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4PARALLEL tracks (Continued)1:30 pm-3:30 pmAPI: Role of EDQM in Globalization, Input onInspections and StandardsDr. Susanne KeitelDirector, European Directorate for the Quality of Medicines& Healthcare (EDQM), Council of Europe, FrancePanel Discussion: CMC Harmonization andRegulatory ChallengesChairDr. Georges FranceVice President, Global Quality Strategy and InternationalAffiliate Quality and Compliance (IAQC), Pfizer UK (ICHQ-IWG Member)PanelistsDr. Moheb NasrDirector, Office of New Drug Quality, Center for DrugEvaluation and Research (CDER), Food and Drug Administration (FDA), USA (ICH Q-IWG Member)Dr. Jacques MorénasAssistant Director, Inspectorate and Companies Department,The French Health Products Safety Agency (AFSSAPS), France(ICH Q-IWG Member, PIC/S)Dr. Lembit RägoCoordinator, Quality Assurance & Safety for Medicines (QSM),Essential Medicines Pharmaceutical Policies Department,World Health Organization (WHO), Switzerland (WHO ICH SCand GCG Observer)Dr. Susanne KeitelDirector, European Directorate for the Quality of Medicines &Healthcare (EDQM), Council of Europe, FranceDra. KustantinahHead, National Agency of Drug and Food Control (NA-DFC/BPOM), IndonesiaDr. Yukio HiyamaChief, Third Section, Division of Drugs, National Instituteof Health Sciences (NIHS), Ministry of Health, Labour andWelfare (MHLW), Japan (ICH Q-IWG Member)Track 3: Ethical Business Practices: Towards Better Marketing ComplianceSession ChairsDr. Megan KeaneyPrincipal Medical Adviser, Therapeutic Goods Administration (TGA), AustraliaMr. In-Bum KimSr. Director, Korean Research-based Pharmaceutical Industry Association (KRPIA), Republic of KoreaLatest Developments on Ethical Business Practices(EBP) in AustraliaUpdate on New RDPAC Code and LatestDevelopments in ChinaDr. Megan KeaneyMs. Jennifer ChenDirector, Legal Affairs, R&D-based PharmaceuticalAssociation Committee (RDPAC), P.R. ChinaPrincipal Medical Adviser, Therapeutic Goods Administration(TGA), AustraliaMs. Deborah MonkDirector, Innovation and Industry Policy,Medicines Australia, Australia3:30 pm–4:00 pmCode Compliance Governance in JapanMr. Yota KikuchiManager, Promotion Code & Public Affairs, sanofi-aventis,Japan (Vice Chair of Japan Pharmaceutical ManufacturersAssociation (JPMA) Promotion Code Working Committee)Refreshment Break4:00 pm–5:30 pm Plenary SessionSimilar Biotherapeutic Products (SBPs) in Asia: Opportunities and Challenges in Regulatory EvaluationSession ChairsDr. Sannie ChongActing Director, Generics and Biosimilars Branch, HealthSciences Authority (HSA), SingaporeDr. Fermin Ruiz de ErenchumLeader, Special Regulatory Task Force, Hoffmann-La Roche Ltd.,Switzerland (Chair of IFPMA Biotherapeutic Group)Do We Have a Common Understanding? Definitionsof SBPs and Key Principles in Evaluating SBPsDr. Peter RichardsonResponsible for Biological Quality of Medicines, HumanMedicines Development and Evaluation, EuropeanMedicines Agency (EMA), UKEvolving Regulatory Landscape for SBPs in AsiaDr. Fermin Ruiz de ErenchumLeader, Special Regulatory Task Force, Hoffmann-La RocheLtd., Switzerland (Chair of IFPMA Biotherapeutic Group)Chinese Taipei’s Perspectives of Regulationof Biosimilar MedicineMs. Joyce WangDivision of Drugs & New Biotechnology Products, Food andDrug Administration, Department of Health, Chinese Taipei(Session continued on next page)

5day 3 Thursday, April 288:30 am–10:00 am Plenary SessionElectronic Submissions and eCTD as Vehicle toReconcile Differences in Technical RegulatoryRequirementsSession ChairsMr. Gary M. GensingerDeputy Director, Office of Business Informatics, Center for DrugEvaluation and Research (CDER), Food and Drug Administration(FDA), USAMr. John W. KiserSenior Director, Global Pharmaceutical Regulatory Affairs,Submission Operations & Strategic Initiatives,Abbott Laboratories, USAThe Role of MedDRA in Pharmacovigilance ActivitiesDr. Patricia MozzicatoChief Medical Officer, MedDRA Maintenance & Support ServicesOrganization (MSSO), USA12:30 pm–1:30 pm Lunch BreakPlenary Session1:30 pm–3:00 pmGood Regulatory Practices, Including AssessmentReport, Efficient Use of Certificate of PharmaceuticalProduct (CPPs) and TransparencySession