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Final Programme

7 t h A n n u A l

CliniCAl ForumD u b l i n 2013

8-9 October 2013 The Convention Centre Dublin, Ireland

Rebooting Clinical Development

Including European Medical Information & Communication Conference

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TABLE OF CONTENTS

Welcome from the Clinical Forum 2013 Chair .................................................................3

Programme Committee .........................................................................................................4

Clinical Forum at a Glance ....................................................................................................5

General Information ............................................................................................................6-7

Fellowship Programme ..........................................................................................................8

Student & Young Professionals Programme ....................................................................9

Workshop ................................................................................................................................. 10

Plenary Session ....................................................................................................................... 11

Cross-Functional Session ..................................................................................................... 11

Theme 1: Clinical Operations ......................................................................................... 12-13

Theme 2: Technical Operations .................................................................................... 13-14

Theme 3: Medical Affairs ................................................................................................ 14-15

Theme 4: Medical Information ...................................................................................... 16-17

Theme 5: Medical Writing .............................................................................................. 18-19

DIA Membership ................................................................................................................... 20

Networking Opportunities ...................................................................................................21

Exhibition Guide .............................................................................................................. 22-23

Exhibitor Services ...........................................................................................................25-26

Glossary ....................................................................................................................................27

Continuing EducationDIA meetings and training courses are generally approved by the Commission for Professional Development (CPD) of the Swiss Association of Pharmaceutical Professionals (SwAPP) and the Swiss Society of Pharmaceutical Medicine (SGPM) and will be honoured with credits for pharmaceutical medicine. All participants are eligible for these credits and certificates are available on request from the DIA registration desk.

The Clinical Forum has been awarded with 12 CPD credits for the conference and 3 CPD credits for the workshops from the Faculty of Pharmaceutical Medicine (FPM) of the Royal College of Physicians (RCP) of the UK. Medical practitioners who are eligible for credits can click on http://www.fpm.org.uk/cpd/registration for more information. If you are already a CPD member, please go directly to http://cpd.fpm.org.uk to claim your credits.

CLINICAL FORUM SCHEDULE

Monday, 7 October 2013

PRE-CONFERENCE WORKSHOPS | CLARION HOTEL IFSC

14:00 – 17:30 Workshop 1: The Clinical Trials Transformation Initiative

14:00 – 17:30 Workshop 2: Electronic Archives Are Not Your System Backup

Media

14:00 – 15:30 Student & Young Professionals Pre-Conference

15:30 – 16:00 Coffee Break

17:00 – 18:00 Student & Young Professionals Networking Reception

18:30 Kick-off Gathering at the Doheny and Nesbitt public house

Tuesday, 8 October 2013

CONFERENCE | The CCD

08:00 – 09:00 Registration and Welcome Coffee

09:00 – 10:30 Session 1 – See Programme Overview to make your choice

from the five parallel sessions

10:30 – 11:00 Coffee Break in the Exhibition Hall

11:00 – 12:30 Session 2 – Choose from parallel sessions

12:30 – 14:00 Lunch in the Exhibition Hall

14:00 – 15:30 Session 3 – Medical Information

14:00 – 15:30 Plenary Debate:

This House Believes That in Ten Years There Will Be no Clinical

Trial Operations Staff in Europe



17:30 – 19:30 Tuesday Networking Reception in the Exhibition Hall

Wednesday, 9 October 2013

CONFERENCE | The CCD

08:00 – 09:00 Registration and Welcome Coffee

09:00 – 10:30 Session 5 – Risk Based Monitoring Part I and parallel sessions


11:00 – 12:30 Session 6 – Risk Based Monitoring Part II and parallel sessions

12:30 – 14:00 Lunch in the Exhibition Hall




17:30 End of Conference

Unless otherwise disclosed, DIA Europe acknowledges that the statements made by speakers are their own opinion and not necessarily that of the organisation they represent, or that of DIA Europe. Speakers and agenda are subject to change without notice.

Recording of any DIA Europe tutorial/workshop/session information in any type of media is prohibited without prior written consent from DIA Europe.

MEDIA PARTNERS We would like to thank our Media Partners!

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INCLUDED IN YOUR CONFERENCE REGISTRATION FEE:

Two full days of scientific sessions on Tuesday and WednesdayChoose from parallel sessions covering five themes and hot topics

Student and young professional pre-conferenceMonday, 7 October 2013 | 14:00 – 18:00 | Clarion Hotel IFSC

Plenary session with Oxford-style debate Tuesday, 8 October 2013 | 14:00 – 15:30

THIS HOUSE BELIEVES THAT IN TEN YEARS THERE WILL BE NO CLINICAL TRIAL OPERATIONS STAFF IN EUROPE

All refreshment breaks and lunches during conference

Networking reception | Tuesday, 8 October 2013 | 17:30 – 19:30

High-key cross-functional double session on Risk-Based Monitoring Wednesday, 9 October 2013 | 09:00 – 12:30

PROGRAMME CHAIR

Detlef Nehrdich Senior Associate

Waife & Associates Inc.Germany

Dear Friends and Colleagues,

It is my pleasure to welcome you to the 7th Annual DIA Clinical Forum in Dublin, Ireland.

The DIA Clinical Forum is a conference bringing together experts from different fields, including data management, clinical operations, drug safety, medical affairs, medical information and medical writing. Experts share their expertise and experience with people from other companies and disciplines. Making the presentations and workshops relevant to the day to day work of participants has always been the focus of previous programme committees – and I am glad to confirm that this has been a priority for our work also this year.

Dublin, the European Capital of Science in 2012, has a long tradition as a respected seat of education and sciences. With innovative biotechnology companies and third party providers, together with its world renowned universities and colleges, Dublin is an ideal venue for the exchange of ideas.

“Rebooting Clinical Development” is our overall programme theme. For many reasons clinical development has experienced substantial challenges over the last couple of years. Looking at the changing and even more demanding regulatory landscape, the trend of shifting major operational pieces of clinical development to China and India and innovative concepts such as “virtual” trials, it becomes evident that many more changes are expected. It may require a “reboot”, and a deep breath of fresh Irish air to see where we are and in which direction we may need to go.

I want to thank the outstanding Programme Committee who have been the driving force behind the conference. I also thank the session chairs, speakers and instructors for their invaluable contributions. None of this could be achieved without the excellent support of the team at DIA.

I wish you a productive and enjoyable conference and hope that you will make the most of the opportunity to expand your personal and professional network over the two days.

Detlef Nehrdich, Programme Chair

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CliniCAl ForumD u b l i n 2 0 1 3

ADDITIONAL EVENTS:Unofficial kick-off gathering at the Doheny & Nesbitt public house

Monday, 7 October 2013 from 18:30Everyone welcome. Self-pay. No advance registration.

Half-day Workshops EUR 250.00 | Monday, 7 October 2013 | 14:00 – 17:30 | Clarion Hotel IFSCFor further details see page 10 of this programme.

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Rolf Banholzer Development QA Systems and Standards, Global Head GxP IT Systems & Processes, Novartis Pharma AG Switzerland

Graham Bunn VP Partnerships, Perceptive InformaticsUK

Aaron Cockell Medical Information Regional Director, EMEA, Pfizer Inc.UK

Janet Davies Director, Medical Information & Medical Affairs Project Management, EAME, Gilead SciencesUK

Estrella GarciaHead of Global Clinical Operations, Almirall S.A.Spain

Jan Geissler Director, The European Patients’ Academy on Therapeutic Innovation (EUPATI)Belgium

Julianne HullCEO, WenStar EnterprisesUK

Pierre-Yves Lastic Associate Vice-President, Chief Privacy Officer, SanofiFrance

Breffni MartinLegal Representative, Optuminsight Strategic Regulatory ServicesIreland

Jens ReinholdMedical Director ZAO Bayer, Bayer Healthcare Pharmaceuticals RussiaRussian Federation

Holger Maria Rohde Medical Operations Officer, TEVA Pharma GmbHGermany

Heike SchönManaging Director, LUMIS InternationalGermany

Mary Gardner StewartDivisional Director, Medical Documentation, H. Lundbeck A/SDenmark

Peter StokmanHead Global Data Management & Standards Oss, Merck Sharp and DohmeThe Netherlands

Fergus SweeneyHead of Sector, Compliance and Inspection, European Medicines AgencyEuropean Union

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Sandra HeckerUS Agent, Regulatory Consultant, Hecker & Associates, LLCUSA

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CliniCal Forum 2013 Programme Committee

StaY ConneCteDStay Connected at DIA EuropeCommunity on Linkedin

Stay Connected at #DIA_CF

Stay Connected at https://www.facebook.com/DIA.Europe

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Monday, 7 October 2013 Pre-Conference | Hotel Clarion

Session 114:00 – 15:30 Workshop 1

The Clinical Trials Transformation Initiative(See page 10)

Workshop 2 Electronic Archives are not your System Backup Media

(See page 10)

Student and Young Professional

Pre-Conference Session(See page 9)Session 2

16:00 – 17:30

Theme 1Clinical Operations

(See page 12-13)

Theme 2Technical Operations

(See page 13-14)

Theme 3Medical Affairs

(See page 14-15)

Theme 4Medical Information

(See page 16-17)

Theme 5Medical Writing(See page 18-19)

Tuesday, 8 October 2013 | The CCD

Session 109:00 – 10:30

Transparency from Clinical TrialsLiffey Hall 1

New Technologies to Reboot Clinical Trials - Part I

Wicklow Hall 2A

Post-Approval Studies and Virtual Studies

Liffey Meeting Room 5

Translating Data into Insights

Liffey Hall 2

Implications of the New Pharmacovigilance

LegislationWicklow Hall 2B

10:30 – 11:00 Coffee Break in the Exhibition Hall LIFFEY

Session 211:00 – 12:30

Patient Recruitment and Retention in Clinical Trials

Liffey Hall 1

New Technologies to Reboot Clinical Trials -

Part IIWicklow Hall 2A

Maximising the Value of Post-Approval Studies through

Publication ExcellenceLiffey Meeting Room 5

Prove your Value! Marketing Medical Information

Liffey Hall 2

Risk Management PlansWicklow Hall 2B

12:30 – 14:00 Lunch in the Exhibition Hall LIFFEY

Session 314:00 – 15:30

Plenary Debate: “This House Believes That in Ten Years there will be no Clinical Trial Operations Staff in Europe”

Wicklow Hall 2A+2B

New EU Pharmacovigilance Legislation and the Impact on

Medical InformationLiffey Hall 2

Plenary DebateWicklow Hall 2A+2B


Session 416:00 – 17:30

Improving Clinical Development Performance

Liffey Hall 1

Clinical Data Standards: Your quality enabler!

