global labeling 2012: impact on risk management & other ......sanofi united states this session...
TRANSCRIPT
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
TRAVEL AND HOTELTheDoubleTree byHiltonHotelWashingtonDC - Silver Spring is holding ablockofroomsatthereducedratebelowuntilSeptember17,2012,fortheDIAeventattendees.Roomavailabilityatthisrateisguaranteedonlyuntilthisdateoruntiltheblockisfilled.
single $169 double $169
Attendees must make their own hotel reservations. Contact the Double-Tree by Hilton Hotel by telephone at 1.800.222.Tree OR +1.301.589.5200and mention the DIA event. The hotel is located at 8727 Colesville Road,SilverSpring,Maryland,20910,USA.
cANcELLATiON POLicy: On or before OctObeR 4Administrative fee that will be withheld from refund amount:Member or nonmember = $200government or academia or nonprofit (Member or nonmember) = $100tutorial (if applicable) = $50
Cancellations must be in writing and be received by the cancellation dateabove.Registrantswhodonotcancelbythatdateanddonotattendwillberesponsibleforthefullregistrationfeepaid.Registrantsareresponsibleforcan-celling theirownhotel andairline reservations.Youmay transferyour regis-trationtoacolleagueatanytimebutmembershipisnottransferable.PleasenotifyDIAofanysuchsubstitutionsassoonaspossible.Substituteregistrantswillberesponsiblefornonmemberfee,ifapplicable.
diA reserves the right to alter the venue, if necessary. if an event is cancelled, diA is not responsible for any airfare, hotel or other costs incurred by registrants.
Participants with disabilities: Reasonable accommodations will be madeavailabletopersonswithdisabilitieswhoattendaneducationalactivity.ContacttheDIAofficeinwritingatleast15dayspriortoeventtoindicateyourneeds.
EVENT cONTAcT iNfORmATiONContact benjamin Zaitz, event Manager, Phone 1.215.293.5803 Fax +1.215.442.6199, email [email protected]
TAbLETOP ExHibiT iNfORmATiONAttendees may visit the tabletop exhibits during the event and receptions.Contact Jeff Korn, exhibits Associate, Phone +1.215.442.6184 Fax +1.215.442.6199, email [email protected]
REGiSTRATiON fORmRegister online or fax this page to +1.215.442.6199
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
Registration Fees IfDIAcannotverifyyourmembership,youwillbechargedthenonmemberfee.Registrationfeeincludesrefreshmentbreaks,luncheons,andreception(ifapplicable),andwillbeacceptedbymail,fax,oronline.
Registrations Fees for Global Labeling 2012:
Member Early-bird Opportunity on or before after seP. 20 seP. 20
Member Fee US $1340 q US $1490 q
Join dia now to qualify for the early-bird member fee! MeMBeRsHiPwww.diahome.org/Membership us $175 q
To qualify for the early-bird discount, registration form and accompanying payment must be received by the date above. Does not apply to government/academia/nonprofit members.
Nonmember Fee US $1,665 q
Discount Fees MeMBeR nonMeMBeR
Government(Full-time) US $595 q US $770 q
CharitableNonprofit/Academia(Full-time) US $745 q US $920 q
*If paying a nonmember fee, please check one box above, indicating whether you want membership.
Payment options: Register online at www.diahome.org or check payment method.
q cRedit cARdnumbermaybefaxedto:+1.215.442.6199.Youmayprefertopaybycheckorbanktransfersincenon-U.S.creditcardpaymentwillbesubjecttothecurrencyconversionrateatthetimeofthecharge.
q Visa q Mc q aMeX Exp Date______________________________
Card#___________________________________________________________________
Name(printed) ____________________________________________________________
Signature_________________________________________________________________
q checKdrawnonaUSbankpayable toandmailedalongwith this formto:Drug InformationAssociationInc,P.O.Box95000-1240,Philadelphia,PA19195-1240,USA.Pleaseincludeacopyofthisregistrationformtofacilitateidentificationofattendee.
q bAnK tRAnsFeRWhenDIAcompletesyourregistration,anemailwillbesenttotheaddressontheregistrationformwithinstructionsonhowtocompletetheBankTransfer.PaymentshouldbemadeinUSdollars.Yournameandcompany,aswellastheEventI.D.#mustbeincludedonthetransferdocumenttoensurepaymenttoyouraccount.
Bring Your Whole Team and Save!Register three individuals and receive a fourth registration
at no cost! all four individuals must register and prepay at the same time.
group registration is not available online or for already discounted event fees.
Please check the applicable category:
q Academia q Government q Industry q CSO q Student (Call for registration information)
LastName
FirstName M.I.
Degrees q Dr. q Mr. q Ms.
JobTitle
Company
Address (Asrequiredforpostaldeliverytoyourlocation) MailStop
City State Zip/Postal Country
email Required for confirmation
PhoneNumber FaxNumber Required for confirmation