ChairsThe Advantages and Challenges of ElectronicRegulatory Submissions in eCTD and Non-eCTDElectronic Submissions (NeeS) Formats –An Industry PerspectiveDr. Megan KeaneyMr. John W. KiserSenior Director, Global Pharmaceutical Regulatory Affairs,Submission Operations & Strategic Initiatives, AbbottLaboratories, USADIA President ElectSenior Advisor, LEEM, France, (APEC HarmonizationCenter Advisory Board Member)Benefits to Implementing eCTD – A RegulatoryPerspectiveMr. Gary M. GensingerDeputy Director, Office of Business Informatics, Center forDrug Evaluation and Research (CDER), Food and DrugAdministration (FDA), USAPrincipal Medical Adviser, Therapeutic Goods Administration (TGA),AustraliaDr. Yves JuilletGood Regulatory Practices: Do We Have a CommonUnderstanding?Dr. Yoshiaki UyamaDirector, Division of Regulatory Research, Office of RegulatoryScience, Pharmaceuticals and Medical Devices Agency(PMDA), JapanPractical Use and Challenges Faced –An Asian Regulator PerspectiveOpportunities for Industry to Partner with DrugRegulatory Authorities (DRAs) to Further GoodRegulatory PracticesMs. Jalene PohRegulatory Consultant, Pharmaceuticals & Biologics Branch,Pre-Marketing Division, Health Products Regulation Group,Health Sciences Authority (HSA), SingaporeEfficient Use of CPPs10:00 am-10:30 amRefreshment Break10:30 am-12:30 pm Plenary SessionPharmacovigilance: How Do Regulatory Agenciesand Industry Work Together to Protect Patients?Session ChairsDr. Suzette Henares-LazoActing Director IV, Food and Drug Administration (FDA),PhilippinesDr. Paul EisenbergSenior Vice President, Global Regulatory Affairs and Safety,Amgen, USACurrent Status and New Directions forPharmacovigilance in KoreaDr. Joungwon OhDeputy Director, Pharmaceutical Safety Bureau, Korea Foodand Drug Administration (KFDA), Republic of KoreaIntegrating Risk Management into Global DrugDevelopment – Opportunities and ChallengesDr. Paul EisenbergSenior Vice President, Global Regulatory Affairs and Safety,Amgen, USAPost-Marketed Surveillance – A Shared ResponsibilityDr. Rebecca WangHead of Drug Safety Operation, Regional Center for AsiaPacific, Roche, P.R. ChinaDr. Romi SinghExecutive Director, Global Regulatory Affairs & Safety,Amgen, USADr. Lembit RägoCoordinator, Quality Assurance & Safety for Medicines (QSM),Essential Medicines Pharmaceutical Policies Department, WorldHealth Organization (WHO), Switzerland (WHO ICH SC andGCG Observer)3:00 pm-3:10 pm Closing Remarks by Program Committee Chairs3:30 pm-5:30 pm gcp site tour (optional)Korea National Enterprise for Clinical Trials(Seoul National University Hospital)For International Participants Only

6Welcome ReceptionTuesday, April 26, 2011, 5:30 am-7:00 pmEmerald Hall & FoyerThe Welcome Reception is an excellent opportunity to renew your existing contacts and to make new ones.Network on the Exhibition Floor — Grand Ballroom FoyerMeet with a wide range of companies to learn about new offerings and technologies—all at one event. Virtually every facetof the biopharmaceutical industry and related fields is represented by an exhibitor offering services or products in thisextraordinary exhibit hall marketplace.Exhibition HoursApril 267:30 am - 6:30 pmApril 277:30 am - 5:30 pmApril 287:30 am - 1:30 pmPlease Note: Refreshment breaks will be held in the Grand Ballroom Foyer.Lunches and reception will be held in the Emerald Hall and FoyerGCP Site TourKorea National Enterprise for Clinical TrialsSeoul National University HospitalFor International Participants OnlyThe Korean government has been running a clinical trial research project called KONECT which stands for Korean NationalEnterprise for Clinical Trials over the last couple of years. Currently, the project is carried out by the Seoul National UniversityHospital. The Korea Food and Drug Administration (KFDA) would like to offer international attendees an opportunity to visit theGCP facilities at the University to better understand the current status of clinical trial research in Korea.Plenary Sessions - Grand BallroomParallel Track 1 - Grand Ballroom 1Parallel Track 2 - Grand Ballroom 3Parallel Track 3 - FlamingoThe sessions will be held in the abovemeeting rooms for the entire conference.