Wicklow Hall 2A

Pharmacovigilance – Innovation and interfaces

Liffey Meeting Room 5

MI QualityLiffey Hall 2

Clinical Trial RegistriesWicklow Hall 2B

17:30 – 19:30 Networking Reception in the Exhibition Hall LIFFEY

Wednesday, 9 October 2013 | The CCD

Session 509:00 – 10:30

Risk Based Monitoring - Part IWicklow Hall 2A

Emerging MarketsLiffey Hall 2

Regional ConsiderationsWicklow Hall 2B


Session 611:00 – 12:30

Risk Based Monitoring - Part IIWicklow Hall 2A

Regional and Global Management Aspects

Liffey Hall 2

Storyline DocumentsWicklow Hall 2B

12:30-14:00 Lunch in the Exhibition Hall LIFFEY

Session 714:00 – 15:30

Choose from Parallel Sessions

The Smart Approach to ePRO

Wicklow Hall 2A

Patient Centred Studies - Innovative approaches to

include patientsLiffey Hall 1

Technology and Social Media

Liffey Hall 2

Submission ChallengesWicklow Hall 2B


Session 816:00 – 17:30

Health Economics Outcome Research (HEOR)

Liffey Hall 1

Benefits of the CloudWicklow Hall 2A

Choose from Parallel Sessions

Theory into PracticeLiffey Hall 2

Successful ReviewsWicklow Hall 2B

CliniCal Forum 2013 aT a GlanCE

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General Information A-Z

BADGESPlease wear your conference badge at all times. Only participants with a valid conference badge will be allowed into the CCD first and second floor areas and to attend sessions.

CONVENTION CENTRE DUBLIN, The (The CCD)Spencer DockNorth Wall QuayDublin 1IrelandTelephone: + 353 1 856 00 00http://www.theccd.ie

CERTIFICATE OF ATTENDANCEPick up your certificate of attendance! The DIA Customer Services Team will print your certificate on request onsite at the Registration Desk on Wednesday, 9 October 2013. If you prefer to receive your certificate electronically after the conference, please email us on [email protected] or call +41 61 225 51 51.

CHECK IN FOR YOUR FLIGHT ONLINESave time by checking in online and printing your boarding card at the Online Check-In Terminal in the main entrance hall on the ground floor of the CCD.

CLOAKROOM / BAGGAGEThe cloakroom is located on the ground floor, in the main entrance hall, to your left. On the day of your departure you can also store your luggage there.Cloakroom opening hours:Tuesday 08:00 – 20:00Wednesday 08:00 – 18:00

DIA BOOTHFind out more about all DIA can offer you, about DIA membership benefits and how to get involved. Visit the DIA booth in the Liffey Exhibition Hall on the first floor.DIA booth opening hours:Tuesday 10:30 – 19:30Wednesday 10:00 – 16:00

DIA FELLOWSHIPSDIA actively promotes the involvement of students and young professionals in the Clinical Forum. The Networking Area in the Liffey Exhibition Hall on the first floor acts as a focal point for fellows and other stakeholders to meet and network. Find out more about future opportunities at the DIA booth.

EXHIBITIONThe exhibition offers opportunities to connect with attendees from a variety of pharmaceutical industry job functions and disciplines, while exploring new technologies. A full list of exhibitors and a floor plan can be found on page 23. All refreshment breaks will be served in the Liffey Exhibition Hall on the first floor.Exhibition opening hours:Tuesday 10:00 – 19:30Wednesday 10:00 – 16:00

FIRST AIDWe hope that you enjoy a healthy and safe conference. Medical advice and help will be available if needed. For further information, please contact the DIA Registration Desk in the first floor foyer.

HOTEL ACCOMMODATIONIf you have any queries about hotel accommodation, please visit the DIA Registration Desk in the first floor foyer.

INTERNET ACCESSWireless internet access is available for delegates throughout the CCD.

LOST AND FOUNDAll found items will be stored at the DIA Registration Desk until the end of the conference.

MOBILE APPDownload the Clinical Forum conference mobile apps for iPhone and Android. Search your app store for “DIA CF2013”. A mobile web version is also available through the Clinical Forum Website. See page 7 for instructions or ask for further information at the DIA booth in the Liffey Exhibition Hall on the first floor.

NETWORKING ZONEMeet up with delegates and fellows; expand your network and build new relationsips in the Networking Area in the Liffey Exhibition Hall on the first floor.

PRESS ENQUIRIESDIA Europe welcomes qualified representatives of news organisations for the purpose of reporting and publishing and broadcasting articles and stories. All media must present a copy of their press credentials upon arrival at the DIA Registration Desk. For more information, please contact Talana Bertschi on [email protected] or call +41 61 225 51 51.

PUBLIC TRANSPORT Dublin buses run from 06:00 – 23:30. A Nitelink late service operates most nights of the week. Dublin Bus operates an exact fare policy so it is advisable to have correct change ready when boarding. The Dublin Luas system is a light rail transit system with two lines, running from St Green to Sandyford and from Tallaght to Connolly Station. The closest stop is Spencer Dock, right behind the CCD.

REFRESHMENT BREAKSAll refreshment breaks will be served in the Liffey Exhibition Hall on the first floor. There are four catering stations at your disposal. Welcome coffees are available in the first floor foyer.

Tuesday08:00 – 09:00 Welcome Coffee10:30 – 11:00 Coffee Break12:30 – 14:00 Lunch15:30 – 16:00 Coffee Break17:30 – 19:30 Networking Reception

Wednesday08:00 – 09:00 Welcome Coffee10:30 – 11:00 Coffee Break12:30 – 14:00 Lunch15:30 – 16:00 Coffee Break

REGISTRATIONThe DIA Customer Services Team will be pleased to assist you with your conference registration, registration changes, group and one-day tickets, and general enquiries. Attendee, speaker and exhibitor registration are located in the first floor foyer.

Registration opening hours:Monday 15:00 – 18:00Tuesday 08:00 – 19:30Wednesday 08:00 – 17:30

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General Information A-Z

SECURITYWe take your safety seriously. Please help us by cooperating fully with the security personnel on duty and wear your badge at all times. Only participants with a valid conference badge will be allowed into the CCD first and second floor areas and to attend sessions.

SPEAKERS’ LOUNGE & SPEAKER PREVIEW ROOMSpeakers are encouraged to meet their session chair(s) in the Speakers’ Lounge, signposted and located in the Liffey Exhibition Hall (see floor plan on page 22). Speakers can pick up their refreshments from the buffets and meet with fellow speakers in the dedicated area while enjoying their refreshment break. The Speakers’ Lounge is reserved for speakers only and open throughout the conference.

Speakers are required to visit the Speaker Preview Room, which is equipped with computer workstations, to check or finalise their presentations before their sessions. The Speaker Preview Room is located in Liffey Meeting Room 1 on the first floor.

In the unlikely event that speakers have not provided their presentations in advance, they are requested to submit their presentations on a memory stick to the AV technician at least two hours before their session begins. The presentation files are managed in a closed offline network and will be uploaded directly to the relevant meeting room. Please note that alterations or uploads are only possible in the Speaker Preview Room and not in the session rooms.

Speaker Preview Room Opening Hours:Monday 15:00 – 18:00Tuesday 08:00 – 17:30Wednesday 08:00 – 16:10

We advise that speakers arrive at their assigned meeting room 15 minutes prior to the starting time of their session. Upon arrival, they must confirm that their final presentation is uploaded on the presentation laptop. It is strongly recommended that speakers bring a back-up copy of their presentation with them on a USB stick in case of emergency.

PRESENTATIONSRegistered participants will be able to download presentations from Friday, 18 October 2013. Log in to My DIA and click on My Presentation Downloads to see all presentations that have been made available.

TOURIST INFORMATIONGeneral tourist information, maps and information about other events in Dublin are available at the registration desk. Please help yourself! The Discover Ireland information offices are located at Airport terminals 1 & 2, on Suffolk Street (former church of St Andrew just off Grafton Street) and on O’Connell Street (two doors from the Savoy cinema).

Discover Ireland Suffolk Street opening hours:Monday-Saturday: 09:00 – 17:30 Sunday & Bank Holiday: 10:30 – 15:00Discover Ireland O’Connell Street opening hours:Monday-Saturday 09:00 – 17:00

For further information, visit http://www.visitdublin.com/ or call 1850 230 330 (within Ireland).

TWITTERTweet about the Clinical Forum using #DIA_CF and @DIA_Europe

Clinical Forum App for iPhone and Android!

The mobile app will enrich your experience before and during your time at the meeting. Stay organised and keep abreast of all the latest information available. Free mobile apps are available for Android™, iPhone® and iPad®/iPod Touch® as well as for mobile web.

Installation instructions:• Go to your Apple App Store, or Google Play Store, depending on the device you are using, and search for “DIA CF2013” • Download and install the app • Log in using the the email address used for your Clinical Forum registration • You’re ready to go!

The Clinical Forum App allows you to:• Create Your Agenda • Browse by theme, date or session number • Use the search function, if you already know a bit about what you want to see • View the “My Profile” area • The “My Schedule” area displays all of the sessions that you have chosen to “Add to my Schedule” • View appointments that you have made with other attendees • Review and respond to messages that attendees have sent you • Keep information about exhibitors handy in the “To Do List” • ...and more

Receive News and Announcements • Event information • Programme updates • Networking events

Network • Exchange messages with attendees • Set up appointments with other participants and create personal calendars • View the current list of exhibitors

CliniCalForum

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DIA Europe promotes the participation of Students and Young Professionals in the annual Clinical Forum by offering up to 25 complimentary

registrations to attend the 2013 meeting. The Fellowship Programme is designed to allow selected fellows to gain their first experiences at a

large international conference, to find out more about the sector they will be working in, and to foster exchange between the different groups

of stakeholders.

• Develop collaboration and improve alliances with different stakeholders

• Increase knowledge of issues at the heart of patient-centred healthcare

• Provide insight into the use of clinical trials by the pharmaceutical industry and regulatory authorities

• Enhance the capacity to respond to changes in drug development and healthcare delivery

• Stimulate mutual understanding and cross-cultural co-operation, share best practices, and act as a platform for knowledge exchange and

networking

Student Fellowship 2013 participants• Jorge Batista, University of Algarve, Faculty of Sciences and Technology, Portugal

• Ana Paula Cancino, Universite Claude Bernard Lyon 1, France

• Heidi Guldborg Moller, Aalrg University, Denmark

• Clement Haeck, University of Lille 2, France

• Faidra Kalakou, University of Copenhagen, Denmark

• Marina Knezovic, Faculty of Pharmacy and Biochemistry, Croatia

• Alexandra Lupou, Iuliu Hatieganu University of Medicine & Pharmacy, Romania

• Carlos Neto, Faculty of Pharmacy, University of Lisbon, Portugal

• Ana-Maria Oltean, Iuliu Hatieganu University of Medicine & Pharmacy, Romania

• Rui Saldanha, Faculty of Pharmacy, University of Lisbon, Portugal

• Eva Shannon Schiffrer, University of Ljubljana, Faculty of Pharmacy, Slovenia

• Rasa Starselskyte, Lithuanian University of Health Sciences, Lithuania

• Gabriella Valentova, Charles University, Czech Republic

Young Professional Fellowship 2013 participants• Andre Andrade, Novartis Farma, Portugal

• Andreea-Raluca Ghinea, Paraxel International Romania SRL, Romania

• Anne Jensen, NordicBioScience, Denmark

• Ellina Kovalenko Allais, Aixial RC, France

• Jessica Krause, Phamacist, Germany

• Linda Nguyen, Medcomm Solutions, USA

• Nenad Radjenovic, Quintiles, Serbia

• Andra Maria Stanescu, Pfizer Romania, Romania

• Kimmie Udengaard, Nordic Bioscience, Denmark

• Celia Wilson, GlaxoSmithKline, UK

Dia StuDent anD Young ProFeSionalS FelloWSHiP Programme in DuBlin

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STuDEnT anD YounG ProFESSional PrE-ConFErEnCE

HoTEl Clarion | monDaY, 7 oCToBEr 2013 | 14:00 – 15:30

WELCOME TO MY WORLD – A DAY IN THE LIFE OF CLINICAL FORUM PROFESSIONALSSession Chair: Aaron Cockell, Medical Information Regional Director, EMEA, Pfizer Inc., UK

Clinical professionals from different fields will be talking about their daily work and answering questions. The session has a cross-cultural element and speakers represent different working cultures. The aim is to help young delegates better understand the day to day working lives of the people who attend the Clinical Forum and ease the way to networking with experienced professionals.

