU, Phd Director, China Development, Medidata Solutions Worldwide, China
eric S. herbeLPresident, Integrated Clinical Systems, Inc., USA
Yutaka SaToBusiness Consultant, Solutions Architecture, Medidata Solutions, Japan
Madeleine krieg, rPhProduct Manager,Uppsala Monitoring Centre, Sweden
Maria LindqUiST, Phd Director & CEO,Uppsala Monitoring Centre, Sweden
DeSCrIPTION
Over the past 10 years, the duration and complexity of clinical trials have steadily increased, Pharmaceutical R&D budgets are tighten and less resources on longer and more complex clinical trials have been observed. It becomes more critical to conduct clinical trials with more effective and innovative approaches. This workshop will discuss typical use patterns and best practices for data analysis of clinical studies. Topics include use patterns in support of ongoing medical monitor of clinical trials, use of CDISC data structure for risk-based monitoring, trial management during a clinical trial and post-approval clinical activities. A variety of approaches for reviewing clinical data, study planning, and decision-making based on the data accumulation will be discussed. The workshop will also cover topics such as a better allocation of resources to enhance clinical R&D efficiency and quality, benefits for patient data review, methods for outlier detection, and how to conduct signal detection.
LeArNINg ObjeCTIveS
• To understand when and how to use bioinformatic tools in reviewing clinical data.
• To learn typical use patterns that have emerged focusing on the “patient identification/drill-down” reports, graphs, patient profile interactions of
SUNDAY, MAY 12, 2013 | PRECONFERENCE WORKSHOPS ONLY
52
workshop 208:30 - 17:30 (12:00 - 13:00 lunch) 2nd floor, 201 c
drUg SUbSTance and drUg ProdUcT STabiLiTY reqUireMenTS and PracTiceS
INSTruCTOrS
Joan rUan, PhdAssociate Director, Analytical Development Bristol Myers Squibb Co, USA
Xin (amy) bU, PhdPrincipal Scientist, Analytical and Bioanalytical Development Bristol Myers Squibb Co, USA
DeSCrIPTION
Stability is a crucial quality attribute of pharmaceutical products; therefore, a stability program in compliance with current regulations is critical to all the phases of the drug development process and the new pharmaceutical product registration. Successful execution of stability programs requires a good understanding of global regulatory requirements, stability methodologies, and best practices. This session presents a comprehensive overview of FDA, ICH and WHO stability requirements for pharmaceutical products including regulatory and technical aspects to design global stability programs, which are cost effective and in compliance.
LeArNINg ObjeCTIveS
• To understand stability role in the drug development process• To design stability study based on ICH/WHO and global requirements• To execute global stability program effectively• To understand the importance of stability indicating methods• To manage global technology transfer• To interpret stability data
TArgeTeD AuDIeNCe
• Pharmaceutical R&D scientists and managers • Regulatory affairs staff• Quality assurance and quality control professionals• Contract Research/Manufacturing Organization• Government health authority• Academic institution
AgeNDA
SeSSion i | overview of critical regulatory requirements for drug Stability Program
• Stability role in the drug development process • Review of cGMP stability requirements• Review of ICH guidelines for stability• Requirements for global stability programs• Assignment of drug product shelf-life
SeSSion ii | Practice in Technical aspects of drug Stability
• Development of stability indicating methods• Design of forced degradation studies• Method validation and transfer• Evaluation of stability data
SeSSion iii | discussion - case Study
workshop 308:30 - 17:30 (12:00 - 13:00 lunch) 2nd floor, 201 D
daTa ManageMenT For oncoLogY TriaLS
INSTruCTOrS
charles Yan, PhdTechnical Operations Lead, Clinical Data Services, Pfizer (China) R&D Center, China
Li XU, Md, MSd, MbaVice President, Oncology Strategy, Implementation, and Oncology Operations,Oncology Business Unit, Pfizer, USA
emily TanExecutive Director, Clinical Research Asia Pacific,InVentiv Health Clinical, Singapore
wei Zhang, MdTA Lead, CDS, Pfizer (China) R&D Center, China
Shuling wUData Management TA Lead,Pfizer (China) R&D Center, China
Juan wangData Manger, Oncology Group, CDS,Pfizer (China) R&D Center, China
kiki wU Associate Director, Clinical Data Management, MSD R&D (China), China
DeSCrIPTION
The full day workshop consists of two sessions: session I (basic) will introduce the fundamentals for professionals new to oncology clinical trials and session II (advanced) will focus on the data management activities at each phase of oncology trials.
LeArNINg ObjeCTIveS
• To introduce the basics in cancer definition, diagnosis/treatment, and the stages of oncology trials.
• To specify the characteristics for an oncology trial in design, efficacy endpoints, and safety monitoring.
• To understand data management activities at each phase of the oncology trials by focusing on CRF design, data cleaning, lab data handling, response data measurement, and long-term study management.
• To discuss the best practices in oncology trials regarding the key data points, SAE handling, and lab data review.
TArgeTeD AuDIeNCe
This workshop is designed for clinical professionals who are new in oncology trials or new in oncology data management. It will also benefit the following professionals:• Clinical researchers• Trial project managers• Trial monitors• Biostatisticians• Trial programmers
AgeNDA
SeSSion i | oncology clinical Trial basics Part i : overview
• Drug Development• Oncology Standards of Care and Related Terminology
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Part ii : Trial design and endpoints
• Phases and Types of Oncology Trials• Endpoints (PFS, ORR, OS, RECIST 1.1)
Part iii : Trial conduction
• Informed Consent• Site Monitoring and Protocol Deviation
Part iv : Safety Monitoring
• Adverse Events and Serious Adverse Events• Common Terminology Criteria for Adverse Events (CTCAE)
Part v : case Study
SeSSion ii | basics for oncology data Manager
Part i : Study initiation
• Understanding CRF design and database building for oncology trials• Understanding treatment cycle for oncology studies• Understanding efficacy data collection and measurement
Part ii : Study execution
• Cleaning response data from oncology studies• Handling local lab data with normal ranges• Understanding/supporting clinical review on response and toxicity data• 3rd Party review, challenges to DM• Handling external data with reconciliation
Part iii : Study completion
• Database lock for interim analysis for ongoing oncology studies• Managing long-term studies with follow-up
Part iv : best Practices for oncology Trials
• Critical data points in oncology trials• Data collection: needs vs. nice to have• SAE handling• Panic lab test data review• Tumor response
workshop 408:30 - 17:30 (12:00 - 13:00 lunch) 2nd floor, 203 c
aPPLYing Meddra in cLinicaL SaFeTY and PharMacovigiLance PracTiceS: regULaTorY PerSPecTive
INSTruCTOrS
anna Zhao-wong, Md, Phd, PMPDeputy Director, MedDRA Maintenance and Support Services Organization, USA
Sonja braJovic, MdMedDRA Coordinator, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research (CDER), FDA, USA
DeSCrIPTION
This workshop will focus on the application of MedDRA in clinical safety and pharmacovigilance, including a regulatory perspective. It will provide in-depth coverage of how to consistently and accurately encode clinical data with MedDRA and options to retrieve and present MedDRA-coded data as outlined in the ICH-endorsed “MedDRA Term Selection: Points to Consider” and “MedDRA Data Retrieval and Presentation: Points to Consider” documents. The use of Standardised MedDRA Queries (SMQs) as tools to aid case identification and signal detection will be discussed. The implementation of MedDRA in US FDA Adverse Event Reporting System (FAERS) database will be described,
including the current use of the terminology for coding and analysis of safety data. Attendees are encouraged to bring questions about MedDRA coding, data retrieval/analysis to share and discuss.
LeArNINg ObjeCTIveS
• To describe the use of MedDRA terminology in coding adverse event data. • To demonstrate strategies for retrieval and subsequent analysis of
MedDRA-coded data in clinical safety and pharmacovigilance.• To understand how US FDA applies MedDRA in post-market
pharmacovigilance utilizing the FDA Adverse Event Reporting System (FAERS) and in analysis of clinical trial safety data in new drug review.
TArgeTeD AuDIeNCe
This workshop is designed for the following professionals who already have a basic knowledge of MedDRA and wish to explore the implications of its use in clinical safety and pharmacovigilance: • Pharmacovigilance and clinical research professionals• Clinical data managers• Medical writers • Regulatory affairs professionals
AgeNDA
SeSSion i | Meddra introduction
SeSSion ii | Meddra coding and the ich-endorsed coding guide: "Meddra Term Selection: Points to consider "
• Overview of MedDRA coding and the “MedDRA Term Selection: Points to Consider” document
• Data quality issues from US FDA perspective with coding examples • Coding exercises• Question & Answer
SeSSion iii | analyzing Meddra-coded data and the ich-endorsed data retrieval guide: "Meddra data retrieval and Presentation: Points to consider"
• Overview of the “MedDRA Data Retrieval and Presentation: Points to Consider” document
• Developing queries using MedDRA• Query development exercise• Standardised MedDRA queries• Customized searches• FDA approach to MedDRA search strategies for signal detection: examples
from FDA AERS database and new drug safety review • Question & Answer
SeSSion iv | Meddra versioning
workshop 508:30 - 17:30 (12:00 - 13:00 lunch) 2nd floor, 201 a
gLobaL cLinicaL TriaLS in drUg deveLoPMenT – PrinciPLeS and caSe STUdieS
INSTruCTOrS
william wang, PhdSite Head and Executive Director, Biostatistics and Research Decision Sciences - Asia Pacific (BARDS-AP)Merck Research Laboratories / MSD R&D (China) Co. Ltd., China
qiong ShoU, PhdSenior Scientist, Biostatistics and Research Decision Sciences - Asia Pacific (BARDS-AP)Merck Research Laboratories / MSD R&D (China) Co. Ltd., China
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hsien-Ming James hUng, PhdDirector, Division of Biometrics I, Office of Biostatistics OTS , Center for Drug Evaluation and Research (CDER), FDA, USA
Sue-Jane wang, PhdAssociate Director, Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research (CDER), FDA, USA
Yuki andoSenior Scientist, Biostatistics Group, Center for Product Evaluation, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
DeSCrIPTION
In recent years, there was a significant increase of global clinical trials in pharmaceutical development. ICH guidance and/or local regulatory guidelines have set the basic scientific principles. The purpose of this workshop is to show the regulatory, statistical, clinical and operational principles through case studies in Cardiovascular (CV), Central Neurological System (CNS), anti-infective, oncology, and other therapeutic areas that may involve genomic factors. In each case study we will illustrate the disease, typical trial design, global development strategies, the global or regional clinical trial results, and regulatory review considerations.
LeArNINg ObjeCTIveS
• To review the regulatory, statistical, clinical and operational principles in global clinical trials.
• To learn various clinical development strategies for registration with different regulatory agencies through case studies.
• To review regulatory guidelines for regional registration through case studies.
TArgeTeD AuDIeNCe
Professionals working in the following areas: • Quantitative science • Regulatory affairs• Pharmaceutical industry (preclinical, pre-market, post-market
development)• Contract Research Organizations (CROs)• Government organizations • Academia and research institutes
AgeNDA
SeSSion i | Principle and case examples in the cv/cnS areas
• Concepts of consistency and inconsistency (e.g. PLATO – acute coronary syndrome trial, and schizophrenia trials)
• Challenges and advantages of global versus regional trial strategy
SeSSion ii | Principles and case examples in global/regional Pharmacogenomics Trials
• Special features in design and analysis of pharmacogenomics trials (e.g. cancer, anti-viral, and other drug development influenced by genomic factors)
• Challenges versus advantages in global versus regional pharmacogenomics
SeSSion iii | Principles and case examples in global/asian clinical Trials
• Development strategy and selection of trial design - Global/Asian/Regional
• Evaluation of overall and regional results in global clinical trials
SeSSion iv | Panel discussion
workshop 608:30 - 17:30 (12:00 - 13:00 lunch) 3rd floor, 307
naTionaL drUg SaFeTY and acTive PharMaceUTicaL ingredienTS(aPis) in china: deveLoPMenT oF recoMMendaTionS For The regULaTion oF aPis
WeLCOMe reMArkS
cFda official invited
Ling SU, Phdpresident, DIa board of Directorsstrategic advisor, life sciences, sidley austin llp, china
nicole Taylor SMiTh, Jdassistant country Director, u.s. fDa, china office
SeSSION i | Summary of the 2012 roundtable discussion on the regulation of aPis and cooperation
Jeffrey grenDirector, office of health and consumer goods, u.s. Department of commerce, u.s. co-chair of Jcct pharmaceuticals task force, usa
SeSSION ii | definition and regulation of aPis and chemical Manufacturing in the US and eU and the role of aPis in global drug Safety
Discussion on the new eu apI certification requirements and opportunities for international cooperation.
nicole Taylor SMiTh, Jdassistant country Director, u.s. fDa china office
Patrizia ToSeTTi, Phdpolicy officer, Dg health and consumers, european commission, france
SeSSion iii | industry Perspectives on the regulation of aPis
guy viLLaXchief executive, hoVIone, representative of rx-360, portugal
gary gUgeneral manager, Dsm sinochem pharmaceutical(Zibo) co., ltd, china
SeSSion iv | current Scope and regulation of aPis in china, and enforcement approaches to ensure compliance
the session will discuss the regulation and oversight of apIs and bulk chemical manufacturers in china.