Committee/ADVISORY MEMBERSPROGRAM committee ChairAndré W. BroekmansVice President, Most of World Regulatory Policy & RegulatoryAffairs, MSD, The Netherlands(ICH SC and GCG Member)7Chang Won ParkDeputy Director, Drug Approval and Review ManagementDivision, Korea Food and Drug Administration (KFDA),Republic of KoreaPROGRAM Committee Co-ChairKui Lea ParkDirector, Center for Drug Safety Assistance Korea Food andDrug Administration (KFDA), Republic of KoreaSun Hee LeeDirector, Drug Evaluation DepartmentKorea Food and Drug Administration (KFDA),Republic of Korea (ICH GCG Member)Jae-Gook ShinProfessor & DirectorDepartment of Clinical Pharmacology & Clinical Trial CenterInje University Busan Paik Hospital, Republic of KoreaPROGRAM COMMITTEE MEMBERSLaetitia BiggerManager, Regulatory & Scientific Affairs IFPMA, SwitzerlandPatrick K. BradyScientific & Regulatory AffairsPhRMA, USAJulie DennisSenior Director, Worldwide Regulatory Strategy,Emerging Markets, Pfizer, UKWeon DoHead of Regulatory Affairs & Market Access sanofi-aventis,Republic of KoreaZiqun HanManager, Regulatory Policy & Intelligence AbbottLaboratories, UKTiffany HoangRegional Senior ManagerGlobal Regulatory Strategy, Policy & Safety - Asia PacificMSD, SingaporeIn-Jin JangSeoul National University, Republic of KoreaYuppadee JavroongritAssistant Director and Head of InternationalAffairs and IND Section Drug Control Division, Thai FDA,Thailand, (ICH GCG Observer for ASEAN, Co-Chair of ASEANACCSQ PPWG)Tae-Gyun KimDeputy Director, Center for Drug Development AssistanceKorea Food and Drug Administration (KFDA), Republic ofKoreaYil-Seob LeeDirector, Medical & Regulatory Affairs,GlaxoSmithKline, Republic of KoreaJohn C.W. LimChief Executive Officer, Health Sciences Authority (HSA),SingaporeChristina LimGroup Director, Health Products Regulation Group HealthSciences Authority (HSA), Singapore, (ICH GCG Member)Arun MishraDirector, Global Regulatory Affairs GlaxoSmithKline, UKSeiji MiyazawaDirector, International Affairs JPMA, JapanOdette MorinDirector, Regulatory and Scientific Affairs IFPMA, Switzerland(Director of ICH Secretariat, ICH SC and GCG Member)Romi SinghExecutive DirectorGlobal Regulatory Affairs & Safety Amgen, USAJiwung SonHanmi Pharmaceuticals, Republic of KoreaSoo Kyung SuhDeputy Director, Advanced Therapy Products Division KoreaFood and Drug Administration (KFDA), Republic of KoreaAdrian WatersonAsia Regulatory Director, AstraZeneca, UKTae Moo YooDirector, Drug Approval and Review Management Division,Korea Food and Drug Administration (KFDA), Republic ofKoreaADVISORY COMMITTEEYves JuilletDIA President ElectSenior Advisor, LEEM, France, (APEC HarmonizationCenter Advisory Board Member)Tatsuo KurokawaChiba University Graduate School of PharmaceuticalSciences, JapanJustina A. MolzonAssociate Director, International Programs, Center forDrug Evaluation and Research (CDER), Food and DrugAdministration (FDA), USA (ICH SC and GCG Member,Chair of the APEC RHSC Subcommittee on Training)Lembit RägoCoordinator, Quality Assurance & Safety for Medicines(QSM) World Health Organization (WHO), Switzerland,(WHO ICH SC and GCG Observer)Sang-Goo ShinPresidentKoNECT – Korea National Enterprise for Clinical TrialsRepublic of KoreaLarisa Nagra SinghSenior Director, Clinical Operations Asia Pacific, ICONClinical Research, IndiaLing SuSenior Vice President and Head of Development GreaterChina Novartis, P.R. ChinaMike WardManager, International Program Division, Health Productsand Food Branch, Health Canada, Canada, (ICH SC andGCG Member, Chair of the APEC RHSC)

