global labeling 2012: impact on risk management & other ......sanofi united states this session...

PROGRAM COMMITTEE

Steven W. Bass, PhDPresidentBass Biopharm Consulting Group LLC

Bruce Boulton, MScProduct Information OfficerBureau of Gastroenterology, Infection and Viral DiseasesTherapeutic Products Directorate, Health Canada

Mark A. Collins, PhD, MBADirector, Pharmacovigilance and Risk ManagementEndo Pharmaceuticals Inc.

Barbara J. Fanelli, MScAssociate Vice President, Global Regulatory Affairs LabelingSanofi

Dr. med. A. Leander FontainePresidentPharmiceutics, LLC

Johannes Kneer, PhDSenior Director, Global Head of Regulatory LabelingF. Hoffmann - La Roche LTD

Su-Yueh Lin, RPh, MSDirector, Regulatory LabelingRegereron Pharmaceuticals Inc

Rie Matsui, R. Ph Director, Regional Labeling Head for AsiaMedical Documentation, Labeling and SubmissionManagement Worldwide Safety & RegulatoryPfizer Japan Inc.

Gerrit-Jan Nijveldt, MScSenior Director, Global Regulatory Affairs LabelingSanofi

Barbara Lachmann, MDSenior AdvisorCenter of Excellence Product InformationMerck KGaA

Junko Sato, PhDInternational Liaison OfficerPharmaceuticals and Medical Devices Agency (PMDA)Japan

This program has been developed by the Regulatory Affairs SIAC-Labeling Working Group

DIA Worldwide Headquarters800 Enterprise Road, Suite 200

Horsham, PA 19044, USADIA Regional Offices

Horsham, PA, USA | Washington, DC, USABasel, Switzerland Tokyo, Japan Mumbai, India Beijing, China

Global Labeling 2012: Impact on Risk Management & Other Global and Regional Initiatives

October 11-12Silver Spring Civic Building, Silver Spring, MD

MEETING HIGHLIGHTS• Evolvingbestpracticesforriskmanagementandlabeling• Understandinglabelingasanessentialcommunicationtool• Europelabelingrulesandchallenges• HottopicsinCanada,Europe,Japan,andUnitedStates• Networkingopportunities• Exhibithall

What future impactwill the new riskmanagementguidelines/guidances andotherinitiativeshaveforcorelabelinginthefuture?Getanswerstothisquestionandmoreinthistwo-dayconference.During the first day the emphasis will be on the role of labeling in riskmanagement.Expertswilldiscussthecurrentroleoflabelingandwhatimpactnewguidelines/guidancesandothernewriskmanagementinitiativeswillhaveon the labeling components in the future, aswell as howeffective all of thecurrentlabelingcomponentsareincommunicatingtoprescribersandpatientsand/orinfluencingtheprescribingbehavior.

In day two, the focuswill be on the basics of global labeling aswell as anylabelinghottopicsonagloballevelwithemphasisonrecentproposedornewinitiativesintheUnitedStates,Europe,Canada,andJapan.

LEARNING OBjECTIvESAttheconclusionofthisconference,participantsshouldbeableto:• Describehowlabelingisacornerstoneofagoodrisk

managementplan• Explainpotentialimpactofnewriskmanagementguidelineson

corelabeling• Discussbasicprescriptiondruglabelingandnewglobalhottopics

WHO SHOULD ATTENDProfessionalsinvolvedin:• ClinicalSafety/

Pharmacovigilance• Labeling• RegulatoryAffairs• AdvertisingandPromotion• ClinicalResearch

• MedicalWriting• MedicalCommunications• ProductResearchandDevelopment• QualityAssurance/QualityControl• PublicPolicy/Law/Corp.

Compliance

2

continuing education

The Drug Information Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This program is designated for 3 contact hours or .3 continuing education units (CEU’s).

Drug Information Association has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET), 1760 Old Meadow Road, Suite 500, McLean, VA 22102.

As an IACET Authorized Provider, Drug Information Association offers CEUs for its programs that qualify under the ANSI/IACET Standard. Drug Information Association is authorized by IACET to offer 1.4 CEUs for this program. Participants must attend the entire program in order to be able to receive an IACET statement of credit. No partial credit will be awarded.