CFDA Speaker Invited
SeSSion v | inspection of aPi Manufacturing Facilities and enforcement cooperation to address Unregulated bulk chemicals
Piotr kraUZescientific administrator, Inspections at european medicines agency, united Kingdom
gang wang, Phdassistant country Director, u.s. fDa china office
SeSSion vi | role of Pharmacopeias related to aPis in china, eU and US
china Pharmacopeial commission Speaker invited
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regIstratIon open
07:30 - 16:00
openIng plenary sessIon
13:30 - 17:30 2nd Floor, Conference Hall 1
openIng remarKs
Ling SU, Phdpresident, DIa board of Directorsstrategic advisor, life sciences, sidley austin llp, china
aWarDs ceremony
Welcome aDDresses
Lingshi Tan, PhdVice president, pfizer Worldwide Development operations;general manager, pfizer (china) r&D co. ltd., china
Yajun ZhaoDirector-general, china center for pharmaceutical International exchange (ccpIe), china
tea breaK
15:00 - 15:30
Keynote speech
15:30 - 17:30
Professor guowei Sang, Mdpresident, chinese pharmaceutical association (cpa)academician, chinese academy of engineering
Patrizia a. cavaZZoni, Mdsenior Vice president, Worldwide safety and established products regulatory, pfizer Inc. usa
Lin MengDirector, ark of love Information center,general secretary of china alliance of people living with hIV/aIDsrepresentative of country coordinating mechanism (ccm) of the global fund china programs
Welcome receptIon-chIna nIght: DIa china 5th anniversary celebration
17:30 - 19:30 Exhibition Hall & Conference Hall 2
Susanne keiTeL, PhdDirector general, council of europe, europe Directorate for Quality of medicines (eDQm), france
John hU, PhdVice president and general manager, us pharmacopeia, china
SeSSion vii | Legal and Policy considerations to ensure the quality of aPis and Prevent the Sale or export of Unregulated or Falsified aPis
Discussion and recommendations to prohibit and deter the manufacture and sale of unregulated bulk chemicals for use in pharmaceutical products, including potential suggestions for revisions to china’s Drug administration law, criminal code, and other statutes and regulations.
chen Yang, LLMpartner, sidley austin law office, china
Zhiwei LiUprofessor, beijing normal university, china
SeSSion viii | development of Specific Legal and Policy recommend-ations
to address the manufacturing, sale and distribution of unregulated or counterfeit/falsified apIs that are intended for use as an apI in a finished drug product that either originates from or is consumed in china.
OPeN DISCuSSION:
ModeraTorS:
Jeffrey grenDirector, office of health and consumer goods, us Department of commerce, usa
CFDA Speaker Invited
SeSSion iX | Future cooperation on the implementation of recommendations
SeSSion X | next Steps
CFDA Townhall
Tuesday, May 14, 201313:30 - 17:30 1st Floor, Conference Hall 3
Pre-MarkeTing and PoST-MarkeTing drUg SaFeTY SUPerviSion in china
2012 Drug Review and Evaluation in China
Zhen chen, PhdDeputy Office Director, Office of New Drug Pharmaceutical Science,CDE, CFDA, China
CFDA Speakers Invited
monDay, may 13, 2013 | conference Day 1
tuesDay, may 14, 2013 | conference Day 2
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Panelists
benny chung-Ying Zee, Professor, PhdDirector, Division of Biostatistics, School of Public Health and Primary Care, Center of Clinical Trial, The Chinese University of Hong Kong, China
Shuting Li, MdDirector, GCP Center, The Cancer Hospital of Chinese Academy of Medical Sciences, China
vivian gUSenior Director, Clinical Operations, Bristol-Myers Squibb, China
Li chen, MdHead of Project Manager, ICON, China
Session T 1-3 | wednesday, May 15, 201308:30 - 10:00 1st Floor, 5 C+F
gcP cLinicS
session Co-Chairs
hannah chen, MdDirector, CQA/PV China, Jansen Pharm R&D QA, Johnson & Johnson, China
Shuting Li, MdDirector, GCP Center, The Cancer Hospital of Chinese Academy of Medical Sciences, China
roUnd-TabLe diScUSSion
GCP/ Quality issues that are commonly seen in clinical research will be discussed in this section. Experts from all parties involved in clinical research will provide insights and opinions, aiming to get a better understanding among stakeholders involved in clinical research and to facilitate future quality improvement.
Panelists
Shuting Li, MdDirector, GCP Center, The Cancer Hospital of Chinese Academy of Medical Sciences, China
Paul dai, MdSenior Director, Regional Head of ICRO, AMAC, Greater China Region, Beijing Novartis Pharma Co. Ltd., China
Xueying wUHead of Clinical Development and Operations, Pfizer Medical, China
helen Li, MdDirector, Emerging Market QA Asia Lead, Pfizer Medical Quality Assurance, China
cFda department of drug registration Panelist invited
Session T 1-4 | wednesday, May 15, 201310:30 - 12:00 1st Floor, 5 C+F
PharMacovigiLance - qa PerSPecTive
session Chair
helen Li, MdDirector, Emerging Market QA Asia Lead, Pfizer Medical Quality Assurance, China
Theme 1 | Clinical research & Operations
Session T 1-1 | Tuesday, May 14, 201308:30 - 10:00 1st Floor, 5 C+F
cLinicaL eXceLLence when invoLving china in gLobaL cLinicaL deveLoPMenT: MaXiMiZe beneFiTS and MiniMiZe riSkS
session Chair
vivian gUSenior Director, Clinical Operations, Bristol-Myers Squibb, China
To ensure the successful operations of clinical trials, we need to identify critical success factors and focus on patient safety and risk management. These are of great interests to pharma companies as well as authorities. After FDA and EMA issued the guidance of risk based monitoring, the principles need to be applied also in China and Asian countries that are more actively involving in global clinical development simultaneously. The in-depth presentations and discussions in this section will provide audience guidance to archive the clinical excellence.
Critical Success Factors in Clinical Trials
Jong ran kiMVice President, Clinical Research of Asia Pacific, ICON, South Korea
Risk-Based Monitoring
elaine hawkingSExecutive Director, Regional Clincal Operations of Asia Pacific, Bristol-Myers Squibb, China
Risk and Benefit When Involving China and Asia in Global Clinical Trials
koichi MiYaZaki, rPhAssociate Director, Clinical Operation, Daiichi Sankyo, Japan
PaneL diScUSSion
Session T 1-2 | Tuesday, May 14, 201310:30 - 12:00 1st Floor, 5 C+F
coordinaTion and coMMUnicaTion aMong STakehoLderS oF cLinicaL TriaLS
session Chair
Yan wU, MdGeneral Manager, Division of Medical and Drug Development, Daiichi Sankyo (China) Holding Co. Ltd., China
roUnd-TabLe diScUSSion
Throughout the whole clinical trial critical path, from protocol development, IEC/IRB review, site contract, patient/subject recruitment, to safety monitoring and site closeout, smooth coordination and effective communication among stakeholders such as sponsor, PI/study site, IEC/IRB and CRO, are essential to ensuring high efficiency and quality of clinical trials.
In this session, speakers from clinical trial site, IEC/IRB, sponsor and CRO will share experiences on clinical trial preparation and management from each of their perspectives. All speakers/panelists will engage the audience in discussing how to build up smooth communication and coordination among all stakeholders to yield desired outcomes to all parties. The harmonization will lead to high efficiency in the clinical trial conduct with patient safety and rights in mind.
tuesDay, may 14, 2013 | conference Day 2WeDnesDay, may 15, 2013 | conference Day 3
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Regulators are enhancing their oversight of pharmacovigilance with the ultimate aim to achieve patient safety. What are some of the lessons we have learned and experience gained from pharmacovigilance inspections and sponsor internal audits? Can we plan for the future and build quality and compliance into our quality management system and pharmacovigilance processes?
In this section, discussion will focus on recent developments in EU Pharmacovigilance Legislation and common findings from PV inspections, and share one sponsor’s experience regarding how to build quality and compliance into the quality system and pharmacovigilance activities.
Recent Development in EU Pharmacovigilance Legislation and Common Findings from Pharmacovigilance Inspections
carrie ScoTTGPvP Operation Manager, Senior Pharmacovigilance Inspector, Medicines and Healthcare Products Regulatory Agency (MHRA), UK
Sponsor Internal PV Audits: Build Compliance and Effectiveness into PV Process
deborah driScoLL, PhdVice President, Medical Quality Assurance, Pfizer, USA
Session T 1-5 | wednesday, May 15, 201313:30 - 15:00 1st Floor, 5 C+F
chaLLengeS and oPPorTUniTieS aT cLinicaL TriaL SiTeS/inSTiTUTionS
session Co-Chairs
haiyan Li, Professor, Md Director, Drug Clinical Trial Center, Peking University 3rd Hospital; Vice Director, Peking University Clinical Research Institute, China
Shuting Li, MdDirector, GCP Center, The Cancer Hospital of Chinese Academy of Medical Sciences, China
The amount of clinical trials have increased greatly in recent years, and CFDA has paid more attention to quality than before through inspecting both sites and registration trials. Investigators are facing great challenge to ensure high quality of study conduct while running too many trials. How to cope with the challenge will be discussed in this session.
The Guaranteed Role of Efficient Management Program for Subjects Involved Clinical Research
Maozhi Liang, ProfessorDirector, GCP Center, West China Hospital of Sichuan University, China
A Survey of Clinical Trial Sites and Analysis in 2012
Shuting Li, MdDirector, GCP Center, The Cancer Hospital of Chinese Academy of Medical Sciences, China
The Role of Clinical Trial Center in Drug Development in China
haiyan Li, Professor, MdDirector, Drug Clinical Trial Center, Peking University 3rd Hospital; Vice Director, Peking University Clinical Research Institute, China
Session T 1-6 | wednesday, May 15, 201315:30 - 17:30 1st Floor, 5 C+F
eThicS coMMiTTee roLeS and deveLoPMenT in china
session Chair:
haitao LiU, Md, MS of international Public healthSenior Advisor, Clinical Development Quality Assurance Asia Pacific, Global Quality and Compliance, GSK R&D, China
The session focuses on the current ethical review practice and IEC construction in China: the strengths and challenges. It not only highlights the key areas of IEC construction in terms of infrastructure and system but also examines the existing paradigm defining the roles of EC, in terms of ensuring the protection of patient safety. It aims to develop an efficient review system and promote review quality.
Ensuring Patient Safety through Ethics Committee Oversight
cristina e. TorreS, PhdAsian Regional Coordinator, Forum for Ethical Review Committees in Asia Pacific (FERCAP), Philippines
Challenge and Consideration in Ethical Review
Xiuqin wang, Professor, PhdDeputy Director, Scientific Research DepartmentVice Chair, IRB, Jiangsu Province Hospital, China
Strategic Planning of Ethics Committee Infrastructure in Taiwan – A Critical Proactive Support for Clinical Research
herng-der chern, Md, PhdChief Medical Director, Supra Integration and Incubation Center, Taiwan
PaneL diScUSSion
Theme 2 | regulatory Science
Session T 2-1 | Tuesday, May 14, 2013 08:30 - 10:00 1st Floor, 5 A+B+G+H
gLobaL TrendS and china deveLoPMenT STaTUS on FiXed-doSe coMbinaTionS (Fdcs)
session Chair
wendy Yan, MdGlobal Regulatory Strategist, Asia Global R&D Center, Bayer Healthcare Co. Ltd., China
The development of fixed-dose combinations (FDCs) is becoming increasingly important from a public health perspective. They are being used in the treatment of a wide range of conditions e.g. HIV, hypertension and oral contraception, etc. There can be real clinical benefits in the form of increased efficacy and/or a reduced incidence of adverse effects. In addition, the cost of an FDC finished pharmaceutical product may be less than that of separate products given concurrently. Improved medication compliance by reducing the pill burden of patients may be difficult to prove, but there could be additional benefit. In this session, speakers from industry and hospital will share the experience of FDC development globally and its benefit to patients, the CFDA/CDE speaker will discuss the general principles, regulatory requirements, and concerns on FDC development in China.
Significance of the Fixed dose Combination (FDC) in Patients with Hypertension
wen wang, ProfessorNational Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences, China
How MNCs Develop FDCs with Scientific Rationale daniel PaULSon, Phd Global Clinical Leader, Bayer, USA
The General Principles, Regulatory Requirements and Concerns on FDC Development in China
cailian kang Senior Reviewer, Office of Clinical Evaluation II, CDE, CFDA, China
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Session T 2-2 | Tuesday, May 14, 2013 10:30 - 12:00 1st Floor, 5 A+B+G+H
new bioSiMiLar regULaTion: chaLLengeS and oPPorTUniTieS
session Chair
ning Li, Md, PhdVice President, Regulatory and Medical Policy, Asia Region, Sanofi, China
Since US FDA released its biosimilar guidance in 2011, the issue surrounding how to conduct a regulatory acceptable study following the guidance becomes very critical. This session will focus on regulatory requirement and trial design of biosimilar development.