Myth and Reality of Intercultural WorkingJens Reinhold, Medical Director ZAO Bayer, Bayer Healthcare Pharmaceuticals Russia, Russian Federation

What Does CDM Do?Johann Pröve, Global Head, Data Management, Bayer Healthcare, Germany

Look Where It Can Take You!Mary Gardner Stewart, Divisional Director, Medical Documentation, H. Lundbeck A/S, Denmark

14th DIA Conference on European Electronic Document Management (eDM)A Story of Rejuvenation

Event #1311020–22 November 2013DoubleTree Dublin Hotel, Dublin, Ireland(formerly The Burlington Hotel)

visit www.diahome.org/euEDM2013 for more information

Students and Young Professionals, you are invited to a Networking Reception for a drink from 17:00 – 18:00!Location to be confirmed onsite, and during session.

After the reception, why not join DIA members and volunteers for a pre-conference Gathering on Monday, 7 October 2013 from 18:30 at The Doheny & Nesbitt, otherwise known as the “Doheny & Nesbitt School of Economics”. Breffni Martin will be hosting this unofficial welcome get-together and will share local insights to Dublin (www.dohenyandnesbitts.ie).

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HoTEl Clarion | monDaY, 7 oCToBEr 2013 | 14:00 – 17:30Workshop 1

THE CLINICAL TRIALS TRANSFORMATION INITIATIVEInstructors:Pamela Tenaerts, Executive Director, Clinical Trials Transformation Initiative, USAFergus Sweeney, Head of Sector, Compliance and Inspection, European Medicines Agency, European Union

The Clinical Trials Transformation Initiative: A public private partnership whose mission is to identify and promote practices to improve quality and efficiency of clinical trials.

Overview1. CTTI General Overview

• History • Organisational overview • Methodology• Portfolio

2. Selected CTTI projects and recommendations • Safety reporting• Central Institutional Review Board (IRB)• Monitoring

3. Quality by Design (QbD), applied for Clinical Trials• What are the key drivers for quality?• Quality Risk Assessment and Quality by Design – principles not

jargon• Regulatory requirements for ensuring quality: a European

perspective• Real world example• Review and discuss the Principles Document

Break-out Groups • Working in groups, participants will apply the Quality by Design

principles to their hypothetical protocol outline, taking into account the concerns of key stakeholders

• Select the top 5 factors that are critical to the success and quality of the trial protocol and why they are important

• Develop 3 priority recommendations to assure a successful and efficient trial

• Report out session – Lessons learned and next steps

Learning Objectives• Develop understanding of completed CTTI projects and their

recommendations• Develop understanding of risk-based Quality by Design for clinical trials

from general principles, real-world examples, and hypothetical case studies

• Gain confidence in the application of building quality into the clinical trials processes

• Identify perceived barriers and potential solutions to the adoption of Quality Risk Management

• Identify opportunities for dissemination of Quality by Design principles and practices to a broad array of stakeholders in your organisation

Target Audience• Representatives from a broad cross-section of the clinical trial

enterprise, including regulators, government sponsors of clinical research, academia, industry, patient advocates, clinical investigators, and other interested parties

• Participants are expected to be actively engaged in dialogue

PrE-ConFErEnCE WorKSHoPS

Workshop 2

ELECTRONIC ARCHIVES ARE NOT YOUR SYSTEM BACKUP MEDIAInstructor:Teri Stokes, Director, GXP International, USA

Retention for study records today includes electronic CRFs and electronic source data at the sites as well as in the sponsor’s Trial Master File. Proper indexing and handling of media for long term retention is new to many investigator study teams.

This workshop builds awareness for e-archive practices needed to preserve electronic raw data from studies. The need to recreate study results from long retained data is a regulatory requirement for GCP trials. System backup media do not constitute an electronic archive. There is a science to good archive practices in this workshop we explore them.

OverviewI. Defining the purpose, scope, and structure of an electronic archive • What is an electronic archive and why is backup media not an

electronic archive?• What is the OECD guidance approach to archiving and electronic

archives?• Analysis of SOP topics from OECD for establishing an archive• Defining the role of the archivist vis-à-vis the IT function

supporting an electronic archive

II. Archiving Principles, Archivist Values, and The Electronic Document Difference

• Provenance, Original Order, Indexing, and Catalogue• Record collection and retention values and best practices• Scale, Mutability, and Readability• Needs analysis for planning a long term retention requirements

specification

III. Interactive Exercise• Archivist Team: Discuss and document a hypothetical “AS IS”

analysis report of your group’s companies using the requirements specification section of Chapter 9, pp 303-304.

• IT Team: Discuss a hypothetical plan for IT to use to design the infrastructure for an e-archive in a small to medium company using the 13 points quoted in Chapter 9, pp 305-307.

• QA Audit Team: Discuss the OECD topics for Archival SOPs. 1. Decide how these should apply to archive staff and also to IT

staff. 2. What quality evidence will you look for in an audit of an

electronic archive for each department based on this SOP framework?

Learning Objectives• Differentiate the roles for system backups versus electronic archives• Describe the archivist principles for data preservation• Know the non-IT practices for building and managing an electronic

archive

Workshop Material:• Chapter 9: The Archivist Role for Electronic Archives in Teri Stokes

“Computer Validation: A Common Sense Guide”. • Organisation for Economic Cooperation and Development (OECD) 2007

Guidance – “Establishment and Control of Archives that Operate in Compliance with the Principles of GLP”

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CroSS-FunCTional SESSion

09:00 – 10:30 RISK-BASED MONITORING – PART ISession Chair: Estrella Garcia, Head of Global Clinical Operations, Almirall S.A., Spain

Risk-Based Monitoring – The GCP Inspector’s point of viewCatharine Raitt, GCP Inspector, Medicines and Healthcare products Regulatory Agency (MHRA), UK

Transition from a Traditional Monitoring Strategy Towards a Risk-Based Monitoring Approach: Key learnings and challengesIdoia Herrero, Clinical Trial Manager, Almirall S.A., Spain

Evolution on Trial Management Under a Risk Based Monitoring ApproachCrona Ann O’Conallain, Director, Global Data and Safety Monitoring, Quintiles Ireland Ltd, Ireland

Panel discussion

11:00 – 12:30 RISK-BASED MONITORING – PART IISession Chair:Julianne Hull, CEO, WenStar Enterprises, UK

A Holistic Approach to Monitoring Clinical TrialsPeter Schiemann, Managing Partner, Widler & Schiemann Ltd, Switzerland

Identifying Atypical Sites with Central Statistical MonitoringErik Doffagne, Biostatistician, CluePoints, Belgium

Lessons from Risk-Based MonitoringMassimo Barbato, Director, Medidata Solutions Worldwide, UK

Panel discussion

PlEnarY SESSionTUESDAY, 8 OCTOBER 2013 | 14:00 – 15:30 | WICKLOW HALL 2A+2B

Welcome AddressJytte Lyngvig, Director, DIA Europe, SwitzerlandDetlef Nehrdich, Programme Chair, Senior Associate, Waife & Associates, Inc., Germany

Plenary DebateTHIS HOUSE BELIEVES THAT IN TEN YEARS THERE WILL BE NO CLINICAL TRIAL OPERATIONS STAFF IN EUROPEModerator:Julianne Hull, CEO, WenStar Enterprises, UK

Four industry experts will use the adversarial Oxford Style to debate this controversial topic. In an economically pressurised world is Europe really the place to perform valuable clinical research? With the critical consideration of patient safety and data integrity first, is it worth the risk to shift the majority of clinical research to the still emerging economies? This cross-functional plenary session will be an exciting highlight as we seek to reboot clinical research.

Debaters:Dermot Kenny, Vice President Data Management, ICON Clinical Research, IrelandSheila Kiss, Senior Vice President, Quintiles, UKGail Kniveton, Managing Director, POP Science, UKNick Lucas, Vice President Implementation Services, Medidata Solutions Worldwide, UK

RISK-BASED MONITORING – CROSS-FUNCTIONAL SESSION IN TWO PARTS WEDNESDAY | 9 OCTOBER 2013 | 09:00 – 12:30 | WICKLOW HALL 2A

RBM offers sponsors and regulators opportunities and quality improvements, but are pharma, CROs and technology providers ready to undertake the new challenges? How well are we prepared to implement such an initiative? We will hear from regulators, pharma industry and lead CROs how the new paradigm in clinical trial management has implemented this new approach and study data compliance supervision.

Lessons learned from initial experiences will be shared and discussed with the audience.

In the second part of the session a more holistic approach on how to ensure we have reliable clinical data will be taken. Both parts of this special session will include a panel discussion.

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TUESDAY | 8 OCTOBER 2013

09:00 – 10:30 Session 0101 | Liffey Hall 1

TRANSPARENCY FROM CLINICAL TRIALSSession Chair:Fergus Sweeney, Head of Sector, Compliance and Inspection, European Medicines Agency, European Union

For the clinical trials community, requests about clinical research data transparency are likely to have the most crucial impact in the near future. Different stakeholders have requested open access, be it in the name of good science, for preparation of health technology assessments or patient information purposes. Currently, regulations and policies are being developed by the authorities, industry associations and medical journal editors, in an atmosphere that has become febrile within the past months.

The session will focus on the patient information aspects of trial data transparency. Approaches for patient-centered communication will be presented, all of them embedded in a practical discussion on the latest transparency developments such as the draft EMA policy, the current EFPIA statement and other national reporting obligations.

Clinical Trial Disclosure: Utilising regulatory obligations for patient communicationHolger Maria Rohde, Medical Operations Officer, TEVA Pharma GmbH, Germany

Patients’ Needs for Information about Clinical Trials in Lay Language and in National LanguageSusanne Jena, Project Manager, University Medical Center Freiburg, Germany

Are Clinical Trials Data Transparency and Patient Privacy Mutually exclusive?Pierre-Yves Lastic, Associate Vice-President, Chief Privacy Officer, Sanofi, France


PATIENT RECRUITMENT AND RETENTION IN CLINICAL TRIALSSession Chair:Liz Moench, President & CEO, MediciGlobal, Inc., UK

The rapid growth of ePharma consumers (patients seeking health information) has created new opportunities to tap into well-defined online patient communications channels for both pharmaceutical clinical researchers and marketing professionals. Patient recruiters and pharmaceutical marketers now compete for the attention of the same ePharma consumers. These consumers in turn are able to more easily assess their choices online, in terms of available treatment and clinical trials.

The internet offers widespread access to health information, affording patients the advantages of interactivity, information exchange and anonymity. Today, social networking sites and online patient communities are proving fertile ground for people seeking peer-to-peer social support, empowering one another

and connecting with clinical trials. This session will explore how new online approaches to planning, implementing and measurement with the patient as its central focus are changing the way in which cutting edge patient recruitment is being conducted today.