This meeting is part of DIA’s Certificate Program and is awarded the following:

• Regulatory Affairs Certificate Program: 8 Elective Units

For more information go to www.diahome.org/certificateprograms

If you would like to receive a statement of credit, you must attend the program, sign-in at the DIA registration desk each day of the program, and complete the on-line credit request process through My Transcript at www.diahome.org. Participants will be able to download a statement of credit upon successful submission of the credit request. My Transcript will be available for credit requests on October 26, 2012.

Disclosure Policy It is Drug Information Association policy that anyone in a position to control the content of a continuing education activity must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and/or the educational activity, and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Faculty disclosures will be included in the course materials.

continuing education PHaRMacY cRedit aLLocationSession 4: Effectiveness of Labeling Components Part 1: Pharmacy 1.5 contact hours or 1.5 CEUs; UAN: 286-000-12-089-L04-P; Type of Activity: Knowledge

Session 9: Global Labeling Hot Topics US: Pharmacy 1.5 contact hours or .15 CEUs; UAN: 286-000-12-090-L04-P; Type of Activity: Knowledge

Unlessotherwisedisclosed,thestatementsmadebyspeakersrepresenttheirownopinionsandnotnecessarilythoseoftheorganizationtheyrepresent,orthatoftheDrugInformationAssociation.

Speakers,agenda,andCEinformationaresubjecttochangewithoutnotice.

RecordingofanyDIAeducationalmaterialinanytypeofmedia,isprohibited

withoutpriorwrittenconsentfromDIA.

ToviewDIA’sGrievancePolicy,pleasevisittheCEpageonDIA’swebsiteatwww.diahome.org.

Travel Once, Learn Twice!Held back-to-back with:

Principles and Practical Approaches to Global Risk Managementoctober 9-10

Silver Spring Civic Building, Silver Spring, MD

3

WednesdAy, OctObeR 10

6:00-8:00 pm RegistRation

thuRsdAy, OctObeR 11

7:15-8:00 am RegistRation and continentaL BReaKFast

8:00-8:15 am WeLcoMe and oPening ReMaRKs

Steven W. Bass, PhDPresidentBass Biopharm Consulting Group LLCUnited States

8:15-9:00 am session 1

introduction: Risk-Management-Related aspects of global (core) and Local Labeling

SeSSion PreSenter

Barbara Fanelli, MScAssociate Vice President, Global Regulatory Affairs Labeling SanofiUnited States

Thissessionwillbeanintroductiontotheroleofbothcorporate(core)and local labeling worldwide, providing information about the risk-benefitbalanceoftheproductandhowtheexpectationsexpressedindraftlabelingguidelinesmayimpacttheseroles.

9:00-10:30 am session 2

Labeling and Risk Management – How Labeling documents are used for Risk Management SeSSion ChairPerSon

Mark A. Collins, PhD, MBADirector, Pharmacovigilance and Risk ManagementEndo Pharmaceuticals Inc.United States

In this session regulators from theUS,EU,CanadaandJapanwill discusshowlabelingisusedastheprimaryriskmanagementtoolintheircountry/region.

SeSSion PreSenterS

Labeling as a Risk Management tool in canadaBruce Boulton, MScProduct Information OfficerBureau of Gastroenterology, Infection and Viral DiseasesTherapeutic Products Directorate, Health CanadaCanada

Labeling as a Risk Management tool in the usAnn Marie Trentacosti, MDMedical Lead, Study Endpoints and Labeling DevelopmentOffice of New DrugsCDER, FDA, United States

Labeling as a Risk Management tool in JapanShoko Sekine, MSReviewerPMDAJapan

Labeling as a Risk Management tool in europeDaniel Becker, MD, PhD, EDPMScientific AdministratorEuropean Medicines Agency (EMA)(Participating via Live Webinar)

10:30-11:00 am REFRESHmENT BREaK

11:00 am–12:00 pm session 3

impact of icH e2c (R2) and eu gVP guidelines on core Labeling PracticesSeSSion ChairPerSon

Dr. med. Leander FontainePresidentPharmiceutics LLCUnited States

ThissessionwillanalyzethepotentialimpactofICHE2C(R2)andEUGVPGuide-linesontheinformationtobeincludedinCompanyCoreDataSheetsandontheintensityofCorelabelingimplementationtracking.