US FDA Biosimilar Guidance Considerations
John gong, Md, PhdCEO, BL Pharma, China
How to Design A Biosimilar Clinical Study
Jian Peng, PhdScientific Advisor, Asia-Pacific R&D, Sanofi, China
CMC Related Issues in Biosimilars
haiqing dUan, PhdVice President, Medical Health Investment, Legendstar, China
Session T 2-3 | wednesday, May 15, 2013 08:30 - 10:00 1st Floor, 5 A+B+G+H
baLancing riSk and beneFiT dUring ind Period (JoinT SeSSion)
sessions Chair
Florence hoUn, Md, MPh, FacPCo-Chair of FDA Alumni Association International NetworkFormer Director, Office of Drug Evaluation III, US FDA/CDERVice President, Celgene Regulatory Policy and Strategy, USA
Risk and benefit assessment is the foundation of any regulatory decision-making. Despite significant progress made in the past decade in risk/benefit framework development, the challenge remains, especially in IND period where the benefit of a potential drug has not been adequately demonstrated. This is the Part I of Risk/Benefit at the FDA and beyond, focusing on FDA’s and CFDA/CDE’s approach to manage benefits and risk during IND period.
Balancing the Benefits and Risks During IND Period at US FDA
Mark J. goldberger, Md, MPh, FidSaFormer Director, Office of Drug Evaluation IV, US FDA/CDER, Member of FDA Alumni Association, Vice President, AbbVie Regulatory Intelligence and Policy, USA
Clinical Hold – An Important Tool of Risk Management During IND at US FDA
robert J. MeYer, MdFormer Director, Office of Drug Evaluation II, UCFDA/CDERMember of FDA Alumni AssociationAssociate Professor, Public Health Sciences, Director, The Virginia Center for Translational and Regulatory Sciences, School of Medicine, University of Virginia, USA
Statistical Considerations for Balancing the Benefits and Risks at US FDA
ning Li, Md, PhdVice President, Regulatory and Medical Policy, Asia Region, Sanofi, China
Approving Clinical Trial Application - Benefits and Risks Considerations at CFDA/CDE
Zhimin YangDeputy Director, Office of Clinical Evaluation I, CDE, CFDA, China
Session T 2-4 | wednesday, May 15, 2013 10:30 - 12:00 1st Floor, 5 A+B+G+H
baLancing riSk and beneFiT dUring nda and PoST-MarkeTing PeriodS (JoinT SeSSion)
sessions Chair
Mark J. goLdberger, Md, MPh, FidSaFormer Director, Office of Drug Evaluation IV, US FDA/CDERMember of FDA Alumni Association International Network (FDAAA)Vice President, AbbVie Regulatory Intelligence and Policy, USA
Risk and benefit assessment is the foundation of any regulatory decision-making. Despite of the progress made in the past decade, the significant challenge remains as we often witness the different opinions and decisions from regulatory agencies on same applications. This is PART II of Risk/Benefit at the FDA and beyond, focusing on how benefits and risks are weighed during the application review and in the postmarketing period. FDA’s use of external experts through a public advisory committee will be highlighted.
Overview of Benefit-Risk Assessment During the NDA Review and Post-Marketing Reassessment at US FDA
robert J. MeYer, MdFormer Director, Office of Drug Evaluation II, UCFDA/CDER Member of FDA Alumni Association Associate Professor, Public Health Sciences, Director, The Virginia Center for Translational and Regulatory Sciences, School of Medicine, University of Virginia, USA
Use of Public Advisory Committee in Risk/Benefit Assessment During NDA Review at US FDA
Florence hoUn, Md, MPh, FacPCo-Chair of FDA Alumni Association International NetworkFormer Director, Office of Drug Evaluation III, US FDA/CDERVice President, Celgene Regulatory Policy and Strategy, USA
Approving Marketing Application - Benefits and Risks Considerations at TFDA/CDE
Lih-Jiuan hSU, MdSenior Executive Officer, Division of Clinical Science, CDE, TFDA, Taiwan
Post-Marketing Reassessment in China
Siyan Zhan, MdProfessor, Department of Epidemiology, Beijing University Medical School, China
Panel Discussion
Session T 2-5 | wednesday, May 15, 2013 13:30 - 15:00 1st Floor, 5 A+B+G+H
TheraPeUTic bioLogic deveLoPMenT in china FroM cMc PerSPecTive
session Chair
Janet LvHead of Regulatory, Roche Product Development in Asia Pacific, China
Therapeutic biologics play more and more important role to address unmet medical needs. To timely introduce new therapeutic biologics with great
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efficacy and safety profile to China is also a shared goal of domestic industry, MNCs as well as Health Authorities. The session will focus on the best practice sharing in expediting CTA from CMC perspective, including dossier preparation, testing as well as challenge and recommended solution.
Dossier Preparation and Specification Validation during CTA
huiyang cheng, PhdDirector, Preclinical, Clinical and Registration, Genor BioPharm Co. Ltd., China
Melly Lin Regulatory Manager, CMC Policy/CMC, Roche (China) Holding Ltd., China
chunming raoDirector, Division of Recombinant Biological Products, NIFDC, China
Panel Discussion
Panelists:Speakers and:
Lixin XU, Md, PhdProduct Quality Reviewer, Office of Biotechnology Products, Division of Monoclonal Antibody, CDER, FDA, USA
anthony ridgwaY, PhdSenior Regulatory Scientist, Biologics and Genetic Therapies Directorate, Health Products and Food Branch, Health Canada
Session T 2-6 | wednesday, May 15, 2013 15:30 - 17:30 1st Floor, 5 A+B+G+H
iMPLeMenTaTion oF an innovaTive LabeLing hUb in aSia and inTegraTion wiTh gLobaL ModeL
session Co-Chairs
rie MaTSUi, rPhDirector, Regional Labeling Head for Asia, Labeling Operations and Translations, WSR International & Global Product Information, Pfizer, Japan
Tatsuo kiShiRisk Management Director, Office of Safety II, Pharmaceuticals and Medical Devices Agency (PMDA) , Japan
Many global companies operate a centralized labeling model in which the Company Core Data Sheet (CCDS) is handled by the Headquarters organization while local product documents and patient leaflets are handled by affiliates based in local offices. This session will provide an overview of the Global Labeling System covering the CCDS, USPI and EU-SPC, as well as a case study discussion on the implementation of an Asian regional hub model. Consideration of differences in practice across countries and companies, as well as the prospects for future initiatives around labeling will be discussed.
The session will also offer a perspective on how the industry is managing the integration and alignment of global safety and labeling systems and governance to ensure end to end oversight and implementation of patient safety information.
Global Safety Labeling in a Multinational Corporation
Matthias boedding, Professor, Md, PhdGlobal Safety Leader, Global Pharmacovigilance – Risk Management, Global R&D Center Beijing, Bayer Healthcare Co. Ltd., China
An Innovative Model for Handling Labeling in the Asian Region
rie MaTSUi, rPhDirector, Regional Labeling Head for Asia, Labeling Operations and Translations, WSR International & Global Product Information, Pfizer, Japan
Japanese Labeling Regulations
Tatsuo kiShiRisk Management Director, Office of Safety II, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Global Safety Labeling Process and Organization in US and EU Countries
Jeffrey hoPrincipal Officer, WCI Consulting Ltd. UK
Theme 3 | Drug Safety and Pharmacovigilance
Session T 3-1 | Tuesday, May 14, 2013 08:30 - 10:00 1st Floor, 5 D+E
PharMacovigiLance dUring Pre-aPProvaL – an eXciTing JoUrneY oF inveSTigaTion
session Chair
Feng (richard) Xia, Md, MS Medical Director, Former Global Pharmacovigilance Lead, Safety Evaluation and Reporting, Worldwide Safety and Regulatory, Pfizer Worldwide R&D, USA
Pharmacovigilance has shifted toward earlier, proactive consideration of risks and potential benefits of drugs and has become an important aspect in the development of novel medicinal products, all the way to their market introductions. Further advances in biology, pharmacology and improvements in computational applications to medicine have led to the development of more complex medicines previously unobtainable and have also allowed a more thorough assessment of risks and potential benefits even earlier in the development process. Elevated public concern with the safety of more sophisticated medicines, combined with new science, have led pharmaceutical innovators, regulators and healthcare professionals to collaborate to develop guidelines, which drive enhanced pharmacovigilance and safety risk management earlier in drug development. On the other hand, the pharmaceutical industry is evolving to actively respond to these new requirements and to ensure the upmost patient safety.
This session aims to provide a holistic view of safety in pre-approval stage, introducing the current thinking around pre-approval safety risk assessment, decision making, communication, and planning. The session will also bring practical examples from oncology clinical trials where special considerations about patient safety need to be taken.
From First-in-Human (FIH) to Market Authorization: Critical Aspects of Safety in Developing Innovative New Medicinal Products (Assessment, Decision Making, and Communication)
dan Zhang, Md, MPhChairman and CEO, Fountain Medical Development Ltd., China
Pre-approval Safety Review for New Drug Application -Key Considerations and Case Review
george chen, Md, MbaVice President and Head of Global Medicine Development in China, AstraZeneca Global Medicine Development, China
Panel Discussion ToPics
• Clinical Safety Review for Marketing Applications • Practical Aspects of Pre-Approval Risk Assessment• Individual and Aggregate Safety Reports• Safety Communication During Pre-Approval
Panelists:Speakers and:
Steven r. baiLeY, Md, MPh, MbaVice President, Worldwide Safety Strategy, Business Unit Lead forEmerging Markets and Established Products, Pfizer, USA
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Session T 3-2 | Tuesday, May 14, 2013 10:30 - 12:00 1st Floor, 5 D+E
PharMacovigiLance dUring PoST-aPProvaL - PaTh To SUcceSS
session Co-Chairs
Xingmin qiU, Md Director, World Safety and Regulatory, Pfizer China R&D Center, China
gang chengAssistant Director, National Center for ADR Monitor, Center for Drug Reevaluation, CFDA, China
The decision to approve a drug is based on the information available at the time of approval. The knowledge related to the safety profile of the product can change over time through expanded use in terms of patient characteristics and the number of patients exposed. In addition to routine post-approval safety monitoring activities, the appropriate pharmacovigilance methods employed for products with special safety concerns need to be applied. The best method chosen can vary with the product, the population, and the safety signal. Rigorously designed and conducted observational studies are recognized as important tools while active surveillance evolves in pharmacovigilance. In this session, the overview, initiatives and practices of these methods for post-approval products will be deeply discussed.
Is Grandfather Product Necessarily Safe? – The Experience of Phenylpropanolamine (PPA)
Yi TSong, PhdDeputy Director, Division of Biometrics VI, Office of Biostatistics, CDER, FDA, USA
Active Surveillance of Drug Safety – Concept, Methodology, and Development
Xiaofeng ZhoU, Phd, MPhDirector, Worldwide Safety & Regulatory, Pfizer Inc., USA
Application of Active Surveillance – Practical Examples
andy STergachiS, Phd, rPhProfessor, Epidemiology & Global HealthDirector, Global Medicines Program, School of Public Health, University of Washington, USA
Panel Discussion ToPics
• Post-Approval Safety Study – Which Way to Go• “Real World” Study• Challenge of Collecting Adverse Event Information in Post-Marketing
Setting - What Is the lesson learn from the Critics on Under Reporting of 80,000 Adverse Event Reports
Panelists:Speakers and:
catherine Xie, MdDirector, Safety Evaluation & Reporting, Worldwide Safety and Regulatory, Pfizer, China
Session T 3-3 | wednesday, May 15, 2013 08:30 - 10:00 1st Floor, 5 A+B+G+H
baLancing riSk and beneFiT dUring ind Period (JoinT SeSSion wiTh T2-3)
Session T 3-4 | wednesday, May 15, 2013 10:30 - 12:00 1st Floor, 5 A+B+G+H
baLancing riSk and beneFiT dUring nda and PoST-MarkeTing PeriodS (JoinT SeSSion wiTh T2-4)
Session T 3-5 | wednesday, May 15, 2013 13:30 - 15:00 1st Floor, 5 D+E
beneFiT-riSk: geTTing iT righT For PaTienTS
Session Co-Chairs
hugues berard, Md, MbaVice President, Deputy Chief Medical Officer, IPSEN R&D, France
gao gao, MdAssociate Director, Worldwide Safety & Regulatory, Pfizer China R&D Center, China
Monitoring benefit-risk balance is critical at each stage across the life cycle of drug development, review and post-approval activities. A Benefit-Risk assessment framework is recognized as important from both an agency and a company perspective. It is a rapidly moving field involving a number of ongoing initiatives across regulatory agencies and companies. The session aims to:
• Present the progress made on defining and implementing a benefit-risk methodology framework
• Provide industry perspectives and address the issues within the benefit risk-framework adopted by industry and regulatory authorities
• Share real-life examples on how companies implement different methodologies and their learnings
• Discuss how to achieve a consensus on a scientifically accepted approach for making benefit risk decision and the role of benefit-risk framework in drug innovation
Global Initiatives on Benefit-Risk Framework and Implementation: European PROTECT Project
Juhaeri JUhaeri, PhdAssociate Vice President, Head of Pharmacoepidemiology, Global Pharmacoviglance & Epidemiology, Sanofi, USA
Practical Considerations When Approaching Benefit-Risk: A Case Study Showing The Benefit of A MAHs Collaborative Approach
hugues berard, Md, MbaVice President, Deputy Chief Medical Officer, ISPEN R&D, France
Benefit-Risk Assessment and Risk Management in Drug Development Initiated from China
hua MU, Md, PhdExecutive Vice President & Chief Medical Officer, Hutchison Medi Pharma, China
Panel Discussion ToPics
• How to achieve a consensus on a scientifically accepted approach for making benefit risk decisions
• The role of benefit-risk framework in drug innovation
Session T 3-6 | wednesday, May 15, 2013 15:30 - 17:30 1st Floor, 5 D+E
doeS riSk ManageMenT PLanning beneFiT PaTienTS?
session Co-Chairs
Lynn ZhoU, Md, MPhInternational Pharmacovigilance Coordinator, PV Affiliate Relations, Global Pharmacovigilance & Epidemiology, Sanofi, China
Yun(Jackie) Mao, Md, MbaDirector, Worldwide Safety & Regulatory, Pfizer China R&D Center, China
Effective risk management planning (RMP) has been playing a critical role in drug development and commercialization, while debates remain that RMP could be burdensome to the healthcare system and potentially limit the access of patients to medicines. On the other hand, global harmonization of RMP is underway but the value of adopting local perspectives is intensively discussed because risk identification/categorization and selection of tools to minimize
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or mitigate the risk can be largely affected by local patient population and the delivery of the healthcare. The success of a risk management plan should be measured with consideration of value to the patients.