Patient Centricity: A major driving factor of clinical innovationLiz Moench, President & CEO, MediciGlobal, Inc., UK

How Online, Patient-Centric Systems and Processes will Transform Clinical TrialsKai P. Langel, Principal Consultant, eClinicalHealth, Finland

Standard Practices and Policies to Optimise the Value and Manage the Risk of Social Media Communities in Clinical ResearchStella Stergiopoulos, Project Manager, Tufts Centre for the study of Drug Development, USA

14:00 – 15:30 Session 3 PLENARY | Wicklow Hall 2A+2B

See page 11 for details


IMPROVING CLINICAL DEVELOPMENT PERFORMANCESession Chair:Estrella Garcia, Head of Global Clinical Operations, Almirall S.A., Spain

Clinical development expenditures and ratio of success is increasing exponentially. Now the cost of developing a new molecule is considered some 2 billion dollars. In this very competitive arena, we need to be even more efficient than in the past. This is why there are several initiatives across the industry and within each industry to simplify and improve the efficiency in managing clinical developments, and in particular clinical trials process.

We will have the opportunity to hear about the TransCelerate Initiative and other standardisation processes that are sure to improve pharma industry performance.

TransCelerate as an Industry Driven Performance Initiative – Start-up, launch and year oneKathleen Ford, SVP – Head of Global Clinical Operations, Merck KGaA, Germany

Position Paper “Life-cycle and Management of Protocol Deviations”Katharina Kurpanek, Managing Director, The QM Company, Belgium

Clinical Development Optimisation through Structured and Standardised Study Design Djenan Ganic, Senior Consultant, Life Science, NNIT Switzerland AG, Switzerland

WEDNESDAY | 9 OCTOBER 2013

09:00 – 10:30 Session 0105 | Wicklow Hall 2A

RISK-BASED MONITORING – PART I



RISK-BASED MONITORING – PART II



HEALTH ECONOMICS OUTCOME RESEARCH (HEOR)Session Chair:Markus Hartmann, Principal Consultant, European Consulting & Contracting in Oncology, Germany

HTA bodies but also regulatory authorities nowadays start to ask for effectiveness data available for their early benefit-risk assessment. Clinical operations must cope with these expectations; the generation of health economics outcome data should hence already begin in the pre-authorisation phase. In this session, perspectives will be presented, how industry may respond to this demand through early and effective interactions with patients, regulators and, last but not least, HTA bodies and payers.

Theme 1 | Clinical OperationsTheme LeadersEstrella Garcia, Head of Global Clinical Operations, Almirall S.A., Spain Holger Maria Rohde, Medical Operations Officer, TEVA Pharma GmbH, Germany

The evolving regulatory and technology landscape in clinical development is becoming more and more challenging.The Clinical Operations Theme will discuss several initiatives, how they are affecting the efficiency and management of clinical trials. Among others how the Risk-Based Monitoring Approach is being implemented by the industry, how health economy evaluation dossiers are considered in clinical development plans and how virtual communities are being implemented in overall trial management.Finally, patients’ involvement and performance in clinical trials is key to success. New approaches on how to inform, involve, maintain and monitor them will be presented.

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NEW TECHNOLOGIES TO REBOOT CLINICAL TRIALS – PART IISession Chair:Rolf Banholzer, Development QA Systems and Standards, Global Head GxP IT Systems & Processes Novartis Pharma AG, Switzerland

Computer System Validation and Technology has been and is still seen as a resource-intensive and time-consuming task, rather a threat than an enabler of the business. It is perceived as a “technical challenge” to be dealt with and executed by an IT department, despite the fact that we have learned that many key risks are with the critical Clinical and Pharmacovigilance processes and data itself. Technology enables the business to manage and execute processes in an efficient and compliant way.

In this session, we discuss new approaches to Computer System Validation, but also share ideas on validating data quality and data integrity using e-tools monitoring centrally available data for early detection of incomplete and potentially false data.

Test Script-Free Validation in a Regulated Environment: Kanban styleAndy Ross Glover, Head of Testing, Exco Intouch, UK

Finding Protocol Violations and Safety Confounders – A new tool introducedMalin Jakobsson, Product Manager, Uppsala Monitoring Centre, Sweden

Sanofi’s Integrated Tool for the Study OversightCécile Labeirie, Senior Clinical Trial Operation Manager (CTOM) – Oncology, Trial Operations, Clinical Sciences & Operations, R&D Sanofi, France




CLINICAL DATA STANDARDS: YOUR QUALITY ENABLER!Session Chair:Pierre-Yves Lastic, Associate Vice-President, Chief Privacy Officer, Sanofi, France

Producing quality clinical study results within the shortest possible time is the clinical development Holy Grail. One of the most critical aspects of this process is the establishment and maintenance of robust clinical data standards. In this session our speakers will propose strategies to achieve this ambitious goal.

CDISC Standards UpdatePierre-Yves Lastic, Associate Vice-President, Chief Privacy Officer, Sanofi, France

Managing Data as a Critical Business Asset: It starts at study set up with enforcement of data standardsIsabelle M. de Zegher, Worldwide Senior Director Clinical Data Standards, Perceptive Informatics, Belgium

Integrated Data and Metadata Validation Strategies from Source to SubmissionDimitri Kutsenko, entimo AG, Germany








Theme 2 | Technical OperationsTheme LeaderJulianne Hull, CEO, WenStar Enterprises, UK

Programme CommitteeRolf Banholzer, Development QA Systems and Standards, Global Head GxP IT Systems & Processes Novartis Pharma AG, Switzerland Graham Bunn, VP Partnerships, Perceptive Informatics, UKPierre-Yves Lastic, Associate Vice-President, Chief Privacy Officer, Sanofi, France Breffni Martin, Legal Representative, Optuminsight Strategic Regulatory Services, IrelandPeter Stokman, Head Global Data Management & Standards Oss, Merck Sharp and Dohme, the Netherlands

Encompassing CDM, eClinical, validation and technologies this theme aims to address the key aspects of technical operations throughout the lifecycle of a clinical development programme. Sessions and presentations will provide recent experience on: • Planning and implementation of risk-based monitoring• Really achieving a paperless clinical trial• Using technology to drive process and delivery optimisation• eSource, CDISC and ensuring real time data availability• Agile and script free validation• Cloud computing and the changing regulatory environment



NEW TECHNOLOGIES TO REBOOT CLINICAL TRIALS – PART ISession Chair:Graham Bunn, VP Partnerships, Perceptive Informatics, UK

As we all go about our day-to-day business of bringing New Chemical Entities (NCEs) to market faster it is often difficult to find time to stop, look up and discover what is new in the technology world that could help us reboot the way we all do our jobs. DIA has received feedback from attendees that they would like to see more vendor neutral presentations about the types of new technologies available and how they might help the industry take a fresh approach to clinical trials. For the next two sessions therefore the focus is technology however all speakers will discuss aspects of process around technology implementation to ensure the focus is rebooting trial efficiency – not technology for its own sake!

When Outsourcing – Technology and procedures around the technology are both importantNiki Kutac, Product Manager, Data Systems, DATATRAK International, USA

Minimising Reconciliation between Safety and Clinical DatabasesRicky Lakhani, Product Manager, Medidata Solutions Worldwide, UK

The Next Big Thing in Clinical Research – Patient engagementDouglas Bain, Founder and CEO, eClinicalHealth Limited, UK

Partnering with Patients: Designing, participating in, and reporting health outcomesJudith Teall, Director of Clinical Excellence, Exco InTouch, UK

The New Interface between Regulators and HTA Bodies: Common or divergent expectations for health outcomes data?Markus Hartmann, Principal Consultant, European Consulting & Contracting in Oncology, Germany

Collecting Clinical Data to meet Payers and HTA Bodies’ RequirementsSimone Breitkopf, Head Governmental Affairs and Pricing, Alcon Pharma GmbH, Germany

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Theme 3 | Medical AffairsTheme LeadersHeike Schön, Managing Director, LUMIS International, GermanyJens Reinhold, Medical Director ZAO Bayer, Bayer Healthcare Pharmaceuticals Russia, Russian Federation

Medical Affairs is the discipline combining concepts of clinical research and real-life healthcare requirements. It is the transformation of what was accomplished during the clinical trials and the approaches to meet market requirements. This often requires finding innovative ways of involving patients, of identifying new opportunities to gather data through innovative study approaches, e.g. virtual studies, and of bridging the pharmacovigilance requirements from clinical trial results to post marketing evaluations. These key topics will be addressed during the sessions and the theme will be topped off by experts reflecting on best approaches to delivering high value publications from clinical trials and post marketing studies.


09:00 – 10:30 Session 0301 | Liffey Meeting Room 5

POST-APPROVAL STUDIES AND VIRTUAL STUDIESSession Chair:Heike Schön, Managing Director, LUMIS International, Germany

Clinical Studies performed to collect knowledge about certain diseases, patient behaviour, and safety data or drug usage often involve large populations either globally or on a national scale.

These studies always need easy access to patients or physicians to collect the data. Innovative approaches have been developed over the years leading even into complete virtual approaches to involve patients directly. The session will provide further insight to organising registries and the needed legal framework. The session will share experience in managing virtual trials and how innovative approaches will shape complete research programs in post approval study design.

Patient Registries in Emerging MarketsSamyuktha Ajay, Director, Clinical Development, Sciformix, India

Direct-to-Patient Virtual Trials and Their Technologies – New lessons learned and appliedDavid B. Stein, Senior Director, Product Management, Perceptive Informatics, USA

Conducting Post-Approval Studies in a New Era: Innovation in delivering clinical research programmesKate Trainor, VP, Global Head Project Management & Technology, PAREXEL International, USA


MAXIMISING THE VALUE OF POST-APPROVAL STUDIES THROUGH PUBLICATION EXCELLENCESession Chair:Jens Reinhold, Medical Director ZAO Bayer, Bayer Healthcare Pharmaceuticals Russia, Russian Federation

Post-approval studies are extremely valuable tools to answer questions which could not be covered in clinical development programmes before approval and which can support the product on the market with new data on practical use, special patient populations, long-term use, and others. In Europe, post-approval studies become more and more a “routine” request of the regulators with regards to safety of new compounds and indications in real life. This session provides insight how real-life studies can be made a powerful tool for publication of new product knowledge using an intelligent publication strategy, including successful practical case examples.


THE SMART APPROACH TO ePROSession Chair:Breffni Martin, Legal Representative, Optuminsight Strategic Regulatory Services, Ireland

Today there are just over one billion smart phones on the planet used by just under one billion people. Of these, 89% keep the phone switched on 24/7. Smart phones can act as data capture devices, data delivery devices, and even as cybernetic biofeedback devices. They can not only capture and send audio, photo, video, and user inputs, but can also deliver audio, photo, video and other content yet they are mainly used for texting, games and social networking. Smart phones have come of age as ePRO/EDC devices and this session will explain why.