SeSSion PreSenter

Dr. med. Leander FontainePresidentPharmiceutics LLCUnited States

PaneliStS

Julie P. Retzinger, RN, MBADirector, Global Regulatory AffairsBaxter Healthcare CorporationUnited States

Barbara Lachmann, MDSenior AdvisorCenter of Excellence Product InformationMerck KGaAGermany

Barbara Fanelli, MScAssociate Vice PresidentSanofiUnited States

Bruce Boulton, MScProduct Information OfficerBureau of Gastroenterology, Infection and Viral DiseasesTherapeutic Products Directorate, Health CanadaCanada

Shoko Sekine, MSReviewerPMDAJapan

4

12:00-1:00 pm LUNCHEON

1:00-2:30 pm session 4

effectiveness of Labeling components Part 1SeSSion ChairPerSon

Gerrit-Jan Nijveldt, MScSenior Director Global Regulatory Affairs Labeling SanofiUnited States

Thissessionwilldiscusstheeffectivenessoflabelingandlabelingrelatedcompo-nentsincommunicatingissuestoprescribersandpatients.Itwillalsohaveare-centexampleonlabelinginREMS/RMP.Thefollowingquestionswillbediscussed:Islabelinganeffectivecommunicationtool,yesorno?Doesitinfluencechangesinprescribers’practices?Whatmightbethebestwaytoprovidethedoctorandpharmacistwiththemostuptodateinformationtoprovidetopatients?

SeSSion PreSenterS

opioid ReMs from a Labeling Perspective Mark A. Collins, PhD, MBADirector, Pharmacovigilance and Risk ManagementEndo Pharmaceuticals Inc.United States

Labeling as an effective tool - “Labeling as a communication tool (in Risk Management) is effective” David Dickinson, MS Principal ConsultantConsumation, Ltd.United Kingdom

Labeling as an effective tool - “Labeling as a communication tool (in Risk Management) is not effective.” Edgar H. Adams, ScD Executive Director, Epidemiology Covance Market AccessUnited States

2:30-3:15 pm session 5

effectiveness of Labeling components Part 2SeSSion ChairPerSon

Gerrit-Jan Nijveldt, MScSenior Director Global Regulatory Affairs Labeling SanofiUnited States

Part2willbeapaneldiscussionbetweenindustryandregulatoryagencies.

PaneliStS

Mark A. Collins, PhD, MBADirector, Pharmacovigilance and Risk ManagementEndo Pharmaceuticals Inc.United States

Bruce Boulton, MScProduct Information OfficerBureau of Gastroenterology, Infection and Viral DiseasesTherapeutic Products Directorate, Health CanadaCanada

David Dickinson, MS Principal ConsultantConsumation Ltd.United Kingdom

Edgar H. Adams, ScD Executive Director, Epidemiology Covance Market AccessUnited States

Shoko Sekine, MSReviewerPMDAJapan

3:15-3:45 pm REFRESHmENT BREaK

3:45-5:30 pm session 6

eu Labeling Rules and challengesSeSSion PreSenter

Barbara Lachmann, MDSenior AdvisorCenter of Excellence Product InformationMerck KGaAGermany

ThissessionwillprovideaconciseoverviewonlabelingrulesintheEu-ropeanUnion.ItwilloutlinemajordifferencesincontentrequirementstoUS labeling.Furthermore, itwill explain specificchallengeswhichresultfromthemulti-nationalorganizationandmulti-lingualcultureoftheEuropeanUnion.

5:30-7:00 pm RECEpTION

5

FRidAy, OctObeR 12

7:30-8:00 am REGISTRaTION aND CONTINENTaL BREaKFaST

8:00-10:00 am session 7

eu Labeling Rules and challenges (continued from day 1 session 6)

SeSSion PreSenter

Barbara Lachmann, MDSenior AdvisorCenter of Excellence Product InformationMerck KGaAGermany

10:00-10:30 am REFRESHmENT BREaK

10:30-12:00 pm session 8

global Labeling Hot topics canadaSeSSion PreSenter

Bruce Boulton, MScProduct Information OfficerBureau of Gastroenterology, Infection and Viral DiseasesTherapeutic Products Directorate, Health CanadaCanada

ThissessionwillprovideanunderstandingoffourlabelingtopicsandconcernsinCanada:

1)Basicprescriptiondrug labeling–Thebasicprinciplesof labeling,theProductMonographGuidanceandcomponents,theprescribinginformation and the Consumer Information will be explained,especiallyusefultothenewemployee.