This session aims to:
• Provide overview of RMP regulation worldwide with focus on Asia regulation
• Introduce CIOMS working group IX (effectiveness of risk minimization)• Share real-life examples on how to use epidemiology study to evaluate
effectiveness of risk minimization • Discuss how to harmonize risk management & toolkit and maintenance as
the science of risk management evolves
The Global Risk Management Planning Landscape and a Few Asian Perspectives
william gregorYSenior Director, Safety Strategy, Policy and Standards, Pfizer, USA
Risk Management in Asia: Experience in Japan
Stewart gearY, MdChief Medical Officer, Vice President, Corporate Medical Affairs Headquarters, Eisai Co. Ltd., Japan
Observational Study for Risk Characterization and Assessment of Risk Minimization Tools
Juhaeri JUhaeri, PhdAssociate Vice President, Head of Pharmacoepidemiology, Global Pharmacoviglance & Epidemiology, Sanofi, USA
Theme 4 | Statistics
Sessions T 4-1 & T 4-2 | Tuesday, May 14, 2013 08:30 - 12:00 2nd Floor, 201 A
SaFeTY SignaL deTecTion and qUanTiTaTive aSSeSSMenT oF beneFiT/riSk raTio
sessions Co-Chairs
weiying YUan, Phd Site Head of Biostatistics and Programming, China Pharmaceutical Research and Development, Johnson and Johnson, China
roger qU, PhdHead of Clinical Statistics, Pfizer R&D Center, China
Protection of patient safety is paramount in the drug development and medical treatment. Statistics plays an essential role in the identification of potential safety signals and quantification of benefit/risk ratio which is integral part of safety assessment. This session will focus on statistical application in both areas, from both regulatory and sponsor perspective.
Statistical Considerations in Thorough QTc Clinical Trials
Yi TSong, PhdDeputy Director, Division of Biometrics VI, Office of Biostatistics, Center for Drug Evaluation and Research (CDER), FDA, USA
Sequential GLR Tests for Signal Detection
Jie chen, PhdDirector, Global Biostatistics, Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd., China
Statistical Considerations for Risk/Benefit Assessment
Marcia LevenSTein, ScdVice President and Head of Global Statistics of Specialty Care Business Unit, Pfizer, China
Bayesian Shrinkage Estimator for Safety Signal Detection
Luyan dai, PhdAssociate Director, Biostatistics, Boehringer Ingelheim Shanghai Pharmaceuticals Co. Ltd., China
Safety in Pharmacogenomics
Sue-Jane wang, PhdAssociate Director, Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research (CDER), FDA, USA
Panel Discussion
Session T 4-3 | wednesday, May 15, 2013 08:30 - 10:00 1st Floor, 5 D+E
overview oF MeTa-anaLYSiS and iTS aPPLicaTion in drUg deveLoPMenT
session Chair
wei Zhang, PhdRegional Head of Biometrics and Data Management, Asia/MENA, Boehringer Ingelheim Shanghai Pharmaceuticals Co. Ltd., China
One of the most commonly used statistical methodologies in medical research and drug development is Meta-analysis, such as hypothesis generating, determination of effect margin for non-inferiority clinical trials, integrated analysis treatment effect based on large number of clinical trials. If conducted inappropriately, its value would be diminished by various sources of biases. This session will promote the good practice of meta-analysis and introduce its recent development.
Meta-analysis in Drug Safety Evaluation: Statistical Challenges and Best Practices
george qUarTeY, PhdPrincipal Statistical Scientist, Biostatistics, Genentech, USA
Meta-analysis and Mixed Treatment Comparisons - Measuring and Reporting Direct and Indirect Evidence of Treatment Networks: Methodology, Software and Examples
hendrik SchMidT, PhdAssociate Director, Biostatistics, Boehringer Ingelheim, Germany
Meta-regression and Its Application in Clinical Trials
Feng chen, Professor, PhdDean, School of Public Health, Nanjing Medical University, China
Session T 4-4 | wednesday, May 15, 2013 10:30 - 12:00 1st Floor, 5 D+E
qUanTiTaTive ScienceS in PharMaceUTicaL deveLoPMenT (qSPd)
session Co-Chairs
william wang, PhdSite Head and Executive Director, Biostatistics and Research Decision Sciences - Asia Pacific (BARDS-AP), Merck Research Laboratories / MSD R&D (China) Co. Ltd., China
Yang Song, PhdSenior Principal Scientist, Biostatistics, Late Development Statistics, Biostatistics and Research Decision Sciences - Asia Pacific, MSD R&D (China) Co. Ltd., China
Quantitative Sciences in the pharmaceutical development encapsulate many disciplines such as biostatistics, epidemiology, health economics statistics, scientific programming, and data management. Collectively these scientific
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disciplines are playing increasingly important roles in pharmaceutical development. These important roles are reflected not only in strategic design, execution, but also in regulatory submission and regulatory decision making; not only for pharmaceutical development in the developed regions but also in the emerging market regions. This session will examine the top challenges and opportunities facing the quantitative science professionals.
Emerging Issues with Quantitative Sciences in Drug Development
hsien-Ming James hUng, PhdDirector, Division of Biometrics I, Office of Biostatistics, Center for Drug Evaluation and Research (CDER), FDA, USA
Panel Discussion ToPics• Roles of Modeling and Simulation• Quantitative Benefit-Risk Assessment• Complex Clinical Trial Designs• Predictive or Prognostic Characteristics of Biomarkers• Utilities and Pitfalls of Integrated or Meta Analyses• Globalization
Panelists:
hsien-Ming James hUng, PhdDirector, Division of Biometrics I, Office of Biostatistics, Center for Drug Evaluation and Research (CDER), FDA, USA
Sue-Jane wang, PhdAssociate Director, Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research (CDER), FDA, USA
Yuki andoSenior Scientist, Biostatistics Group, Center for Product Evaluation,
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Joan Shen, Md, PhdSenior Director, Clinical Development, Pfizer, China
Theme 5 | vaccines and biologics
Session T 5-1 | Tuesday, May 14, 2013 08:30 - 10:00 2nd Floor, 201 B+C
enSUring innovaTion and SaFeTY For ceLL/gene TheraPY and bLood ProdUcTS
session Chair
Florence hoUn, Md, MPh, FacPCo-Chair of FDA Alumni Association International Network (FDAAA)Former Director, Office of Drug Evaluation III, US FDA/CDERVice President, Celgene Regulatory Policy and Strategy, USA
A comprehensive presentation of the approaches to quality, efficacy and patient safety for the blood supply, cell, tissue, and gene therapies at the US FDA’s Center for Biologics Evaluation and Research (CBER) and in CFDA/Center for Drug Evaluation (CDE).
FDA’s Requirements for Safety and Efficacy for Cell/Gene Therapies
Jinjie hU, Phd Member of FDA Alumni Association International Network (FDAAA)Former Senior Reviewer, Office of Blood Research and Review, US FDA/CBERSenior Consultant, Biologics Consulting Group, INC., USA
China Update: Safety and Efficacy Requirements for Cellular/Gene Therapiesqi ShenDirector, Institute for Biological Product Control, NIFDC, China
FDA's Role in Blood Product Safety
Jinjie hU, Phd Member of FDA Alumni Association International Network (FDAAA)Former Senior Reviewer, Office of Blood Research and Review, US FDA/CBERSenior Consultant, Biologics Consulting Group, INC., USA
Ensuring the Safety and Efficacy of Blood Products in China
cFda Speaker invited
Session T 5-2 | Tuesday, May 14, 2013 10:30 - 12:00 2nd Floor, 201 B+C
PrinciPLeS For PandeMic inFLUenZa PreParedneSS and PoST-MarkeTing vaccine ManUFacTUring changeS
session Chair
Florence hoUn, Md, MPh, FacPCo-Chair of FDA Alumni Association International Network (FDAAA)Former Director, Office of Drug Evaluation III, US FDA/CDERVice President, Celgene Regulatory Policy and Strategy, USA
Ensuring safety for vaccines is a difficult but necessary duty of all regulatory agencies to promote public health and responsibilities of the biologics industry. US FDA and China FDA have had many years of experiences to share. Ensuring vaccine safety and effectiveness by balancing the need to encourage the adoption of new technologies to advance quality and efficient manufacturing of vaccines with the need to demonstrate, through appropriate validation and/or clinical or non-clinical laboratory studies, the lack of adverse effect of the change on the safety and effectiveness of the product remains a challenge. An update on recent US and Chinese activities regarding influenza vaccine production and preparedness and safety will be presented.
FDA and WHO Pandemic Influenza Vaccine Preparedness Activities
Sara e. gagneTen, PhdAssociate Director, Regulatory Policy, Office of Vaccines Research and Review, Division of Viral Products (DVP), CBER, FDA, USA
Advancing Vaccine Safety and Innovation in China
Jianhui LUoDeputy Office Director, Office of Biological Products, CDE, CFDA, China
Vaccine Applications at FDA: Regulations for Safety and Post-Marketing Changes
Sara e. gagneTen, PhdAssociate Director, Regulatory Policy, Office of Vaccines Research and Review, Division of Viral Products (DVP), CBER, FDA, USA
Session T 5-3 | Tuesday, May 14, 2013 13:30 - 15:00 2nd Floor, 201 B+C
ceLL TheraPY and bioSiMiLar deveLoPMenT, oPPorTUniTieS, and regULaTorY conSideraTionS
session Chair
Li Shi, PhdCEO, Shanghai Zerun Biotechnology Co. Ltd., China
The new stage of biological product development and usage in treating diseases has been on biosimilars and cell therapeutics. These two areas are playing increasingly important rules in the current and future growth of biological-based pharmacuticals. Cell therapy are facing not only technical but also regulatory challenges. For biosimilars, getting into regulated markets still
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needs great effort in meeting regulatory requirement. This session will review current status of cell therapy and biosimilar development, quality, safety and regulatory considerations.
Cell Therapy Development and Current Status in Its Application for Cosmetic Treatment
ningwen ZhU, Md, PhdCEO, Cell & Tissue Eng, China
Safety Evaluation and Research in China for New Biologics by Following the International GLP Standard
gene c. hSU, Phd, dabTVice President and CSO, Innostar and National Shanghai Center for New Drug Safety Evaluation and Research, China
Expectation and Opportunities of Bringing Biosimilars from China to EU, from Regulatory Point of View
hoss dowLaT, PhdVice President, Regulatory Affairs EU-USA, PharmaBio Consulting (Life Sciences), Germany
Session T 5-4 | Tuesday, May 14, 2013 15:30 - 17:30 2nd Floor, 201 B+C
vaccine ProdUcT qUaLiFicaTion and noveL hePaTiTiS vaccine deveLoPMenT For The worLd and china
session Chair
Li Shi, PhdCEO, Shanghai Zerun Biotechnology Co. Ltd., China
Vaccine product qualification and novel vaccine development have both been under much more serious consideration in China. Supplying vaccine made in China to the world has been getting on the agenda of China vaccine industry. WHO PQ activities and new GMP implementation have been a practical task already in China. Hepatitis diseases are among the most awared diseases in Asia countries including China. This session will review WHO PQ practice and hepatitis vaccines from effectiveness and new development point of view. This session will also review opportunities for international collaborations in developing new products for infectious diseases.
WHO Prequalification for Vaccines and Biologicals
nora deLLePiane, PhdGroup Leader of Essential Medicines and Health Products, WHO, Switzerland
Accurary of Titration Method for Detecting Live Attenuated Hepatitis A Vaccine
Xuanyi wang, Phd Professor, Shanghai Medical College, Fudan University, China
New Generation of Hepatitis Vaccine Development with Novel Adjuvant for Improving Vaccine
Tyler J. MarTin, MdPresident and Chief Medical Officer, Dynavax, USA
Cell Therapy and Biosimilar Development, Opportunities, and Regulatory Considerations
hoss dowLaT, PhdVice President, Regulatory Affairs EU-USA, PharmaBio Consulting (Life Sciences), Germany
Theme 6 | CMC
Sessions T 6-1 & T 6-2 | Tuesday, May 14, 2013 08:30 - 12:00 2nd Floor, 201 D
evaLUaTion oF generic ProdUcTS vS. reFerence ProdUcTS - The 2007 conUndrUM
session Co-Chairs
Min gUi, PhdDirector, CMC Asia Pacific, China CMC & Operation of the Global Regulatory Science, Bristol-Myers Squibb, China
chi-wan chen, Phd Member of FDA Alumni Association International Network (FDAAA)Former Deputy Director, Office of New Drug Quality Assessment, US FDA/CDERExecutive Director, Global CMC, Pfizer, USA
CFDA kicked off an initiative in 2012 for the reevaluation of generic products approved before 2007. This initiative aims to ensure safety, efficacy and quality of drug products for patients. How to make ensure a scientifically sound process is in place to achieve the goal? What are the practical challenges faced by the regulatory authority and industry?How to address the identified issues? This session is designed to discuss the generic products reevaluation, experiences in bioequivalence evaluation and in-vitro dissolution tests.