Moving with the Times: Mobile and smart phone use in ePRO Hannah O’Gorman, ePRO Specialist, Exco InTouch, UK

Benefits of a Unified EDC, ePRO and RTSM PlatformSimon Wilson, Subject Matter Expert, Clinical, ArisGlobal, UK

Billions and Billions of Smartphones; Why are we still using paper and eDiaries?Anne Zielinski, Global Lead Patient Cloud, Medidata Solutions Worldwide, UK


BENEFITS OF THE CLOUDSession Chair:Rolf Banholzer, Development QA Systems and Standards, Global Head GxP IT Systems & Processes Novartis Pharma AG, Switzerland

Cloud computing has been recognised by a wide population as an efficient, simple and successful solution for sharing and managing documents, music and pictures. Millions of people have cloud-based solutions installed on their smartphones and PCs. So why not copy such a successful concept into our highly regulated environment?

In this session, we discuss benefits, challenges and opportunities using global, cloud-based solutions enabling GCP/PV relevant processes with a high demand on data integrity, data privacy and data security.

Implementation and Delivering CDM Services on Cloud – Best practices and pitfallsAbhishek Bagga, Manager, Clinical Systems Center of Excellence, Cognizant Technology Solutions Corporation, India

Cost of Doing Business in the Cloud: A CRO/software vendor perspectiveSteve Tee, CTO, RealWorldEdc (CTEP), Ireland

eTMF in the Real Cloud – Improving your clinical processes and collaboration whilst optimising cost effectivenessRik Van Mol, Vice President Vault Strategy, Europe, Veeva Systems, Spain

Presentations will be available onlineRegistered participants will be able to download presentations from Friday, 18 October 2013.Log in to My DIA and click on My Presentation Downloads to see all presentations that have been made available.

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Integrated Publication Planning in Late-phase ResearchThomas Wagner, Medical Writing Manager, Trilogy Writing and Consulting GmbH, Germany

Nancy Vobecky, Director, Publications and Communications Global Medical Affairs Oncology BayerHealthcare Pharmaceuticals, USA




PHARMACOVIGILANCE – INNOVATION AND INTERFACESSession Chair:Joan Gilvarry, Director Human Products Monitoring, IMB, Ireland

The new EU pharmacovigilance legislation has introduced a robust and transparent system which aims to ensure a high level of public health protection throughout the EU. The legislation dictates a more proactive approach, not only to identify and evaluate potential safety issues, but also to minimise risks and promote the safe and effective use of medicines.

This is clearly necessary with the development of innovative products with as yet unknown safety profiles, which therefore require careful monitoring e.g. products based upon new technologies, such as biologics and gene therapy. To prove effective, pharmacovigilance systems need input from all stakeholders.

The legislation embeds Risk Management Plans (RMP) as a key tool in proactive pharmacovigilance. The RMP leads to the design of Risk Minimisation Measures (RMM’s) aimed at reducing or preventing the severity of adverse reaction associated with a medicinal product. Measuring the effectiveness of the RMM’s is an important aspect of continuous pharmacovigilance.

This session will provide insight into real situations of how the assessment of effectiveness can be integrated into the pharmacovigilance system and Pharmacovigilance from a Biotech start up company perspective.

Fitting the Jigsaw Puzzle Together – Leveraging the integrated approach for improved safety and quality outcomesNicole Baker, Associate Director, Customer Safety Services Europe, Quintiles, Ireland

How will Assessment of Effectiveness be Integrated into the Pharmacovigilance System?Brian Edwards, Principal Consultant Pharmacovigilance and Drug Safety, NDA Regulatory Science Ltd, UK

Pharmacovigilance in a Biotech Start-Up Company: Experiences from marketing the first ATMP in the EULudo Haazen, Qualified Person for Pharmacovigilance, TiGenix, Belgium









PATIENT CENTRED STUDIES – INNOVATIVE APPROACHES TO INCLUDEPATIENTSSession ChairKlaas Heinemann, Director, Zeg-Berlin GmbH, Germany

Strictly speaking, patients have almost always been at the centre of most clinical research. The ultimate aim is the enhancement of the health of human beings by effective prevention or treatment of diseases. However, the involvement of patients was traditionally restricted to the role of being subjects, i.e.: The logic behind the research, the design of studies in patients, the capturing of information, as well as the analysis of data, were all regarded as the domain of experts. This situation is changing rapidly. The contents of the session will address some aspects of the status of transition to increased direct participation/contribution of patients in the clinical research process.

Involving Patients in Design and Implementation of Patient-centred StudiesJan Geissler, Director, The European Patients’ Academy on Therapeutic Innovation (EUPATI), Belgium

Approaches to Direct and Long-term Patient Follow-up in Patient-centred StudiesKlaas Heinemann, Director, Zeg-Berlin GmbH, Germany

Integrating Dual Source Information: Lessons from sexual medicine and pair therapyAlfred Pauls, Consultant, Charité University Medicine, Germany

Biosimilars Workshop - European experiences and challenges

21-22 November 2013DoubleTree Dublin Hotel, Dublin, Ireland(formerly The Burlington Hotel)Event #13109

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TRANSLATING DATA INTO INSIGHTS Session Chair:Lillian Auberson, Senior Director, Global Medical Information, Novartis Pharma AG, Switzerland

The Head of a medical information group once said to me that he wished his monthly activity reports sent to internal stakeholders could better relay the richness and complexity of daily interactions with customers, as well as the insights about products gained through unsolicited inquiries. As medical information professionals, we know our data and the challenge is how do we create real insights beyond the mundane product categories, inquiries numbers, response times, etc.

Having said that, the mundane may not be so mundane after all, as it is an attempt to organise information for trending analyses. The value of a medical information department hinges on the ability to discover and convey real insights gained through front-line interaction with customers. In this session, we will explore how two companies are transforming data into actionable insights that create business value and thus reinforces the strategic function of medical information within an organisation. Session 2 is the follow-up of Session 1, and we will explore how to actively communicate and market the value of medical information.

Tangible and Intangibles Insights; Connecting the dots...Ros O’Callaghan, Medical Information Director, Europe, Bristol-Myers Squibb Pharmaceuticals, UK

Insights from a Retrospective Analysis of Medical Inquiries in Italy over 9 Years – How we created valueElisabetta Speroni, Medical Information and Communication Head, Novartis Pharma, Italy


PROVE YOUR VALUE! MARKETING MEDICAL INFORMATIONSession Chair: Sharon Leighton, Consultant, Sharon Leighton Consultancy Ltd, UK

As we have become more successful at identifying and understanding our value proposition, we need to be smarter about communicating that value. Using an actual case study, this facilitated workshop will help you:• Identify different ways that you and your teams can more effectively

communicate your value to stakeholders, senior management and customers• Have a clear marketing strategy and tactics that fit with your company culture

Even if your company doesn’t allow team branding, logos and marketing materials, you can learn about stealth tactics to stay on the business critical pathway!

The UCB Experience – Recent highlights from a US based medical information teamChristi Marsh, Director US Medical Information Medical Affairs, UCB Inc., USA


NEW EU PHARMACOVIGILANCE LEGISLATION AND THE IMPACT ON MEDICAL INFORMATION Session Chair:Janet Davies, Director, Medical Information & Medical Affairs Project Management, EAME, Gilead Sciences, UK

The new pharmacovigilance legislation has been said to represent the biggest change in pharmaceutical legislation since 1995, or even longer. This session will look at the impact of these changes and explore how medical information is rising to the challenges of implementation. There are uncertainties relating to off-label questions and analysis of medical information requests for PSURs. The increased access to safety information may result in increased volumes of questions to medical information departments.

The session will explore the practical challenges and experiences of implementing the legislation.

Impact of the Revised Legislation on Regulatory Communications Niamh Arthur, Pharmacovigilance Manager, IMB, Ireland

Points to Consider when Implementing EU Pharmacovigilance (PV) Legislation in Medical Information Sarah Hall, Medical Information & Pharmacovigilance Manager, Takeda UK Ltd, UK

Practical Experience in Implementing EU Pharmacovigilance (PV) Legislation in Medical InformationMonika Benker, Director Medical Information, Bristol-Myers Squibb, Germany


MI QUALITYSession Chair:Stephane Gamboni, Medical Scientist Urology/Oncology, Global Medical AffairsFerring International Centre S.A., Switzerland

High quality standards are crucial in medical information, because misinformation or poor information may expose healthcare professionals and patients to potentially serious consequences. Besides theoretical considerations, this session will focus on practical examples illustrating how quality standards can be developed and maintained. The attention of the audience will also be drawn to some insight into what healthcare professionals expect from responses to medical queries, given that meeting their expectations is a key component of quality.

The Iterative Steps Involved In the Development of Scientifically Accurate MI DeliverablesStefan Courtney, Medical Information Officer, Vifor Pharma UK Ltd, UK

Theme 4 | Medical InformationTheme LeadersAaron Cockell, Medical Information Regional Director, EMEA, Pfizer Inc., UKJanet Davies, Director, Medical Information & Medical Affairs Project Management, EAME, Gilead Sciences, UK

The European Medical Information and Communication Conference takes place as part of the annual DIA Clinical Forum. We are in the seventh year of this unique meeting organised by medical information professionals specifically for medical information professionals. Each year, speakers share hands-on experience on dealing with current challenges as well as successes in medical information departments. Participants are encouraged to take part in workshops and discussions within the sessions. This year, our themes are:

• The value of medical information• PV legislation• Evidence based medicine and MI• MI quality• Medical information in emerging markets• Regional and global management aspects• Technology and social media• Putting theory into practice

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Improving Medical Information Written Responses – Views from UK healthcare professionalsJayne Packham, Managing Director, Jayne Packham Consultancy Limited, UK



EMERGING MARKETSSession Chair:Ainhoa Del Romero, Director International Medical Information, International Scientific Affairs, Amgen (EUROPE) GmbH, Switzerland

As the pharmaceutical industry pins its hopes on strong growth in the emerging markets like Brazil, Russia, India and China, this session will explore the relevance of this shift in focus from US and Europe to new territories, regions and cultures. What can we learn from these dynamic markets? Are customers’ needs truly global or are there significant differences? Is Medical Information up to speed with meeting the needs of customers from those new markets? How do we address language, local regulations’ requirements and time zones issues?

How do we ensure quality? How can we collaborate more effectively with colleagues from emerging markets? Are we still trying to reproduce the same medical information models that we have in the US and Europe or should we start thinking out of the box?

How Medical Information can add value to Pharmerging Markets? The Brazilian and Russian modelsAna Xavier-Albuquerque, Medical Information Manager Brazil, Amgen, BrazilDmitry Seleznev, Medical Information Manager Russia, Amgen, Russian Federation Benefits and Challenges of a Global Medical Information Model in Emerging Markets Robyn Rennick, Director Medical Information EMAP, GlaxoSmithKline, UKMaitri Shah, General Manager, Medical Services, GlaxoSmithKline, UK


REGIONAL AND GLOBAL MANAGEMENT ASPECTSSession Chair: Isabelle Widmer, Independent Consultant, Switzerland

The more things change, the more they stay the same – or do they? Ever increasingly companies are exploring ways to develop their Medical Information function, including centralised, decentralised, and regionalised models or even, in some cases, one person balancing global responsibilities on their shoulders like the Greek god Atlas. As the Medical Information function evolves it is becoming clear that one size doesn’t fit all and consequently there are now almost as many Medical Information models, and permutations there-of, as there are companies! This session will explore diverse aspects of globalisation and regionalisation including virtual teams, global/local content development, useful tools, lessons learnt and emerging themes.