8PARTICIPANTS ALPHABETIZED BY LAST NAMEAccorsi, StefanoChiesi Farmaceutici S.p.AItalyAhn, Mi JiMSD KoreaRepublic of KoreaAn, Hyun JuHandok Pharmaceuticals Co., Ltd.Republic of KoreaBolam, IanGilead Sciences InternationalLimitedUnited KingdomBroekmans, AndreMSDNetherlandsbte Hj Md Jaafar, AminahMinistry of Health,Brunei DarussalamAndo, YukiPharmaceuticals and MedicalDevices AgencyJapanCai, JaneDIAChinaAng, EileenGlaxoSmithkline Pte LtdSingaporeCai, YaGlaxoSmithKline Pte LtdSingaporeAragishi, AtsushiDainippon Sumitomo PharmaJapanChae, ReeHarlan Korea Laboratories, Co., Ltd.Republic of KoreaBae, SoYeonCelltrionRepublic of KoreaBae, YohanBMSRepublic of KoreaBae, Yoon JuLG Life SciencesRepublic of KoreaBae, Young-KyungCJ CheiljedangRepublic of KoreaBae, Go-OonC&C Research LaboratoriesRepublic of KoreaBaek, Sun HyeBayer KoreaRepublic of KoreaBahn, JoonwooAstraZeneca KoreaRepublic of KoreaBaik, JongheebaikIlyang Pharmaceutical Cc., Ltd.Republic of KoreaBaik, Sang HyunChong Kun Dang Bio Corp.Republic of KoreaBang, HyeryunAbbott KoreaRepublic of KoreaBang, JoonSanofi PasteurRepublic of KoreaBigger, LaetitiaIFPMASwitzerlandChahal, BindooBesins Healthcare S.A.ThailandChan, AgnesHealth Sciences AuthoritySingaporeChan, SabrinaThe Hong Kong Association ofthe Pharmaceutical IndustryChinaChang, GraceRDPACChinaChang, JianqingRDPACChinaChang, MikyungBayer Korea Ltd.Republic of KoreaChang, VickyAstellas Pharma Taiwan, Inc.TaiwanChangvisommid, SomthavyFood and Drug Department,Ministry of Health, Lao PDRLao PDRChe, MinheeNovartisRepublic of KoreaChen, DecentBristol-Myers Squibb CompanyTaiwanChen, JenniferRDPACChinaCheng Leng, ChanHealth Sciences AuthoritySingaporeCheon, ChunhooKyung Hee UniversityRepublic of KoreaChoi, JaeYoungBerna Biotech Korea Corp.Republic of KoreaChern, Herng-DerCenter for Drug EvaluationChinese TaipeiChoi, JongtaeGenzyme KoreaRepublic of KoreaCheung, RebeccaFerring Pharmaceuticals Ltd.Hong KongChoi, Jung ALGLSRepublic of KoreaChiu, AmmyTaiwan Daiichisankyo Ltd.TaiwanChoi, KihwanKFDARepublic of KoreaCho, Hea-KyoungBristol-Myers Squibb CompanyRepublic of KoreaChoi, KyungaeCJ JeiljedangRepublic of KoreaCho, HijungNovartis KoreaRepublic of KoreaCho, JaehoonCelltrionRepublic of KoreaCho, Sun HeeEli LillyRepublic of KoreaCho, YeKyungBayer Korea LtdRepublic of KoreaCho, YeongMiGenzyme KoreaRepublic of KoreaCho, YoonJooAstraZenecaRepublic of KoreaCho, YoungHoonSamyang CorporatinonRepublic of KoreaCho, YoungJooWhanIn Pharm.Republic of KoreaChoi, Eun JungUCB KoreaRepublic of KoreaChoi, Eun YoungHandok Pharmaceuticals Co., Ltd.Republic of KoreaChoi, HeijinAstellas Pharma Korea Inc.Republic of KoreaChoi, Hye JinICON Clinical Research Korea Ltd.Republic of KoreaChoi, HyunilSAM Research Institute for Celland Gene TherapyRepublic of KoreaChoi, Paul HS.SilverNet NewsRepublic of KoreaChoi, RachelKHIDIRepublic of KoreaChoi, Yoon YoungMSD KoreaRepublic of KoreaChoi, Young EunBayer KoreaRepublic of KoreaChoi, YunGreen Cross Corp.Republic of KoreaChoi, Yun HwaLilly KoreaRepublic of KoreaChon, Soo AhInvida Korea LimitedRepublic of KoreaChong, SannieHealth Sciences AuthoritySingaporeChow, LilianLundbeck Singapore Pte LtdSingaporeChu, KarenPAREXEL InternationalTaiwanChu, KeeltackSewoncellontech Co., Ltd.Republic of KoreaChu, SandraAbbott Laboratories ServiceCorp. Taiwan BranchTaiwanChun, YunokSanofi PasteurRepublic of KoreaChun, YuraNovartis Korea Ltd.Republic of Korea