CFDA Working Procedures for the Generic Product Reevaluation Initiative
cFda Speaker invited
Rule for Reference Product Selection and Guidance on Comparative Dissolutionqiming ZhangResearcher, NIFDC, China
Bioequivalence and In Vitro Dissolution Studies – A US Industry Perspective Xiaoxiong (Jim) wei, Md, PhdMember of FDA Alumni Association International Network (FDAAA)Director, Clinical Pharmacology, Medpace, USA
IVIVC-Challenges and Considerationsdeepak hegde, PhdVice President, Formulation Development Services, WuXi AppTec Co. Ltd., China
Panel Discussion
Session T 6-3 | wednesday, May 15, 2013 08:30 - 10:00 2nd Floor, 201 D
regULaTorY PerSPecTiveS on boTanicaL drUg ProdUcTS in china and The UniTed STaTeS
session Chair
chi-wan chen, Phd Member of FDA Alumni Association International Network (FDAAA)Former Deputy Director, Office of New Drug Quality Assessment, US FDA/CDERExecutive Director, Global CMC, Pfizer, USA
A botanical product is regulated as a dietary supplement or drug, depending on its intended use, in the US FDA issued a guidance on Botanical Drug Products in 2004 to outline its recommendations on CMC information for different phases of clinical studies and for pre-NDA consideration. The guidance has enabled the industry and academia to begin studying botanical products for drug use, leading to the approval of the first botanical drug product in the US in 2006. This session will introduce the brief regulatory history of botanical drug
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products and discuss the challenges in developing such products in the US China’s long history and experience in regulating Traditional Chinese Medicines (TCM) will be presented as a comparison.
CFDA Requirements for Traditional Chinese Medicines (TCM)
Yuehua ZhoUDeputy Office Director, Office of Traditional Chinese Medicines, CDE, CFDA, China
Botanical Drug Products in the United States – Regulatory Background
duu-gong wU, PhdMember of FDA Alumni Association International Network (FDAAA)Director, Global Regulatory Affairs, Pharmaceutical Product Development, USA
Regulatory Challenges in Developing Botanical Drug Products in the United States
david Lin, PhdMember of FDA Alumni Association International Network (FDAAA) Senior Consultant, Biologics Consulting Group, USA
Panel Discussion
Session T 6-4 | wednesday, May 15, 2013 10:30 - 12:00 2nd Floor, 201 D
evoLUTion oF gLobaL bioTheraPeUTic regULaTionS – a cMc PerSPecTive
session Co-Chairs
Melly LinRegulatory Manager, CMC Policy, Roche (China) Holding Ltd., China
Min gUi, PhdDirector, CMC Asia Pacific, China CMC & Operation of the Global Regulatory Science, Bristol-Myers Squibb, China
Over the past decades, the development and application of new technologies have transformed the biotherapeutic product development, and drive the evolution of biotherapeutic regulatory framework. This session will introduce the evolution of global biotherapeutic regulations and the emerging regulatory concepts that will change the regulatory framework in the US & EU, such as life-cycle management approach for process validation, CMC change management protocol, etc. Application of the new ICH Q11 principles in biotherapeutic drug substance development will also be discussed. In addition, this session will cover the platform manufacturing for biotherapeutic development and use cases to demonstrate its application.
Evolution of the Biotherapeutic Regulations in USA and Driving Force Behind
Lixin XU, Md, PhdProduct Quality Reviewer, Office of Biotechnology Products, Division of Monoclonal Antibody, Center for Drug Evaluation and Research (CDER), FDA, USA
Application of ICHQ11 Principles in Biotherapeutic Drug Substance Development
anthony ridgwaY, PhdSenior Regulatory Scientist, Biologics and Genetic Therapies Directorate, Health Products and Food Branch, Health Canada
Modular Viral Validation for Platform mAb Purification Process
qi chen, PhdAssociate Director and Senior Scientist, Process Virology, Purification Development, Genentech Inc. USA
Theme 7 | Traditional Chinese Medicines (TCM)
Session T 7-1 | Tuesday, May 14, 2013 08:30 - 10:00 2nd Floor, 203 C
deveLoPMenT oF noveL TcM ProdUcTS For china and gLobaL MarkeT
session Chair
Xun Zhang, PhdVice President, Head of Global Natural Product Business Unit, GSK R&D, China
This session is to provide an overview of the R&D strategies and activities on the development of novel TCM products, as well as a forum for open discussion of the opportunities and challenges faced by the drug industry in its efforts to convert traditional herbal medicines into high quality, patent-protected, and clinically-proven products using global drug discovery and development technologies and standards.
TCM Industry Landscape
Junjie ZhoU, PhdGeneral Manager, Shanghai Hutchison Pharmaceuticals, China
R&D Strategy and Activity for New TCMs
Zuguang Ye, ProfessorDirector, TCM Platforms, China National Academy of Sciences, China
TCM Globalization Opportunity and Challenge
Xun Zhang, PhdVice President, Head of Global Natural Product Business Unit, GSK R&D, China
Session T 7-2 | Tuesday, May 14, 2013 10:30 - 12:00 2nd Floor, 203 C
caSe STUdieS and good PracTiceS in TcM deveLoPMenT
session Chair
Jack XU, MdSenior Vice President, Shanghai Clinical Research Center, China
The regulatory requirements, experience, and practices for TCM development will be discussed with case studies at this session. The session will also discuss what criteria should be used for TCM clinical evaluations.
China Regulatory Guidelines and Updates about TCM cFda Speaker invited
Clinical Research Update about TCMs in China
Jack XU, MdSenior Vice President, Shanghai Clinical Research Center, China
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Theme 8 | Target-based Oncology Drug Development co-organized by: us chinese anti-cancer association (uscaca)
Session T 8-1 | Tuesday, May 14, 2013 13:30 - 15:00 2nd Floor, 201 D
changing ParadigM in cancer diagnoSiS and TreaTMenT - iMPacT on drUg deveLoPMenT
session Co-Chairs
george chen, Md, MbaVice President and Head of Global Medicine Development of China, AstraZeneca Global Medicine Development, China
Li XU, Md, MSd, MbaVice President, Oncology China Strategy, Implementation, and Oncology Operations, Oncology Business Unit, Pfizer Inc., USA
This session will overview the current target-based novel cancer drug development and review two successful cases of target-based cancer drug development.
Overview and Introduction
Jorge PUenTe, MdPresident, Asia Pacific and Canada, Oncology Business Unit, Pfizer, USA
Case Study: Integrating Biomarkers into Clinical Trials of New Therapies in Cancer, Right Drug for the Right Patients at the Right Time
• Case 1 - Xalkori for ALK+ NSCLC
Maria koehLer, Md, PhdVice President, Integrated Development Leader and Strategic and Scientific Assessments, Clinical Development and Medical Affairs, Oncology Business Unit, Pfizer Inc., USA
• Case 2 - BRAF Inhibitor for BRAF V600e/k Mut Melanoma
Jun gUo, Professor, Md, PhdDirector, Department of Kidney & Melanoma Vice President, Peking University Cancer Hospital & Institute, China
Session T 8-2 | Tuesday, May 14, 2013 15:30 - 17:30 2nd Floor, 201 D
STraTegieS For diScoverY and deveLoPMenT oF TargeT-baSed noveL cancer MedicineS
session Co-Chairs
george chen, Md, MbaVice President and Head of Global Medicine Development of China, AstraZeneca Global Medicine Development, China
Li XU, Md, MSd, MbaVice President, Oncology China Strategy, Implementation, and Oncology Operations, Oncology Business Unit, Pfizer Inc., USA
This session will discuss the strategies for discovering, developing and registering novel target-based cancer drugs with quality, speed and value. In addition, this session will also discuss what China needs to do to transit from participating to leading target-based cancer drug development.
Novel Cancer Target Identification and Validation
Jennifer Yang, PhdDirector, Science Affairs, Johnson & Johnson Asia R&D Center, China
Clinical Development Strategy: Identify Right Target Population, Utilize Optimal Endpoints and Study Designs, and Leverage China Opportunities
hua MU, Md, PhdExecutive Vice President and Chief Medical Officer, Hutchison Medi Pharma, China
China’s Role in Participating and Leading Discovery and Development of Novel Oncology Medicine
caicun ZhoU, Professor, PhdDirector, Medical Oncology, Shanghai Pulmonary Hospital, Tongji University, China
Theme 9 | Pharm/Tox
Session T 9-1 | wednesday, May 15, 2013 08:30 - 10:00 2nd Floor, 201 B+C
PharM/ToX: FroM aniMaL To hUMan
session Chair
John gong, Md, PhdMember of FDA Alumni Association International Network (FDAAA)CEO, BL Pharma, China
A comprehensive presentation of requirements for preclinical safety evaluations in the US FDA and China CFDA. Discussions will be focused on the following: preclinical safety data analysis and interpretation; extrapolation of animal toxicity findings to humans; and methods on how to use animal data to predict potential human risk and support regulatory decisions.
FDA Requirements for Preclinical Safety Evaluations
Paul a. andrewS, PhdExecutive Director, Global Regulatory Affairs, Eisai Inc. USA
CFDA Requirements for Preclinical Safety Evaluations
Jian Peng, PhdScientific Advisor, Asia Pacific R&D, Sanofi, China
Panel Discussion
Session T 9-2 | wednesday, May 15, 2013 10:30 - 12:00 2nd Floor, 201 B+C
gLP regULaTorY coMPLiance For daTa qUaLiTY and inTegriTY
session Chair
dylan d. Yao, Md, PhdMember of FDA Alumni Association International Network (FDAAA)Senior Vice President and CSO, Joinn Laboratories, Inc., China
Comprehensive presentations regarding GLP compliance issues associated with preclinical data quality and integrity from the view point of both CRO and government regulatory agency to ensure subjects safety.
GLP Compliance Issues ImpActing Data Quality and Integrity in Preclinical Studies - A CRO’S Point of View
Jane PearSe, PhdDirector, Special Projects, Huntingdon Life Sciences, UK
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Importance of GLP & Safety Testing to Public Health Mission - A Perspective of FDAdylan Yao, Md, PhdMember of FDA Alumni Association International Network (FDAAA) Senior Vice President and CSO, Joinn Laboratories, Inc. China
PanelisTs
Speakers and
Lijie FU, Phd, FeLLow aTSGeneral Manager, China Business, Senior Advisor of Regulatory, SNBL Vice President, Chinese Society of Toxicology, China
conglin ZUo, MdPresident and CEO, Joinn Laboratories, Inc., China
Session T 9-3 | wednesday, May 15, 2013 13:30 - 15:00 2nd Floor, 201 B+C
PaTienT SaFeTY : ToXicoLogicaL evaLUaTion and riSk aSSeSSMenT in PharMaceUTicaL r&d
session Co-Chairs
Lijie FU, Phd, FeLLow aTSGeneral Manager, China Business/Senior Advisor of Regulatory, SNBLVice-President of Chinese Society of Toxicology
charles Y. wang, Phd, dabTDirector, Safety Assessment, GSK R&D, China
This session focuses on toxicology in pharmaceutical safety evaluation and risk assessment, specifically the importance of pharmaceutical products and safety evaluation in China, as well as non-clinical risk assessment in compound license-in, which is a primary strategy for Chinese pharmaceutical industry.
Hazard vs. Risk - Toxicology Consideration
Lijie FU, Phd, FeLLow aTSGeneral Manager, China Business/Senior Advisor of Regulatory, SNBLVice-President of Chinese Society of Toxicology
Drug Safety Assessment for Stem Cell-based Medicinal Products
Jing Ma, Md, Phd Director, National New Drug Safety Evaluation and Research Shanghai Center, China
Safety Evaluation of Chinese Traditional Medicines: Rhubarb and Its Major Constituents
quanjun wang, Md, Phd Assistant Director, National Beijing Center for Drug Safety Evaluation and Research, China
Non-Clinical Safety Assessment during Compound License-In
charles Y wang, Phd, dabTDirector, Safety Assessment, GSK R&D, China
Theme 10 | Clinical Data Management/eClinical
Session T 10-1 | wednesday, May 15, 2013 08:30 - 10:00 2nd Floor, 201 A
TechnoLogY advanceMenT in The LandScaPe oF cLinicaL daTa ManageMenT
session Chair
daniel LiU, PhdDirector, China Development, Medidata Solutions Worldwide, China
Technology is changing the clinical research landscape from protocol development, data acquisition and data exchange. Clinical Research is behind other industries in taking advantage of the uses of technology and information so it is important to know the trend such as cloud technology and tools to move the industry forward. This session will discuss the benefit of technologies to data managers and will provide a picture into the future of how it may impact our field.