Globalisation of Medical Information – One size does not fit allManuel Espinosa, Associate Director, Global Medical Information, Novartis Oncology, USA

A Journey to Harmonise Medical Information DeliverySarah Dunnett, Senior Medical Affairs Manager, Baxter Healthcare Ltd, UK

MI Globalisation - A regional frontline perspectiveJoanne Gibson, MCI Team Leader, Director, Pfizer, UK


TECHNOLOGY AND SOCIAL MEDIASession Chair:Sangeetha Anand, Global Medical Information Senior Manager, Vifor Pharma Ltd, Switzerland

Not so long ago, desktop computing was a rarity, a new technology in itself. Just like mobiles were never needed before… could you live without your mobile phone now? Those who are growing up today with social media and today’s new technologies are tomorrow’s future. Jumping on the “technology and social media band-wagon” seems like a daunting prospect in a highly regulated world. In this session you will hear the stories of those that have and are braving this new world and aiming to provide customers with the fast access information they need, when they want it.

Innovations in Medical Information DeliveryChristopher Rains, Senior Director, LOC Medical Information, Shire, SwitzerlandThomas Wells, Senior Director, Medical Customer Engagement, Shire, USA

Development of a Medical Information Application to Capture HCP Queries Using the iPAD Clare Jordan, Medical Information Adviser and MI accountable, Roche, Ireland

Real Time Medical Information: First steps towards a worldwide roll-outPauline Frank, Global Head, Medical Information, Integrated Medical Services, GMA & HEOR, Novartis Pharma AG, Switzerland


THEORY INTO PRACTICESession Chair:Sarah Dunnett, Senior Medical Affairs Manager, Baxter Healthcare Ltd, UK

During this dynamic session, we will gain valuable insights to a diverse range of five initiatives from across our MI network. MI professionals will share their first-hand experiences in overcoming specific challenges, applying novel technology solutions and advancing their teams and processes to deliver even greater value for their companies and, of course, for patients. Our speakers will share the highs and lows of their project pathways and their learnings along the way – we are confident that every delegate will pick up many fresh ideas to take back with them.

Training 30 Countries on a Global Cross-Functional System: Highs, lows and InsightsLynne Love, Senior Manager Operations, Medical Information, European Scientific Affairs, Amgen, UK

Streamlining the Process of Escalation of Medical Information QuestionsSandra Tsai, Medical Scientist, Ferring Pharmaceuticals, Switzerland

Development and Launching a UK Medical Information WebsiteAshish Patel, Senior Medical Information Associate, Gilead Sciences, UK

Differentiated Enquiry Research and Service LevelsStefne Pienaar, Pfzier, Pfizer MI Area Lead Western Europe, Pfizer, UK

Insight to the Development, Management and Use of ‘SPOK’ (A cross-functionalKnowledge Management System)Murat Hamzakadi, Medical Advisor, Medical Information, Baxter, Germany


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There are many challenges involved in producing a high quality, compliant RMP, not least in the production of the newly legislated Section VI (summary for the lay reader). This session draws on the experience of three speakers, who will discuss different aspects of the challenges posed by the new RMP; from an industry perspective, through to the difficulties of writing for the general public, and a comparison of the EU RMP with its US equivalent, the “REMS”. Following the presentations, there will be a panel discussion during which specific questions and issues can be discussed, and participants will be encouraged to share their experiences, with the goal of identifying as a group some useful tips on how to overcome the challenges raised by the new RMP.

An Industry Regulatory Perspective on Applying the New Legislation and TemplateLambert A.J.M. Creuwels, Senior Medical Safety Adviser, H. Lundbeck A/S,the Netherlands

Addressing the Specific Challenges of Writing the New Lay Summary (Section VI) of the RMPLisa Chamberlain James, Senior Partner, Trilogy Writing & Consulting GmbH, Germany

The EU RMP Compared with the US REMS Madhu Davies, Consultant in Pharmaceutical Medicine and Devices, UK

14:00 – 15:30 Session 3 PLENARY | WICKLOW HALL 2A+2B


16:00 – 17:30 Session 0504 | Wicklow Hall 2B

CLINICAL TRIAL REGISTRIESSession Chair: Hanns-Georg Leimer, Head of Processes and Systems Coordination in Corporate Quality, Regulatory, Pharmacovigilance, Epidemiology (QRPE) incl. Clinical Trial Information Disclosure (CTID), Boehringer Ingelheim Pharma GmbH & Co. KG, Germany

The EU Clinical Trials Register has been available since March 2011. Publication of result-related information in Europe will start with the availability of EudraCT Version 9, which is scheduled for October 2013. For compliant, efficient, and consistent registration and results information across registries, it is essential that protocols, analyses, result synopses, and reports of clinical studies are “disclosure ready” and integrated in the publication plan. In addition, study results will be made available via the EU Clinical Trials Register prior to approval, which is a paradigm change for stakeholders.

EudraCT V9 – Publication of result-related information in Europe, regulatory perspective Fergus Sweeney, Head of Sector, Compliance and Inspection, European Medicines Agency, EU

Writing Study Protocols and Reports “Disclosure Ready”Doug Rush, Disclosure Specialist, Clinical Trials Transparency, Xogene Services, USA

EudraCT V9 – What to expect, an industry perspective Neil Newman, Business Consultant and Team Lead, Lilly UK, UK



IMPLICATIONS OF THE NEW PHARMACOVIGILANCE LEGISLATIONSession Chair: Deirdre McCarthy, Director, Lifecycle Safety, Quintiles Ireland

The new EU PV legislation represents the biggest change to medicines legislation in over a decade. Heralding a more holistic approach to safety management, with a focus on an integrated benefit-risk assessment, the legislation has had a major impact on aggregate reporting such as PSURs and EU-RMPs. This session will address key aspects of the rationale for the new legislation, the overlap between various aggregate safety reports in the current legislative framework as well as experiences to date with aggregate reports.

Overview of New EU Legislative Framework – Rationale for PSUR and RMP revamp Deirdre McCarthy, Director, Lifecycle Safety, Quintiles Ireland, Ireland

Interconnection between the Different Safety Documents in the New Pharmacovigilance Regulatory EnvironmentVeronique Basch, Executive Director, Global Pharmacovigilance, United BioSource Corporation, Switzerland

The New Aggregate Safety Reports: How are we doing? Brian Edwards, Principal Consultant Pharmacovigilance and Drug Safety, NDA Regulatory Science Ltd, UK


RISK MANAGEMENT PLANSSession Chair:Lisa Chamberlain James, Senior Partner, Trilogy Writing & Consulting GmbH, Germany

Safety documentation is far more than a description of adverse events received during a certain period and their implication for the product’s licence. The new pharmacovigilance legislation represents the biggest change to the regulation of human medicines since 1995, and calls for increased transparency and a far greater focus on the discussion and explanation of benefit versus risk. With this in mind, the Risk Management Plan (RMP) is the cause of much discussion in the industry and is currently a very hot topic.

Theme 5 | Medical WritingTheme LeadersMary Gardner Stewart, Divisional Director, Medical Documentation, H. Lundbeck A/S, Denmark Sandra Hecker, US Agent, Regulatory Consultant, Hecker & Associates, LLC, USA

The Medical Writing sessions will focus on the current hot topics within Medical Writing. These topics include the implications and impact of the new EU pharmacovigilance guidelines on various safety documents, including risk management plans (RMPs); an update on current issues related to clinical trial registries, including a heads up on what to expect with the coming EudraCT V9 and keeping registry postings in mind when preparing protocols and clinical study reports; regional considerations for global submissions, with particular focus on Asia; storyline documents (for example, briefing or regulatory response documents) for use in pre-submission meetings and non-guidance driven interactions with the regulatory authorities; submission challenges, including managing multiple indications and sharing of best practices for the response process for eCTD questions in the EU; and sharing of best practices on how to successfully handle the often difficult review process.

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REGIONAL CONSIDERATIONSSession Chair:Mary Gardner Stewart, Divisional Director, Medical Documentation, H. Lundbeck A/S, Denmark

Marketing Authorisation Applications (MAAs) have typically focussed initially on Europe and the US, and occasionally Japan. These are also the regions responsible for the ICH guidelines. But now the pharmaceutical industry is already thinking globally in the early stages of drug development. So what do sponsors need to know to navigate through the myriad regulations so that clinical development programmes are designed to address these regional differences from the outset? What documentation is required for countries and regions outside the ICH regions? And for smaller markets, what should the export dossiers contain so that the submission is acceptable for approval without compromising the confidentiality of the sponsor’s data?

Bridging Study Waiver and Subgroup Analysis Reports for Regulatory Submissions in Asian CountriesKirsten Herbach, Team Leader Medical Writing Europe/Senior Medical Writer, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany

Approval of New Drugs in India – A bird’s eye viewDivya K. Bhati, Research Scholar, Institute of Health Management Research (IIHMR), India

Export Dossiers – Global submissions that do not compromise proprietary information Peter M. Lassoff, Vice President and Head of Global Regulatory Affairs, Quintiles Inc., UK


STORYLINE DOCUMENTSSession Chair:Thomas Martin Schindler, Head Medical Writing, Boehringer Ingelheim Pharma GmbH & Co.KG, Germany

Key objectives of regulatory documents are the presentation of data and the description of the clinical development process and the targeted indication. Thus the preparation of these documents combines descriptive, expository writing (data presentation) and the design of a narration (the storyline). This session introduces the concept of storyline documents for the use in interactions with regulatory authorities.

The Storyline – A new document format for pre-submission meetings with regulatory authoritiesThomas Martin Schindler, Head Medical Writing, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany

Cook-book Writing versus Narrative Writing in Regulatory DocumentsJames Visanji, Medical Writing Manager, Trilogy Writing & Consulting GmbH, Germany

Creating a Storyline in Briefing Packages and Presentations for Scientific Advice MeetingsSusan Bhatti, Executive Director, European Regulatory Affairs and Medical Writing Premier Research, Germany


SUBMISSION CHALLENGESSession Chair: Nancy Tam, Director, Global Medical Writing, Biogen Idec, USA

Marketing applications have become increasingly complex as pharmaceutical and biotechnology companies embark on more extensive clinical development programmes and/or seek marketing approval in a growing number of countries. This evolving landscape has led to more information to present in marketing applications, more regional requirements to satisfy, and more questions from regulatory authorities to answer. This session will present strategies for meeting these submission challenges.

Keeping Your CSRs Global in the Face of Regional RequirementsHelena Ryer, Senior Director, Global Medical Writing & Translation, Sanofi Pasteur, USA

Mastering Data from Multiple Indications in Marketing ApplicationsNancy Tam, Director, Global Medical Writing, Biogen Idec, USA

Managing the Medical Writing Process for Responding to eCTD Questions in the EUDouglas Fiebig, Senior Partner, Trilogy Writing & Consulting GmbH, Germany


SUCCESSFUL REVIEWSSession Chair:Carolyn Whiston, Associate Director, Medical Writing Operations, Biogen Idec, USA

What can be done to ensure successful document reviews, and thus successful and high-quality documents? This session presents the components necessary for successful reviews, from the perspectives of the internal writer, the contractor, and stakeholders involved with providing their feedback through the review process. Firstly identifying issues, assumptions, and expectations as viewed by the author who is responsible for developing content and driving the document through to completion, the session will then discuss issues and considerations specific to bringing contractors into the mix. Finally, we will look at what reviewers themselves have had to say about their role in document development – what works, what doesn’t, and what makes sense for the future.