9PARTICIPANTS ALPHABETIZED BY LAST NAMEChung, AliciaPAREXEL InternationalTaiwanHa, EunheeNovartis KoreaRepublic of KoreaHong, AhLimMSD KoreaRepublic of KoreaImuta, KaoruKyowa Hakko KirinJapanChung, SeoGreencrossRepublic of KoreaHa, HyunjiBayer KoreaRepublic of KoreaHong, Ji-YoungWyeth KoreaRepublic of KoreaJaehong, KimC&R Research Inc.Republic of KoreaDaniels, MoiraAstraZenecaUnited KingdomHa, Ji WonICON Clinical Research KoreaRepublic of KoreaHong, SungheeHandok PharmaceuticalRepublic of KoreaJae-Hoon, ChoGreencrossRepublic of KoreaDavidson, AlistairAsia-Pacific, PPDUnited KingdomHa, JinnyKHIDIRepublic of KoreaHong, SungInRSP Research Inc.Republic of KoreaJair, RosniDepartment of PharmaceuticalServices, Ministry of HealthBrunei DarussalamDennis, JuliePfizer LtdUnited StatesHa, JuyeonBausch LombRepublic of KoreaHope, PhelpsKellen MeetingsUnited StatesDo, Weonsanofi-aventisRepublic of KoreaHahn, BernardGenentechUnited StatesHu, HeHangzhou MSD PharmaceuticalCo.,Ltd.Beijing BranchChinaJang, Kyung WonKHIDIRepublic of KoreaEisenberg, PaulAmgenUnited StatesHall, PatriciaPharmaNet Ltd.United KingdomHuang, YenlingEli Lilly and CompanyTaiwanJang, SoojungServier KoreaRepublic of KoreaEom, Seong SilAstellas KoreaRepublic of KoreaHan, HyeSeungBerna Biotech KoreaRepublic of KoreaHwang, Il-HyungDaiichisankyo KoreaRepublic of KoreaEom, TaekyoungBayer KoreaRepublic of KoreaHan, SolGlaxoSmithKline KoreaRepublic of KoreaJavroongrit, YuppadeeFood and Drug Administration,Ministry of Public HealthThailandFrance, GeorgesPfizerUnited KingdomHan, ZiqunAbbott LaboratoriesUnited KingdomFujimaru, KiyoshiNiphix KKJapanHeang, Sar KuyBureau of Drug and CosmeticRegistration, Ministry of HealthCambodiaFukuyama, HidenoriShionogi & Co., LtdJapanFuruya, YoshikataMSD K.K.JapanGao, XinjianAstellas Pharma China Inc.ChinaGAO, YanAstraZeneca China,Inc.ChinaGensinger, GaryFood and Drug AdministrationUnited StatesGi, Geun YeongKHIDIRepublic of KoreaGuo, WenyuAstraZeneca PharmaceutialCompanyChinaHwang, JuhaBayer KoreaRepublic of KoreaJang, In-JinSNUHRepublic of KoreaJeon, HyewonBaxterRepublic of KoreaHwang, Woo-JinPfizer Pharmaceuticals KoreaLimitedRepublic of KoreaJeon, Min-jeongSamyang CorporationRepublic of KoreaHyeSun, LimMagistellaRepublic of KoreaJeon, SangheeDaewoong, Pharmaceutical Co., Ltd.Republic of KoreaHyun, Chang JunCJ CheiljaedangRepublic of KoreaJeong, Seong-WonSanofi PasteurRepublic of KoreaHyun, KyongHwaLundbeck Korea Co., Ltd.Republic of KoreaJeong, YeonsimAstraZeneca KoreaRepublic of KoreaHyun, Ye JinGenzyme KoreaRepublic of KoreaJi, Hyi-JeongLGLS, Ltd.Republic of KoreaHyun Nam, RyuLG Life SciencesRepublic of KoreaJieun, LeeUCB Korea Co.,IncRepublic of KoreaHyun Sook, KimCJ Jeiljedang Pharmaceutical BURe

Dr. Seung Hee Kim Director General, National Institute of Food and Drug Safety . Health Sciences (NIHS), Ministry of Health, Labour and Welfare (MHLW), Japan (ICH Q-IWG Member) . Dr. Moira Daniels