Big Data Computing – Current Concept and Practice
glen de vrieSPresident, Medidata Solutions, USA
Suitable Cloud Implementation for Life Sciences Research
abhishek baggaManager, Clinical Systems Center of Excellence, Life Sciences R&D Practice, Cognizant Technology Solutions, India
Bioinformatic Tools in Data Analysis and Management
eric S. herbeLPresident, Integrated Clinical Systems, USA
Panel Discussion
Session T 10-2 | wednesday, May 15, 2013 10:30 - 12:00 2nd Floor, 201 A
daTa ManagerS' roLeS in drUg SaFeTY
session Chair
Joanne LiU, MdDirector, Global Clinical Data Management & Standard, MSD R&D (China) Center, China
This session will provide practical ideas on how to ensure the safety data quality through data validation plan, data review process and medical coding process. Hear from experienced speakers who have been successful in managing safety data and learn more about how you might address key challenges when managing safety data.
Considerations in Safety Data Validation and SAE Reconciliation
Jessie chen, MdHead of Clinical Data Services, Pfizer China R&D Center, China
Safety Data Management in Phase I Study
gang XU, MdDirector, Data Management, GSK R&D, China
Coding in Safety Data Management
Lobo LooAssociate Director, China Data Management Center, MSD R&D, China
Panel Discussion
67
Session T 10-3 & T 10-4 | wednesday, May 15, 2013 13:30 - 17:30 2nd Floor, 201 A
daTa STandardS in reaL worLd cLinicaL reSearch
session Co-Chairs
Zibao Zhang, PhdAssociate Director, Biostatistics and Programming, PPD, China
Yazhong deng, MbaHead of Clinical Data Analysis and Reporting Organization (CDARO), Covance, China
Data Standard is a continued hot topic to streamline clinical research and modernize data and information flow in drug development. This session will focus on the added values of standardization and implementation approaches around the globe.
The audience will hear from experts who have been successful in their endeavors and learn how one could address the key challenges of integrating standard into clinical trials. Updates of the CDISC standards implementation and regulatory considerations in China will be shared.
From Electronic Health Record to Clinical Database
demetris ZaMbaSExecutive Director, Global Data Management & Standards, MSD, USA
CDISC Standards Implementation Experiences from a Global CRO
niklas MorTonVice President, Biostatistics and Programming, PPD, USA
Case Studies with CDISC Standards: from CDASH to SDTM and AdaM
victor wU, PhdSenior Manager, Biostatistics, Covance, China
CDISC Standards to Enhance Clinical Trial Efficiency
ivan Tjong-a-hUng, Md, MbaGeneral Manager, Athena Healthcare Consultancy, China
Updates of CDISC Standards in China
Linda wang, Master in health StatisticsPrinciple Biometrician, Integrated Information Sciences Department, Novartis, ChinaChina CDISC Coordinating Committee (C3C)
Panel Discussionqin hUang, PhdDeputy Office Director, Office of Biostatistics, CDE, CFDA, China
Theme 11 | Innovation on Medical Devices and Combinational Products
Sessions T 11-1 & T 11-2 | wednesday, May 15, 2013 08:30 - 12:00 2nd Floor, 203 C
MedicaL deviceS: innovaTion, regULaTion and inveSTMenT
session Co-Chairs
katherine wang, LLMChief China Life Sciences Advisor, Ropes & Gray, China
Spring wang, MdRegional Clinical Director, St. Jude Medical, Asia Pacific, Hong Kong, China
The session will cover topics of medical device innovation, registration and financing. With participations of senior and experienced experts, speakers will provide comprehensive review of the newly released medical devices GCP guideline by CFDA, innovations, roles of venture capital and cases studies on medical devices.
Innovation on Medical Devices
kok-hwee ng, PhdDirector, Instrumentation Development, Center for Innovation and Strategic Collaboration, St. Jude Medical, Inc. USA
The Draft GCP on Devices in China
cFda department of Medical device Supervison Speaker invited
Streamlining Medical Device Clinical Trial
Xianqiang Mi, Professor, Md, PhdShanghai Advanced Research Institute, Chinese Academy of Science, China
Medical Device Innovation: A Case Study
katherine wang, LLMChief China Life Sciences Advisor, Ropes & Gray, China
Role of Venture Capital in Medical Devices
Fay Xing, MdPricipal, Decheng Capital, China
Theme 12 | Contract Service Organization
Session T 12-1 | wednesday, May 15, 2013 13:30 - 15:00 2nd Floor, 201 D
how To bUiLd win-win reLaTionShiP
session Chair
helen Jiang, Md, PhdExecutive Medical Director, Jiangsu Hengrui Medicine Co. Ltd., China
In the journey of drug/device development, companies are not necessary to have all the scientific and operational capability and capacity to undertake all tasks, especially when it is related to patient safety or to the resolution to help patient out of disease suffering. The session will be emphasizing that the outsourcing decision is based on multiple factors besides money, with the aim to outline the various business need for CRO companies, including contribution to science/medicine, special area of service, delegated function services partner, in-sourcing people, and full service outsourced project.
How to Leverage Safety Data from Chinese Population to File IND in US Successfully?
Simon Li, Md, PhdVice President, Global Clinic Trials and Regulatory Affair, Luye Pharma, China
Early Development: CRO Selection and Partnership
anfan wU, PhdHead of Early Development, Roche R&D Center (China) Ltd., China
Case Study: A Chinese Company Successfully Filed IND in US with CRO Support
Zaiqi wang, Md, PhdExecutive Director, Clinical Research, MSD, China
Collaboration to Win a Path to Success
helen Jiang, Md, PhdExecutive Medical Director, Jiangsu Hengrui Medicine Co. Ltd., China
68
Session T 12-2 | wednesday, May 15, 2013 15:30 - 17:30 2nd Floor, 201 D
conTracT Service organiZaTion – vaLUe-added TaSkForce To enSUre PaTienT SaFeTY
session Co-Chairs
Yanhua gong, MdVice President & Secretary General of CROU (CRO Union), China Association for Pharmaceutical and Medical Technology Exchange, China
Jessica LiU, MdGeneral Manager, China/North Asia, INC Research, China
The session will discuss how Contract Service Organizations (CSO) build infrastructure in China to develop high performance team.
Strategic Alliance on Pharmacovigilance to Support Patient Safety Management in Clinical Trial
Sheona STevenSon, PhdAssociate Director of PVG, Head of Asia-Pacific Region, INC Research, Singapore
Clinical Monitoring in China – Assuring Quality from the CRO Perspective
emily TanExecutive Director, Clinical Research Asia Pacific, InVentiv Health Clinical, Singapore
The Business Development of a Domestic CRO after IPO
Sally Sha, MdDirector, Business Development, Project Director, Hangzhou Tigermed Consulting Co. Ltd., China
Panel Discussion
Theme 13 | Post-approval and real World Studies
Session T 13-1 | wednesday, May 15, 2013 15:30 - 17:30 2nd Floor, 201 B+C
PoST-aPProvaL and reaL worLd STUdieS
session Chair
danyi Zhang, MdFounder and the Chief Medical Officer, VitalStrategic Research Institute (VSRI), China
After a drug is approved for marketing, scientific and medical research continues. Numerous study methodologies and mechanisms are available to further study and evaluate its efficacy and safety in the real word setting as well as to identify its potential new uses. The session will examine the trend, practicality, issues, and possible solutions surrounding the application of these methods in China.
Introduction and Overview
danyi Zhang, MdFounder and the Chief Medical Officer, VitalStrategic Research Institute (VSRI), China
Patient Registry
Yan Xiao, Md, PhdSenior Epidemiologist, Roche Pharma Development Center, Asia Pacific, China
Investigator-Initiated Studies:
1. case i :Frank Fan, PhdSenior Medical Director, Sanofi, China
2. case ii:Yilong wang, PhdVice Division Chief, Department of Internal Neurology, Beijing TianTan Hospital, China
Theme 14 | Pharmacoepidemiology - best Practices and Drug Safety
Session T 14-1 | wednesday, May 15, 2013 13:30 - 15:00 2nd Floor, 203 C
PharMacoePideMioLogY - drUg SaFeTY and beST PracTiceS
session Chair
wei ZhoU, Md, PhdDirector, Epidemiology Asia Pacific Unit, Merck Research Laboratories, China
This session is to share the status and progress of pharmacoepidemiology in drug safety and risk management, as well as comparative-effectiveness research.
Introduction of Basic Pharmacoepidemiology Principles and Methods in Drug Development and Risk Management
Siyan Zhan, Professor, Md, PhdDeputy Director, Department of Epidemiology and Bio-Statistics, Peking University Health Science Center, China
Regulatory Perspective and Progress of Pharmacoepidemiology and Drug Safety
cFda department of drug Safety & inspection Speaker invited
Recent Progress of Pharmacoepidemiology Research - Using Large Emr and Claim Databases, and Comparative-Effectiveness Research on Drug Safety and Efficacy of Different Treatments and Drugs.
arnold k. chan, Md, Scd, FiSPeChief Scientist, Medical Research Department, National Taiwan University Hospital, Taiwan
Theme 15 | Drug eLeCTrONIC ADMINISTrATION IN CHINA
Session T 15-1 | wednesday, May 15, 2013 15:30 - 16:15 2nd Floor, 203 C
inTrodUcTion oF drUg eLecTronic adMiniSTraTion
Yingli wangDeputy Director, Division of Information Research & Planning, Information Center, CFDA, China
69
壁报 PoSTer PrograMPOSTER TITLE
CATEGORY AUTHOR ORGANIZATION COUNTRY
estimation of combined Youden index and its application in Meta-analysis Professional Jiangmei LIU Southern Medical University China