Building Efficiency in Document Reviews: Successful solutions and lessons learnedCarolyn Whiston, Associate Director, Medical Writing Operations, Biogen Idec, USA

Efficient Document Review: The contractor perspectiveVirginia Watson, Company Director, Clinical and Regulatory Writing Consultant, Dulcamara Ltd, UK

Understanding and Managing StakeholdersNoëlle Holten Pind, Principal Scientist, Novo Nordisk A/S, Denmark


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Dia mEmBErSHiPJoin DIA now to benefit from all the opportunities membership offers, and

network with colleagues who share your professional interests!

DIA members and volunteers gather for a pre-conference drink on the evening before the conference, on Monday, 7 October 2013 from 18:30 at The Doheny & Nesbitt, where Breffni Martin will host a relaxed welcome get-together and share local insights to Dublin (www.dohenyandnesbitts.ie).

Visit the DIA Booth in the Liffey Exhibition Hall for information on future events and opportunities and latest news about membership advantages.

“reaching around the World to Create a Global Community”DIA is an independent, global association of members from all stakeholder groups of the medicines development process. DIA provides a neutral forum for likeminded professionals and groups to share knowledge and discuss current challenges being experienced in their respective fields of work. Join DIA now to advance your professional life and be part of the global community.

Your DIA membership provides you with exclusive access to:

NETWORKING & COMMUNITIESAs a DIA member you are free to join any of the 30+ professional DIA Communities (formerly SIACs). Join now to hold the momentum of the Clinical Forum and stay in contact with the people you meet in Dublin. As a Community member you will have access to ConneX, a secure online collaborative network. It provides tools to share documents, events, and discussions with the click of a mouse. It is an access point to global networks that exchange information, and share professional knowledge and best practices. Network with regulatory, academic and industry professionals, as well as patient representatives from around the world!

PROFESSIONAL DEVELOPMENTTake advantage of special members-only registration discounts on DIA’s expansive portfolio of conferences, training courses and other educational offerings, stretching across our curricula areas of CMC/Quality, Clinical Research, Regulatory Affairs, Safety and Pharmacovigilance, Non-Clinical Safety, and Eudravigilance. The early-bird registration fee offers industry members a €200 discount to DIA meetings on early registrations.

The searchable Career Centre with employment opportunities, allows you to sort by region, interest area, job type or keyword, and then submit your résumé, all confidentially and online.

MEMBERS ONLY NEWS & PUBLICATIONSDIA DailyA daily e-newsletter summary of breaking news from the pharma, biotech and medical device fields

Therapeutic Innovation & Regulatory Science (TIRS)The TIRS Journal is a bi-monthly peer-reviewed scientific journal covering innovation in drugs, medical devices, diagnostics, and regulatory science. It can be delivered online, or in print. It replaced the DIJ (Drug Information Journal) in January 2013.

Global ForumThe Global Forum is a bi-monthly digital magazine that provides global coverage of industry topics and product innovation as well as the latest member news and what is going on in the association. Don’t miss the November 2013 issue which will include an article on the Clinical Forum and summarise the take-aways of this years meeting.

Become a member noW! Visit the Dia Booth in the Exhibition Hall to find out more

about Dia membership and Communities. or go to diahome.org/membership for

more details, to become a member and start enjoying the advantages now!

Take the first step in Dublin!

Scan to join!

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netWorKing oPPortunitieSFrom a kick-off drink in one of the most traditional Dublin pubs to interactive working lunches, evening receptions and coffee breaks, the Clinical Forum’s schedule of networking opportunities offers something for everyone. Build business relationships and expand professional contacts at social events while enjoying excellent local food and drinks.

Gain new perspectives, exchange ideas and generate new clients from one-on-one discussions with speakers, exhibitors and fellow delegates from various industry sectors and over 20 countries. Explore the latest technologies on the exhibition floor and connect with colleagues from the industry, government and academia.

WHo You Will meetThe Clinical Forum is the platform for pharmaceutical and biotech industry professionals, medical information professionals, academia, CROs, clinical trial sites, health regulatory agencies and delegates from patient organisations.

Areas of interest include:• eClinical / Clinical data management• Clinical operations, clinical research• Clinical safety, pharmacovigilance and risk management• Medical affairs• Epidemiology• Medical information, medical communications• Medical writing• Quality assurance• Patients• Project management• Business and IT computer system validation

n E T W o r K i n GDuBlin 2013

Your regiStration inCluDeS an extenDeD netWorKing reCePtion on tueSDaY anD more!

Unofficial Kick-off Gathering at the Doheny & NesbittBreffni Martin welcomes you to Dublin and shares local insights Monday, 7 October 2013 from 18:305 Baggot Street LowerDublin 2, Co. [email protected]+353 1 6762945

Fellowship Networking ReceptionStudents and Young Professionals who attend the pre-conference session at Hotel Clarion ISFC on Monday, 7 October are invited to a Networking Reception for a drink from 17:00 – 18:00.

Networking ReceptionThe Networking Reception will take place in the Liffey Exhibition Hall Tuesday, 8 October 2013 from 17:30 – 19:30

The reception is open to all delegates. Enjoy wine, beer, soft drinks and food with local flavours.

Network on the Exhibition FloorAll refreshments will be served in the Liffey Exhibition Hall making it the ideal place to meet the people you want to meet. A designated Networking Zone will make it easy for fellows to meet with stakeholders, students, young professionals, and other fellows. Make this your meeting point during the conference to connect.

DIA BoothThe DIA Booth in the Liffey Exhibition Hall is the centre for all information about the Clinical Forum and other DIA offerings, networking opportunities, DIA membership benefits and volunteer opportunities. Come by and say hello to us, you may be happily surprised!

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E X H i B i T i o nDuBlin 2013

Exhibiting Companies as of 13 September 2013Company Country Booth N°

AMEDON GmbH Germany 18B

ArisGlobal Ltd Ireland 19B & 21B

Carrot Pharma Recruitment United Kingdom 35MB

CCRA United Kingdom 36MB

CPRD United Kingdom 1B

CRF Health United States 27B

CTC Clinical Trial Consulting Switzerland 17B

DATATRAK United States 26B

DIA Switzerland 12B

Dianthus Medical Limited United Kingdom 5B

Entimo Germany 22B

ERT United States 2B

Eurofins Optimed France 34MB

GP Strategies United States 6B

Java Clinical Research Ltd Ireland 31MB

Company Country Booth N°

Larrey Ltd Lituania 30MB

MakroCare United Kingdom 28MB

OmniComm Systems, Inc. Spain 32MB

Online Business Applications United States 16B

Perceptive Informatics United States 15B

PHT Switzerland 3B

PPD United States 29MB

PrimeVigilance Limited United Kingdom 13B

ProClinical Limited United Kingdom 11B

Real Regulatory Limited Ireland 20B

Sciformix United States 14B

the Uppsala Monitoring Centre Sweden 10B

Veeva Systems United Kingdom 4B

World Courier United Kingdom 33MB

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THanK You To our CliniCal Forum 2013 rECEPTion HoST!

Thank you to World Courier for hosting the Tuesday

Networking Reception.

ViSiT WorlD CouriEr aT BooTH 33mB

EXHiBiTorSJoin uS aT THE EuromEETinG 2014 EXHiBiTion !Connect with pharmaceutical, medical device and related companies as they showcase the hottest products that foster innovation to improve health and well-being worldwide.

WHY exHiBit at tHe euromeeting?The Annual EuroMeeting brings together

more than 3,000 biopharmaceutical,

contract service organisation, academic

research centre, and regulatory affairs

professionals from more than 50 countries,

making it Europe’s largest and most

respected industry event of its kind. DIA

Europe’s annual flagship event offers timely

and relevant session topics, continuing

education, networking opportunities, and

access to one of the largest exhibition

floors in Europe.

HigHligHtS From tHe euromeeting exHiBition Anticipated EuroMeeting attendance of

more than 3,000

Join more than 170 exhibitors to connect with attendees from more than 50 countries

Explore the latest technologies and services, all under one roof

For more information on exhibition space,

hosting opportunities, prices

and facilities, please contact

Roxann Schumacher at

+41 61 225 51 38 or email:

[email protected]

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Exhibitor Services (Description provided by Exhibitor)

AMEDON GmbH Booth 18BAMEDON provides individual EDC-Solutions adapted to the requirements of the study design. Together with our partner PharmaForms we are developing hybrid solution by using dotforms® technology and the digital pen. “Adapt the system to the needs of the study and the user and optimize acceptance to get better data quality!

ArisGlobal Booth 19B and 21BArisGlobal is the leading provider of integrated solutions for pharmacovigilance & safety, regulatory affairs, clinical research, and quality & compliance for medical inquiries. Life science companies using our solutions can better build and maintain the trust they need with their customers, medical practitioners and global regulatory bodies.

Carrot Pharma Recruitment Booth 35MBSince 2006, when it was set up by two ex-pharma industry professionals, Carrot Pharma Recruitment has become one of the most respected recruitment partners to a huge range of pharmaceutical clients (in-house and consultancy) across the UK, Europe and beyond.We have an excellent track record of finding and securing the best talent in these areas both for contract and permanent roles. Come and meet us on stand 35.

CCRA (Clinical Contract Research Association) Booth 36MBIf you are serious about the conduct of clinical trials to the highest standards and take any part in the industry (CRO or service provider in this sector) come and talk to us about membership! CCRA is the UK trade association which represents this sector and provides enhanced business opportunities, a badge of quality and a voice for the industry.

CPRD Booth 1BCPRD delivers major efficiencies to the clinical trials process via new digital platforms that enable fast access to large national data sets. Services include near real time feasibility, protocol optimisation and patient and site recruitment. Visit us to find out how a National Healthcare System approach can deliver a step change in clinical research.

CRF Health Booth 27BCRF Health is a global leader in eCOA (electronic Clinical Outcome Assessments) solutions for the life sciences industry. eCOA encompasses PROs (Patient Reported Outcomes), ObsROs (Observer Reported Outcomes) and Clin£R£Os (Clinician or Rater Reported Outcomes) with outstanding project management focused on delivering value for our customers.

CTC Clinical Trial Consulting AG Booth 17BCTC Clinical Trial Consulting provides flexible resourcing solutions to the Pharmaceutical and Biotech industry. We provide high calibre professional staff to fill both contract and permanent positions in all areas of Drug Development. We provide various other services such as clinical trial management, monitoring, medical writing and training courses as well as payrolling, contract management and HR management.

DATATRAK Booth 26BDATATRAK is the leader of unified eClinical® technologies and related services for clinical trials. Using the DATATRAK ONE™ cloud-based clinical research platform, DATATRAK’s Clinical and Consulting Services group assists clients in conducting Phase I-IV drug and device studies in multiple languages throughout the world. www.datatrak.com

Dianthus Medical Limited Booth 5BDianthus Medical is an innovative company providing medical writing and analytical solutions for the pharmaceutical industry and other organisations working in the biomedical sector.Dianthus Medical is an innovative company providing medical writing and analytical solutions for the pharmaceutical industry and other organisations working in the biomedical sector.