2)Thedraftguidance–LabelingofPharmaceuticalDrugsforHumanUse – experience two years after external posting, commentsreceivedandthechangesmadetothefinalguidance

3)Look-alike,sound-alike(LASA)brandnameassessmentguidance– experience and evolution in how this guidance has been used,the deficiencies in this guidance and the need for and currentdevelopmentofanexpandedguidance

4)PlainLanguagelabelinginitiative–anewdirection–proposalandhowthiswillchangedruglabelinginthefuture.

Also included in this presentation will be a 15-minute question andanswerperiod.

12:00-1:00 pm LUNCHEON

1:00-2:30 pm session 9

global Labeling Hot topics us SeSSion ChairPerSon

Steven W. Bass, PhDPresidentBass Biopharm Consulting Group LLCUnited States

Regulators from the United States will discuss “Hot” topics in Labeling in theUnitedStates.

InthissessiontheFDAwillfocusonpresentingtwotopics,patient-centeredcom-municationsandprescribinginformationupdate.Thepatient-centeredcommuni-cationspresentationwillexplainhowthisinitiativeisintendedtoprovidequalityprescriptionproduct informationtoaidpatients inusingtheirprescriptions inasafeandeffectivemanner.Attendeeswillbeabletodemonstrateageneralunder-standingofcurrentformsofpatientinformationandofapotentialfutureformofinformation,PatientMedicationInformation(PMI).

Theprescribing informationpresentationwill discuss newCDER labelingguid-ancesandinitiatives.Attendeeswilldevelopanunderstandingofhowthese la-belingguidancesandinitiativeswillultimatelyimprovetheoverallqualityoftheprescribinginformation.Alsoincludedinthissessionisa15minutequestionandanswerperiod.

SeSSion PreSenterS

Patient information updateBryon Pearsall, JD, RPhDivision DirectorDivision of Medical Policy Programs/OMPICDER, FDAUnited States

LaShawn Griffiths, MSHS-PH, BSN, RN Associate Director for Patient Labeling Division of Medical Policy Programs /OMPICDER, FDA, United States

Prescribing information update Ann Marie Trentacosti, MDMedical Lead, Study Endpoints and Labeling DevelopmentOffice of New Drugs,CDER, FDA, United States

2:30-3:00 pm ReFResHMent BReaK

3:00-4:00 pm session 10

6

global Labeling Hot topics JapanSeSSion ChairPerSon

Rie Matsui, R. Ph Director, Regional Labeling Head for AsiaMedical Documentation, Labeling and SubmissionManagement Worldwide Safety & RegulatoryPfizer Japan Inc.

ThissessionwillprovideanunderstandingofthreelabelingtopicsandconcernsinJapan:

1)Basicprescriptiondruglabeling–Thebasicprinciplesoflabeling,theJapanesePhysicianLabeling(PackageInsert)andcomponents,theprescribinginforma-tionwillbeexplained,especiallyusefultothenewemployee.

2)RegulatoryProcess forPhysician Labeling in Japan- The current and futureregulatoryprocessforlabelingwillbeexplainedanddiscussedbasedonthefinalrecommendationonPharmaceuticalAffairsLaw(PAL).

3)Dissemination on LabelingRevision: It is required to disseminate the safetylabelingrevisiontoHCPsinJapan.Howandwhatkindofinformationshouldbeprovidedwillbeexplained.

Alsoincludedinthispresentationwillbea15-minutequestionandanswerperiod.

SeSSion PreSenterS

Basic Labeling and global Labeling Hot topics in JapanShoko Sekine, MSReviewerPMDAJapan

Labeling Revision Process and Requirement for dissemination on safety Labeling Revision in Japan Rie Matsui, R. Ph Director, Regional Labeling Head for AsiaMedical Documentation, Labeling and SubmissionManagement Worldwide Safety & RegulatoryPfizer Japan Inc.

4:00-4:30 pm CLOSING REmaRKS

Gerrit-Jan Nijveldt, MScSenior Director Global Regulatory Affairs Labeling Sanofi, United States

Workshop Adjourned

Pharmacovigilance and Risk Management Strategies 2013

January 13-16 | Washington, DC

7

Travel Once, Learn Twice!Principles and Practical Approaches to Global Benefit-Risk ManagementOctober 9-10 | Silver Spring, MD

Global Labeling 2012: Impact on Risk Management & Other Global and Regional InitiativesOctober 11-12 | Silver Spring, MD

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Global Labeling 2012: impact on Risk Management & Other Global and Regional initiativesEvent #12022 • October 11-12Silver Spring Civic Building, 1 Veterans Place, Silver Spring, MD

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