comparison of goodness-of-fit and Time-dependent covariates approaches for Testing Proportional hazards assumption in cox regression ModelProfessional Yankui OU PPD China
clinical data Management – rapid, accelerate, Standard, and Localized Solutions Professional Ruiling PENG NNIT China
wuhan quality operations Processing center Student Kuan Long CHEONG University of Macau China
adaptive axis Scaling in SaS graph Process Professional Yanzhuo PAN Pfizer (Wuhan) Research and Development Co., Ltd China
神经心理测验和评定量表在阿尔茨海默病中的应用 Student Luwen ZHANG Fudan University China
Managing TMF quality Professional Zhouhang ZHANG (张宙航) Pfizer Wuhan Research and Development Center China
diversity of Pharmacovigilance Post-Marketing Practices in the asia-Pacific region Professional Lynn ZHOU Sanofi China
上市后药物新适应症临床试验中不良事件数据收集的优化
Student Han GAO(高菡) Fudan University China
由中成药市场现状引发的对于中成药临床试验的思考 Student Yunhui WANG(王云慧) Fudan University China
我国药物性肝损伤评价的现状与展望 Student Liuliu YUAN(袁柳柳) Fudan University China
The application and Prospects of cdiSc (cdiSc的应用与发展前景) Student Juan SUN(孙娟) Fudan University China
The importance of validated edc System to ensure quality of data Professional Carol HOU, MD Athena Healthcare Consultancy China
electronic data capture (edc): Providing a Significant cost-efficient Platform in current clinical research Management Professional Carol HOU, MD Athena Healthcare Consultancy China
The adoption of electronic data capture (edc) for clinical Trial data Management in china – The case of athena healthcare consultancy Professional Ivan Tjong-A-HUNG, MD MBA Athena Healthcare Consultancy China
crohn's disease activity index and related Statistic models in crohn's disease clinical Study Student Xingxing LIU(刘星星) Fudan University China
a reporting System for the defects of Medicinal Products in Taiwan Professional Hsien Yu HSIAO, Wen Wen CHEN, Angela ON Taiwan Drug Relief Foundation China
The evaluation of risk Factors for adverse events Using disproportionality Student Jun KE, Wenlu TANG, Ping YAN, Zhijuan YU Fudan University China
centrally Monitoring in-Study ratings for an alzheimer’s disease Trial conducted in asia Professional Joan (Huaqiong) SHEN, MD, PhD Pfizer Inc. China
Patient First - investigator initiated research advances Medical Scientific research as well as Patient Safety Protection
Professional Pei MAO, Fang WANG, Jing WAN, Alexander KOSTEK Pfizer Inc. China
Post-marketing Surveillance in Pharmacovigilance
Professional Zhang QING, Wang DAN, Yao LAN Pfizer (Wuhan) Research Development Co. Ltd China
70
lasT naMe FiRsT naMe session
ANDO Yuki WS-5 & T4-4
ANDREWS Paul A. T9-1
BAGGA Abhishek T10-1
BAILEY Steven R. T3-1
BERARD Hugues T3-5
BOEDDING Matthias T2-6
BRAJOVIC Sonja WS-4
BU Xin WS-2
CAVAZZONI Patrizia Plenary
CHAN Arnold K. T14
CHEN Jessie T10-2
CHEN Qi T6-4
CHEN Jie T4-1 & T4-2
CHEN Feng T4-3
CHEN George T3-1, T8-1 & T8-2
CHEN Li T1-2
CHEN Hannah T1-3
CHEN Chi-Wan T6-1, T6-2 & T6-3
CHEN Zhen CFDA Townhall
CHENG Huiyang T2-5
CHENG Gang T3-2
CHERN Herng-Der T1-6
DAI Luyan T4-1 & T4-2
DAI Xin T1-3
DELLEPIANE Nora T5-4
DENG Yazhong T10-3 & T10-4
DOWLAT Hoss T5-3 & T5-4
DRISCOLL Deborah T1-4
FAN Frank T13
FU Lijie T9-2 & T9-3
GAGNETEN Sara E. T5-2
GAO Gao T3-5
GEARY Stewart T3-6
GOLDBERGER Mark J. T2-3 & T3-3, T3-3 & T3-4
GONG John T2-2 & T9-1
GONG Yanhua T12-2
GREGORY William T3-6
GREN Jeffrey WS-6
GU Gary WS-6
GU Vivian T1-1 & T1-2
GUI Min T6-1, T6-2 & T6-4
GUO Jun T8-1
HAWKINGS Elaine T1-1
HEDGE Deepak T6-1 & T6-2
HERBEL Eric S. WS-1 & T10-1
HO Jeffery T2-6
HOUN Florence T2-3 & T3-3, T2-4 & T3-4, T5-1 & T5-2
lasT naMe FiRsT naMe session
HSU Gene C. T5-3
HSU Lih-Jiuan T2-4 & T3-4
HU Jinjie T5-1
HU John WS-6
HUANG Qin T4-4 & T10-4
HUNG Hsien-Ming James WS-5 & T4-4
JIANG Helen T12-1
JUHAERI Juhaeri T3-5 & T3-6
KANG Cailian T2-1
KEITEL Susanne WS-6
KIM Jongran T1-1
KISHI Tatsuo T2-6
KOEHLER Maria T8-1
KRAUZE PIOTR WS-6
KRIEG Madeleine WS-1
LEVENSTEIN Marcia T4-1 & T4-2
LI Simon T12-1
LI Shuting T1-2,T1-3 & T1-5
LI Helen T1-3 & T1-4
LI Jinju T1-3
LI Haiyan T1-5
LI Ning T2-2, T2-3 & T3-3
LIANG Maozhi T1-5
LIN David T6-3
LIN Melly T2-5 & T6-4
LINDQUIST Maria WS-1
LIU Daniel WS-1 & T10-1
LIU Zhiwei WS-6
LIU Haitao T1-6
LIU Joanne T10-2
LIU Jessica T12-2
LOO Lobo T10-2
LUO Jianhui T5-2
LV Janet T2-5
MA Jing T9-3
MAO Jackie T3-6
MARTIN Tyler J. T5-4
MATSUI Rie T2-6
MENG Lin Plenary
MEYER Robert J. T2-3 & T3-3; T2-4 & T3-4
MI Xiangqiang T11-1 & T11-2
MIYAZAKI Koichi T1-1
MORTON Niklas T10-3
MU Hua T3-5 & T8-2
NG Kok-Hwee T11-1 & T11-2
PAULSON Daniel T2-1
PEARSE Jane T9-2
讲者索引 speaker Index
71
lasT naMe FiRsT naMe session
PENG Jian T2-2 & T9-1
PUENTE Jorge T8-1
QIU Xingmin T3-2
QU Roger T4-1 & T4-2
QUARTEY George T4-3
RAO Chunming T2-5
RIDGWAY Anthony T2-5 & T6-4
RUAN Joan WS-2
SANG Guowei Plenary
SCHMIDT Hendrik T4-3
SCOTT Carrie T1-4
SHA Sally T12-2
SHEN Qi T5-1
SHEN Joan T4-4
SHI Li T5-3 & T5-4
SHOU Qiong WS-5
SMITH Nicole Taylor WS-6
SONG Yang T4-4
STERGACHIS Andy T3-2
STEVENSON Sheona T12-2
SU Ling WS-6 & Plenary
SATO Yutaka WS-1
TAN Lingshi Plenary
TAN Emily WS-3 & T12-2
TJONG-A-HUNG Ivan T10-3
TORRES Cristina E. T1-6
TOSETTI Patrizia WS-6
TSONG Yi T3-2, T4-1 & T4-2
VILLAX Guy WS-6
VRIES Glen De T10-1
WANG Yilong T13
WANG Zaiqi T12-1
WANG Katherine T11-1 & T11-2
WANG Linda T10-3
WANG Quanjun T9-3
WANG Charles Y. T9-3
WANG Hainan T7-2
WANG Xuanyi T5-4
WANG Sue-Jane WS-5, T4-1, T4-2 & T4-4
WANG Juan WS-3
WANG William WS-5 & T4-4
WANG Lifeng WS-6
WANG Gang WS-6
WANG Xiuqin T1-6
WANG Wen T2-1
WANG Yingli T15
WANG Spring T11-1 & T11-2
lasT naMe FiRsT naMe session
WEI Xiaoxiong T6-1 & T6-2
WU Anfan T12-1
WU Aijun T11-1 & T11-2
WU Victor T10-3
WU Duu-Gong T6-3
WU Shuling WS-3
WU Kiki WS-3
WU Yan T2-1
WU Xueying T1-3
XIA Richard T3-1
XIAO Yan T13
XIE Catherine T3-2
XING Fay T11-1 & T11-2
XU Gang T10-2
XU Juncai T7-2
XU Lixin T2-5 & T6-4
XU Li WS-3, T8-1 & T8-2
YAN Min T14
YAN Charles WS-3
YAN Wendy T2-1
YANG Jennifer T8-2
YANG Chen WS-6
YANG Zhimin T2-3 & T3-3
YAO Dylan D. T9-2
YE Zuguang T7-1
YUAN Weiying T4-1 & T4-2
ZAMBAS Demetris T10-3
ZEE Benny Chung-Ying T1-1
ZHAN Siyan T2-4, T3-4 & T14
ZHANG Danyi T13
ZHANG Xun T7-1
ZHANG Qiming T6-1 & T6-2
ZHANG Dan T3-1
ZHANG We WS-3
ZHANG Wei WS-6
ZHANG Zibao T10-3 & T10-4
ZHAO Yajun Plenary
ZHAO-WONG Anna WS-4
ZHOU Caicun T8-2
ZHOU Junjie T7-1
ZHOU Yuehua T6-3
ZHOU Xiaofeng T3-2
ZHOU Lynn T3-6
ZHOU Wei T14
ZHU Ningwen T5-3
ZUO Conglin T9-2
讲者索引 speaker Index
109
07:30 - 16:00
现场注册
13:30 - 17:30 开幕式
全体大会 二层， 一号厅
15:00 - 15:30 茶歇
15:30 - 17:30 主旨嘉宾演讲
促进药物创新，保障患者安全桑国卫 中国药学会理事长 中国工程院院士
风险管理计划：促进创新确保患者安全PaTriZia a. cavaZZoni 博士 辉瑞全球研发中心高级副总裁 全球安全和上市产品及仿制药物监管部负责人肿瘤靶向药物的研发
艾滋病病毒携带者治疗药物现状和期待 孟林 北京爱之方舟感染者信息支持组织负责人 中国艾滋病病毒携带者联盟秘书处协调员 中国全球基金项目国家协调委员会非工委代表
17:30 - 19:30 欢迎招待会 — 中国之夜
DIA中国五周年庆典
会前专题研讨 1二层, 201 B
运用数据分析技术监控和评价临床研究质量
和结果
会前专题研讨 2二层, 201 C
原料药和制剂的稳定性要求与实践
会前专题研讨 3二层, 201 D
肿瘤临床试验中的数据管理
会前专题研讨 4二层, 203 C
从药物监管角度看MedDRA (ICH国际医学用语词典) 在临床试验药物安全和药物警戒
方面的应用
会前专题研讨 5二层, 201 A
全球性药物临床试验的原则和案例研究
专题研讨 6三层, 307
药品安全和原料药: 全球对原料药的监管及法律的要求和实践
12:00 - 13:30 午餐
2013年5月12日 星期日 | 会前专题研讨
2013年5月13日 星期一 | 会议日程(第一天)
110
专题 1
临床研究与运作
专题 2
监管科学
专题 3
药物安全和药物警戒
专题 4
统计学
专题 5
疫苗和生物制品
专题 6
化学、生产和质控(cMc)
专题 7
传统中药创新
08:30 - 10:00 平行会议
分会场 T 1-1一层, 5 C+F
成功的全球临床试验-优化利益，降
低风险
分会场 T 2-1一层, 5 A+B+G+H
固定剂量复方制剂(FDCs)在中国及全
球的发展
分会场 T 3-1一层, 5 D+E
上市批准前的药物警戒 - 探索研究
分会场 T 4-1二层, 201 A
安全性信号检测和效益/风险定量评估
(一)
分会场 T 5-1二层, 201 B+C
确保细胞/基因疗法和血液制品的创新
和安全
分会场 T 6-1二层, 201 D
仿制药与参比制剂之比较与评价—仿制药质量一致性评
价 (一)
分会场 T 7-1二层, 203C
开发适用于中国及全球的创新性中药
10:00 - 10:30 茶歇
专题 1
临床研究与运作
专题 2
监管科学
专题 3
药物安全和药物警戒
专题 4
统计学
专题 5
疫苗和生物制品
专题 6
化学、生产和质控(cMc)
专题 7
传统中药创新
10:30 - 12:00 平行会议
分会场 T 1-2一层, 5 C+F
临床试验中各方的协调与沟通
分会场 T 2-2一层, 5 A+B+G+H
生物类似药新的监管： 挑战与机遇
分会场 T 3-2一层, 5 D+E
产品批准上市后的药物警戒 – 长期的
任务
分会场 T 4-2二层, 201 A
安全性信号检测和效益/风险定量评估
(二)
分会场 T 5-2二层, 201 B+C
流感大流行应急准备原则以及批准上市后疫苗生产的变更
分会场 T 6-2二层, 201 D
仿制药与参比制剂之比较与评价—仿制药质量一致性评
价 (二)
分会场 T 7-2二层, 203C
中药开发的案例分析与实践
12:00 - 13:30 午餐
国家食品药品监督管理总局专场会 专题 5
疫苗和生物制品
专题 8
肿瘤靶向药物的研发
13:30 - 15:00 平行会议
国家食品药品监督管理总局 (CFDA) 专场会：中国药品上市前和上市后的安全监管
一层, 3号会议厅
分会场 T 5-3二层, 201 B+C
细胞药物和生物类似药的研发 - 机遇及
监管要求
分会场 T 8-1二层, 201 D
肿瘤诊断和治疗模式的改变对药物研
发的影响
15:00 - 15:30 茶歇
国家食品药品监督管理总局专场会 专题 5
疫苗和生物制品
专题 8
肿瘤靶向药物的研发
15:30 - 17:30 平行会议
国家食品药品监督管理总局 (CFDA) 专场会：中国药品上市前和上市后的安全监管
一层, 3号会议厅
分会场 T 5-4二层, 201 B+C
中国与全球的疫苗产品认证和肝炎新
疫苗研发
分会场 T 8-2二层, 201 D
肿瘤靶向创新药物研发策略
2013年5月14日 星期二 | 会议日程(第二天)
111
专题 1
临床研究与运作
专题 2 & 3
监管科学与药物安全专场
专题 4
统计学
专题 6
化学、生产和质控(cMc)
专题 9
药物毒理
专题 10
数据管理和电子临床
专题 11
医疗器械药械组合产品的创新
08:30 - 10:00 平行会议
分会场 T 1-3一层, 5 C+F
GCP临床研究机构
分会场 T2-3 & T3-3一层, 5 A+B+G+H
新药临床试验/IND阶段的风险与受益
权衡
分会场 T 4-3一层, 5 D+E
Meta分析及其在药品开发中的应用
分会场 T 6-3二层, 201 D
中美植物药监管展望
分会场 T 9-1二层, 201 B+C
药物毒理：从动物试验到人体试验
分会场 T 10-1二层, 201 A
科技进展对临床数据管理的影响
分会场 T 11-1二层, 203C
医疗器械的创新、监管及研发投资 (
一)
10:00 - 10:30 茶歇
专题 1
临床研究与运作
专题 2
监管科学与药物安全专场
专题 4
统计学
专题 6
化学、生产和质控(cMc)
专题 9
药物毒理
专题 10
数据管理和电子临床
专题 11
医疗器械药械组合产品的创新
10:30 - 12:00 平行会议
分会场 T 1-4一层, 5 C+F
从质量保证的角度谈药物警戒
分会场 T2-4 & T3-4一层, 5 A+B+G+H
美国FDA新药注册申请/NDA和上市后的风险与受益评估
及再评价
分会场 T 4-4一层, 5 D+E
药物研发中的定量科学
分会场 T 6-4二层, 201 D
全球生物制药法规的发展—CMC视角
分会场 T 9-2二层, 201 B+C
GLP法规；数据的质量和完整性
分会场 T 10-2二层, 201 A
安全数据管理 – 数据管理者的职责
分会场 T 11-2二层, 203C
医疗器械的创新、监管及研发投资 (
二)
12:00 - 13:30 午餐
专题 1
临床研究与运作
专题 2
监管科学
专题 3
药物安全和药物警戒
专题 12
合同研究机构
专题 9
药物毒理
专题 10
数据管理和电子临床
专题 14
药物流行病学的最佳实践和药物安全
13:30 - 15:00 平行会议
分会场 T 1-5一层, 5 C+F
临床研究机构面临的机遇与挑战
分会场 T 2-5一层, 5 A+B+G+H
在中国开发治疗用生物制品 – CMC
视角
分会场 T 3-5一层, 5 D+E
为患者的利益平衡效益和风险
分会场 T 12-1二层, 201 D
如何建立双赢关系