Entimo AG Booth 22BEntimo provides superior quality IT products, custom solutions and reliable services which streamline the clinical development processes.entimICE® Integrated Clinical Environment provides: Data and metadata repository, Standards management, Data transformation to SDTM, ADaM and other models, Statistical computing environment, Data consistency checks, Define.xml generation

ERT Booth 2BERT is a leading provider of high-quality patient safety and efficacy endpoint data collection solutions for use in clinical drug development. ERT delivers a combination of technology, services, and consulting that increase the accuracy and reliability of patient data and improve the efficiency of the clinical development process throughout the product lifecycle.

Eurofins Optimed Booth 34MBSince 1990, Eurofins OPTIMED has been providing services in clinical research and biometry, from phase I to phase II-IV clinical trials and clinical studies in Nutrition and Medical Devices. With the experience of more than 800 clinical studies, Eurofins Optimed is a reliable partner for pharmaceutical and biotechnology companies and the agro-food industry.

GP Strategies Booth 6BYour work creates an impact on your company and the world around you. GP Strategies is a global performance improvement company driven to solve your organization’s business challenges; perform at the highest level; and make a greater impact through the strategic use of knowledge, training and consulting.

Java Clinical Research Ltd Booth 31MBJava Clinical Research Ltd is a Contract Research Organisation providing Clinical Trial Management and Drug Development Consultancy Services to the pharmaceutical, biotechnology and medical device industries. The company is led by research professionals with extensive experience in in a wide range of therapeutic areas from single centre intensive studies, to international multicentre trials.

Larrey Ltd Booth 30MBLarrey CRO provides clinical research services in Lithuania, Latvia, Estonia and Ukraine. Larrey combines good knowledge of local market and high international standards of the industry. Larrey provides high-quality, professional and flexible services to meet our client needs. Please visit our web page www.larrey.eu for more information.

MakroCare Booth 28MBMakroCare established in 1996 with USA as HQ is a global Development and Commercialization firm. MakroCare has 5 subsidiaries (Regulatory, CRO, SMO, Informatics and Commz) that support various aspects of Product Life Cycle. MakroCare leverages teams positioned in USA, UK, Europe, India, China, Singapore and Japan to optimize productivity and costs.

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OmniComm Systems, Inc. Booth 32MBOmniComm is dedicated to helping pharmaceutical, biotechnology, CROs, research & medical device organizations maximize the value of their clinical research investments through the use of innovative and progressive technologies. Our Electronic Data Capture (EDC) and eClinical technologies have been used in over 3800 clinical trials around the globe.

Online Business Applications Booth 16BFor over twenty five years, Online Business Applications has been committed to providing advanced software solutions for the Pharmaceutical, Biotechnology, and Medical Device industries in the areas of Medical Communications and Drug Safety. We utilize proven leading-edge technologies, anticipate our clients’ needs, and deliver solutions that exceed expectations, making us the medical communications software provider of choice.

Perceptive InformaticsPerceptive Informatics Booth 15BPerceptive Informatics, subsidiary of PAREXEL, provides leading eClinical solutions, helping to accelerate the clinical development process through technology innovation. Perceptive’s fully-integrated eClinical suite including EDC, RTSM, CTMS, ePRO, Medical Imaging and more, can now be delivered through a single place - Perceptive MyTrials.

PHT Corporation Sàrl Booth 3BPHT Corp helps pharmaceutical companies conduct trials with greater confidence, ease and accuracy. Proven PHT eCOA Systems collect patient-driven eData via smartphones, tablets and the web. PHT has helped trial sponsors in 600+ global trials resulting in 16 regulatory approvals. Visit phtcorp.com for more information. Follow PHT on LinkedIn, Twitter and YouTube.

PPD Booth 29MBPPD is a leading global contract research organization providing drug discovery, development and lifecycle management services. PPD offers a suite of medical communications services to support clinical trial needs. Our expert team is the partner of choice for applying quality medical communications to maximize a product’s success. www.ppdi.com.

ProClinical Limited Booth 11BEstablished in 2005, ProClinical is a top tier staffing provider that has placed over 1000 industry professionals throughout Europe. We work to source the strongest talent across the drug development life cycle for our clients, that include leading pharmaceutical, biotechnology, medical device and clinical research organisations.

Real Regulatory Ltd Booth 20BReal Regulatory is an independent consultancy and outsourcing firm which specialises in Regulatory Affairs in the pharmaceutical, medical device and related industries. Our highly experienced team of consultants can provide immediate hands-on assistance with clinical development, registration and lifecycle management.

Sciformix Booth 14BSciformix Corporation is a global scientific process organization (SPO) that partners with life science companies to develop, launch and sustain medical products that aim to improve the quality of healthcare worldwide. We collaborate with our clients through the entire product development lifecycle to provide a full range of services from study design to post marketing surveillance and commercialization support.

The Uppsala Monitoring Centre Booth 10BThe Uppsala Monitoring Centre (UMC) offers tools & resources to enhance Clinical Trials & Drug Safety Operations. UMC is the maintenance organization for the WHO Drug Dictionary Enhanced and WHO Herbal Dictionary, used globally for coding and analyses of concomitant medication data.

Veeva Systems Booth 4BVeeva Systems is a leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence and customer success, Veeva has over 150 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs. Founded in 2007, Veeva is headquartered in the US with offices worldwide.

World Courier Ireland Ltd Booth 33MBWorld Courier is the leader in specialty logistics for global clinical trials delivering fully-integrated GxP-compliant temperature-controlled transport, storage and distribution solutions worldwide in over 10.000 clinical studies . World Courier has a network of over 150 company offices operating in more than 50 countries.

Exhibitor Services (Description provided by Exhibitor)

Joint DIA/IMB CESP Information Day

20 November 2013 Hotel DoubleTree by Hilton Dublin (formerly The Burlington Hotel)Dublin, Ireland ID #13111

27

ATMP Advanced Therapy Medicinal Products

CCD The Convention Centre Dublin

CDISC Clinical Data Interchange Standards Consortium

CDM Clinical Data Management

CEO Chief Executive Officer

CMC Chemistry, Manufacturing and Control

CPD Commission for Professional Development

CRA Clinical Research Associate

CRF Case Report Form

CRO Contract Research Organisation

CSR Clinical study report

CTID Clinical Trial Information Disclosure

CTOM Clinical Trial Operation Manager

CTTI The Clinical Trials Transformation Initiative

DIA Drug Information Association

DSUR Development Safety Update Report

ECCRO Emerging Country Contract Research Organisation

eCRF Electronic Case Report Form

eCTD Electronic Clinical Trial Dossier

EDC Electronic Data Capture

EDM Electronic Document Management

EFPIA European Federation of Pharmaceutical Industries and

Associations

EHR Electronic Health Record

EMA European Medicines Agency

EMEA Europe, the Middle-East and Africa

ENCePP European Network of Centres for Pharmacoepidemiology and

Pharmacovigilance

ePRO Electronic Patient Reported Outcome

EPSA European Pharmaceutical Students‘ Association

eTMF Electronic Trial Master File

EU European Union

EudraCT is a database of all clinical trials commencing in the Community

from 1 May 2004 onwards. It has been established in accordance

with Directive 2001/20/EC. https://eudract.ema.europa.eu/

EUPATI European Patients’ Academy on Therapeutic Innovation

FDA Food and Drug Administration

FPM Faculty of Pharmaceutical Medicine

GCP Good Clinical Practice

GLP Good Laboratory Practice

GMI Global Medical Information

GxP Good Practice

HCP Health Care Provider

HCV Hepatitis C Virus

HEOR Health economics and outcomes research

HTA Health Technology Assessment

ICH International Conference on Harmonisation

IFSC International Financial Services Centre

IMB Irish Medicines Board

IT Information Technology

LLC Limited Liability Company

MAA Marketing Authorisation Application

MHRA Medicines and Healthcare products Regulatory Agency

MI Medical Information

NCA National Competent Authority

NCE New Chemical Entity

NIS Non Interventional Studies

OECD Organisation for Economic Cooperation and Development

PC Personal Computer

PRO Patient Reported Outcome

PSUR Periodic Safety Update Report

PV Pharmacovigilance

QA Quality Assurance

QbD Quality by Design

QPPV Qualified Person for Pharmacovigilance

QR Quick Response (QR) Code

RBM Risk-Based Monitoring

R&D Research and Development

REMS Risk Evaluation and Mitigation Strategy

RCP Royal College of Physicians

RMM Risk Minimisation Measures

RMP Risk Management Plan

RTSM Randomisation and trial supply management

S.A. Public, (as opposed to private) limited company

SaaS Software as a Service

SGPM Swiss Society of Pharmaceutical Medicine

SIAC Special Interest Area Community

SOP Standard Operating Procedure

SwAPP Swiss Association of Pharmaceutical Professionals

TIRS Therapeutic Innovation & Regulatory Science

VP Vice President

CliniCal Forum 2013 gloSSarY oF termS

EuromEEtingVi E n n A 2014

2 6 t h A n n u A l

25-27 March 2014ACV, Vienna, Austria

regiStration Form7th Annual Clinical Forum 8-9 October 2013 | The Convention Centre Dublin, Ireland iD #13103

ATTENDEE DETAILS Please complete in block capital letters or attach the attendee’s business card here.

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The DIA Europe Customer Services Team will be pleased to assist you with your registration from Monday to Friday between 08:00 and 17:00 CET. © DIA 2013Email [email protected] Tel. +41 61 225 51 51 Fax +41 61 225 51 52 Web www.diaeurope.org Mail DIA Europe, Kuechengasse 16, 4051 Basel, Switzerland

Cancellation Policy

All cancellations must be made in writing and be received at the DIA Europe office five working days prior to the event start date. Cancellations are subject to an administrative fee:• Industry (Member/Non-member) € 200.00 • Academia/Charitable/Government/Non-profit (Full-time) (Member/Non-member) € 100.00 • Workshop cancellation € 50.00

If you do not cancel five working days prior to the event start date and do not attend, you will be responsible for the full registration fee. DIA Europe reserves the right to alter the venue and dates if necessary. If an event is cancelled or postponed, DIA Europe is not responsible for airfare, hotel or other costs incurred by registered attendees. Registered attendees are responsible for cancelling their own hotel and travel reservations.

Transfer PolicyYou may transfer your registration to a colleague prior to the start of the event but membership is not transferable. Substitute attendees will be responsible for the non-member fee, if

applicable. Please notify the DIA Europe office of any such substitutions as soon as possible.

Photography PolicyBy attending the event, you give permission for images of you, captured during the conference through video, photo, and/or digital camera, to be used by DIA Europe in promotional materials, publications, and website and waive any and all rights including but not limited to compensation or ownership.

Early-bird rates available for members: Register by Tuesday, 27 August 2013Join DIA now to qualify for the Early-bird member fee! The Early-bird registration form and accompanying payment must be received by the date above. Early-bird fee applies to industry members only. (www.diahome.org/membership) € 1’165.00

FEES (after 27 August 2013) Member* Non-Member*

Industry € 1’365.00 € 1’480.00

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Join DIA now to qualify for the member rate € 115.00

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If DIA cannot verify your membership upon receipt of registration form, you will be charged the non-member fee.

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Registration fee includes: refreshments, lunches and meeting material.

Payment is due 30 days after registration and must be paid in full by commencement of the event.

PRE-CONFERENCE WORKSHOPS (7 OCTOBER 2013)

I wish to attend:

Workshop 1 - The Clinical Trial Transformation Initiative € 250.00

Workshop 2 - Electronic Archives are Not your system backup media € 250.00