分会场 T 9-3二层, 201 B+C
药物研发的毒理评价和风险评估
分会场 T 10-3二层, 201 A
数据标准在临床研究中的应用和成功
案例 (一)
分会场 T 14二层, 203C
药物流行病学的最佳实践和药物安全
15:00 - 15:30 茶歇
专题 1
临床研究与运作
专题 2
监管科学
专题 3
药物安全和药物警戒
专题 12
合同研究机构
专题 13
上市后和实际环境中的药物研究
专题 10
数据管理和电子临床
专题 15
中国药品电子监管
15:30 - 17:30 平行会议
分会场 T 1-6一层, 5 C+F
中国伦理委员会的职责和发展
分会场 T 2-6一层, 5 A+B+G+H
创新的标签说明书中心体系在亚洲的应用及与国际体系
的整合
分会场 T 3-6一层, 5 D+E
制定风险管理计划有益于患者吗？
分会场 T 12-2二层, 201 D
合同研究机构对确保药品安全所起的
作用
分会场 T 13二层, 201 B+C
上市后和实际环境中的药物研究
分会场 T 10-4二层, 201 A
数据标准在临床研究中的应用和成功
案例 (二)
分会场 T 15二层, 203C
药品追溯体系建设 – 药品电子监管
(15:30 - 16:15)
2013年5月15日 星期三 | 会议日程(第三天)
112
07:30 - 16:00
ReGisTRaTion
13:30 - 17:30 oPeninG PlenaRY session
oPeninG PlenaRY session 2nd Floor, Conference Hall 1
15:00 - 15:30 Tea BReaK
15:30 - 17:30 KeYnoTe sPeecH
encouRaGe DRuG innovaTion anD ensuRe PaTienT saFeTYProfessor Guowei sanG, MD President, chinese Pharmaceutical association (cPa)academician, chinese academy of engineering
RisK ManaGeMenT PlanninG sPuRs innovaTion anD enaBles PaTienT saFeTYPatrizia a. cavaZZoni, Md senior vice President, Worldwide safety and established Products Regulatory, Pfizer inc. usa
sTaTus anD exPecTaTions aBouT aRv TReaTMenT FoR PeoPle livinG WiTH Hiv lin MenG Director, ark of love information center,General secretary of china alliance of People living with Hiv/aiD Representative of country coordinating Mechanism (ccM) of the Global Fund china Programs
17:30 - 19:30 WelcoMe RecePTion - cHina niGHT
Dia cHina 5TH anniveRsaRY celeBRaTion
08:30 - 17:30 PReconFeRence WoRKsHoPs
WoRKsHoP 12nd Floor, 201 B
Analysis of Data Patterns to Monitor and Assess Outcomes of Clinical
Studies
WoRKsHoP 22nd Floor, 201 C
Drug Substance and Drug Product Stability
Requirements and Practices
WoRKsHoP 32nd Floor, 201 D
Data Management for Oncology Trials
WoRKsHoP 42nd Floor, 203C
Applying MedDRA in Clinical Safety and Pharmacovigilance
Practices: Regulatory Perspective
WoRKsHoP 52nd Floor, 201 A
Global Clinical Trials in Drug Development - Principles and Case
Studies
WoRKsHoP 63rd, 307
National Drug Safety and Active Pharmaceutical
Ingredients (APIs) in China: Development of
Recommendations for the Regulation of APIs
12:00 - 13:00 lunch
MONDAY, MAY 13, 2013 | CONFERENCE DAY 1
SUNDAY, MAY 12, 2013 | PRECONFERENCE WORKSHOPS ONLY
113
THeMe 1
clinical ReseaRcH & oPeRaTions
THeMe 2
ReGulaToRY science
THeMe 3
DRuG saFeTY anD PHaRMacoviGilance
THeMe 4
sTaTisTics
THeMe 5
vaccines anD BioloGics
THeMe 6
cMc
THeMe 7
DeveloPMenT anD ReGulaTions FoR
TRaDiTional cHinese MeDicines (TcM)
08:30 - 10:00 PaRallel THeMes
session T 1-11st Floor, 5 C+F
Clinical Excellence When Involving China in Global
Clinical Development: Maximize Benefits and Minimize Risks
session T 2-11st Floor, 5 A+B+G+H
Global Trends and China Development
Status on Fixed-dose Combinations
(FDCs)
session T 3-11st Floor, 5 D+E
Pharmacovigilance during Pre-approval–An Exciting Journey
of Investigation
session T 4-12nd Floor, 201 A
Safety Signal Detection and Quantitative
Assessment of Benefit/Risk Ratio
- Part I
session T 5-12nd Floor, 201 B+C
Ensuring Innovation and Safety for Cell/Gene Therapy and
Blood Products
session T 6-12nd Floor, 201 D
Evaluation of Generic Products
vs. Reference Products - The 2007 Conundrum - Part I
session T 7-12nd Floor, 203C
Development of Novel TCM Products for China and Global
Market
10:00 - 10:30 Tea BReaK
THeMe 1
clinical ReseaRcH & oPeRaTions
THeMe 2
ReGulaToRY science
THeMe 3
DRuG saFeTY anD PHaRMacoviGilance
THeMe 4
sTaTisTics
THeMe 5
vaccines anD BioloGics
THeMe 6
cMc
THeMe 7
DeveloPMenT anD ReGulaTions FoR
TRaDiTional cHinese MeDicines (TcM)
10:30 - 12:00 PaRallel THeMes
session T 1-21st Floor, 5 C+F
Coordination and Communication
among Stakeholders of Clinical Trials
session T 2-21st Floor, 5 A+B+G+H
New Biosimilar Regulation:
Challenges and Opportunities
session T 3-21st Floor, 5 D+E
Pharmacovigilance during Post-approval
- Path to Success
session T 4-22nd Floor, 201 A
Safety Signal Detection and Quantitative
Assessment of Benefit/Risk Ratio
- Part II
session T 5-22nd Floor, 201 B+C
Principles for Pandemic Influenza Preparedness
and Post-marketing Vaccine Manufacturing
Changes
session T 6-22nd Floor, 201 D
Evaluation of Generic Products
vs. Reference Products - The 2007 Conundrum - Part II
session T 7-22nd Floor, 203C
Case Studies and Good Practices in TCM Development
12:00 - 13:30 luncH BReaK
cFDa ToWnHall MeeTinG THeMe 5
vaccines anD BioloGics
THeMe 8
TaRGeT-BaseD oncoloGY DRuG
DeveloPMenT
13:30 - 15:00 PaRallel THeMes
cFDa ToWn HallPre-marketing and Post-marketing Drug Safety Supervision in China
Organized by: China Food and Drug Administration (CFDA)1st Floor, Conference Hall 3
session T 5-32nd Floor, 201 B+C
Cell Therapy and Biosimilar Develop- ment, Opportunities,
and Regulatory Considerations
session T 8-12nd Floor, 201 D
Changing Paradigm in Cancer Diagnosis
and Treatment - Impact on Drug Development
15:00 - 15:30 Tea BReaK
cFDa ToWnHall MeeTinG THeMe 5
vaccines anD BioloGics
THeMe 8
TaRGeT-BaseD oncoloGY DRuG
DeveloPMenT
15:30 - 17:30 PaRallel THeMes
cFDa ToWn HallPre-marketing and Post-marketing Drug Safety Supervision in China
Organized by: China Food and Drug Administration (CFDA)1st Floor, Conference Hall 3
session T 5-42nd Floor, 201 B+C
Vaccine Product Qualification and Novel Hepatitis
Vaccine Development for China and the
World
session T 8-22nd Floor, 201 D
Strategies for Discovery and
Development of Target-based Novel Cancer Medicines
TUESDAY, MAY 14, 2013 | CONFERENCE DAY 2
114
THeMe 1
clinical ReseaRcH & oPeRaTions
THeMes 2 & 3
ReGulaToRY anD saFeTY
(JoinT session)
THeMe 4
sTaTisTics
THeMe 6
cMc
THeMe 9
PHaRM/Tox
THeMe 10
DaTa ManaGeMenT anD eclinical
THeMe 11
innovaTion FoR MeDical Devices
anD coMBinaTional PRoDucTs
08:30 - 10:00 PaRallel THeMes
session T 1-31st Floor, 5 C+F
GCP Clinics
sessions T2-3 & T3-31st Floor, 5 A+B+G+H
Balancing Risk and Benefit during IND
Period
session T 4-31st Floor, 5 D+E
Overview of Meta-Analysis and Its
Application in Drug Development
session T 6-32nd Floor, 201 D
Regulatory Perspectives on Botanical Drug
Products in China and the United States
session T 9-12nd Floor, 201 B+C
Pharm/Tox: From Animal to Human
session T 10-12nd Floor, 201 A
Technology Advancement in the Landscape of Clinical Data Management
session T 11-12nd Floor, 203C
Medical Devices: Innovation,
Regulation and Investment
- Part I
10:00 - 10:30 Tea BReaK
THeMe 1
clinical ReseaRcH & oPeRaTions
THeMe 2
ReGulaToRY anD
saFeTY(JoinT session)
THeMe 4
sTaTisTics
THeMe 6
cMc
THeMe 9
PHaRM/Tox
THeMe 10
DaTa ManaGeMenT anD eclinical
THeMe 11
innovaTion FoR MeDical Devices
anD coMBinaTional PRoDucTs
10:30 - 12:00 PaRallel THeMes
session T 1-41st Floor, 5 C+F
Pharmacovigilance - QA Perspective
sessions T2-4 & T3-41st Floor, 5 A+B+G+H
Balancing Risk and Benefit during NDA and Post-marketing
Periods
session T 4-41st Floor, 5 D+E
Quantitative Sciences in Pharmaceutical
Development (QSPD)
session T 6-42nd Floor, 201 D
Evolution of Global Biotherapeutic
Regulations – A CMC Perspective
session T 9-22nd Floor, 201 B+C
GLP Regulatory Compliance for Data Quality and Integrity
session T 10-22nd Floor, 201 A
Data Managers' Roles in Drug Safety
session T 11-22nd Floor, 203C
Medical Devices: Innovation,
Regulation and Investment
- Part II
12:00 - 13:30 luncH BReaK
THeMe 1
clinical ReseaRcH & oPeRaTions
THeMe 2
ReGulaToRY science
THeMe 3
DRuG saFeTY anD PHaRMacoviGilance
THeMe 12
conTRacT seRvice oRGanizaTion
THeMe 9
PHaRM/Tox
THeMe 10
DaTa ManaGeMenT anD eclinical
THeMe 14
PHaRMaco-ePiDeMioloGY-
DRuG saFeTY anD BesT PRacTices
13:30 - 15:00 PaRallel THeMes
session T 1-51st Floor, 5 C+F
Challenges and Opportunities at
Clinical Trial Sites/Institutions
session T 2-51st Floor, 5 A+B+G+H
Therapeutic Biologic Development in China from CMC
Perspective
session T 3-51st Floor, 5 D+E
Benefit-Risk: Getting It Right for Patients
session T 12-12nd Floor, 201 D
How to Build Win-Win Relationship
session T 9-32nd Floor, 201 B+C
Patient Safety: Toxicological
Evaluation and Risk Assessment in
Pharmaceutical R&D
session T 10-32nd Floor, 201 A
Data Standards in Real World Clinical Research - Part I
session T 142nd Floor, 203C
Pharmacoepidemiology - Drug Safety and Best
Practices
15:00 - 15:30 Tea BReaK
THeMe 1
clinical ReseaRcH & oPeRaTions
THeMe 2
ReGulaToRY science
THeMe 3
DRuG saFeTY anD PHaRMacoviGilance
THeMe 12
conTRacT seRvice oRGanizaTion
THeMe 13
PosT-aPPRoval anD Real WoRlD
sTuDies
THeMe 10
DaTa ManaGeMenT anD eclinical
THeMe 15
DRuG elecTRonic aDMinisTRaTion in
cHina
15:30 - 17:30 PaRallel THeMes
session T 1-61st Floor, 5 C+F
Ethics Committee Roles and
Development in China
session T 2-61st Floor, 5 A+B+G+H
Implementation of an Innovative
Labeling Hub in Asia and Integration with
Global Model
session T 3-61st Floor, 5 D+E
Does Risk Management
Planning Benefit Patients?
session T 12-22nd Floor, 201 D
CRO : Value-added Taskforce to Ensure
Patient Safety
session T 132nd Floor, 201 B+C
Post-approval and Real World Studies
session T 10-42nd Floor, 201A
Data Standards in Real World Clinical Research - Part II
session T 152nd Floor, 203C
Introduction of Drug Electronic Administration
(15:30 - 16:15)
WEDNESDAY, MAY 15, 2013 | CONFERENCE DAY 3
May 11-14, 2014Shanghai, China
6th
ANNUAL MEETING
dia china
7/F, Room 766, Metropolis Tower
No.2 Haidian East Third Street, Zhongguancun Xi Zone
Haidian District, Beijing, 100080, China
Tel: +86.10.6260.2240
dia worLdwide headqUarTerS
800 Enterprise Road, Suite 200, Horsham, PA 19044
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