ContaCt informationFor general inquiries contact Lisa T. Robinson at

LTRobinson@kellencompany.com

PROGRAM

Presented by

Asia Regulatory Conference:Asia’s Role in Global Drug Development April 26-28, 2011Grand Hilton Hotel Seoul, Republic of Korea

Please Note: Refresment breaks will be held in the Grand Ballroom Foyer. lunches and the reception will be held in the emerald Hall and Foyer.

Worldwide HeadquartersDrug Information Association, Inc.800 Enterprise Road, Suite 200Horsham, PA 19044, USAwww.diahome.org

Regional OfficesBasel, Switzerland Tokyo, Japan Mumbai, India Beijing, China

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ContaCt informationFor general inquiries and registration, contact Lisa T. Robinson at LTRobinson@kellencompany.com

Welcome

TABLE of Contents Page

• Agenda 1-6

• Program Committee List 7

• Advisory Committee List 7

• Participant List 8-15

• Exhibitor List/Floorplan 16

• Advertisement 17

• Biographies 18-24

1

DAy 1 | tuesday, april 26

7:30 am-8:30 am CONFERENCE REGISTRATION

9:00 am-9:40 am OpENING CEREmONySeSSion ChairS

Dr. Sun Hee LeeDirector, Drug Evaluation Department, Korea Food & Drug Administration (KFDA), Republic of Korea (ICH Global Cooperation Group (GCG) Member)

Dr. André W. BroekmansVice President, Most of World Regulatory Policy & Regulatory Affairs, MSD, The Netherlands (Program Committee Chair, ICH Steering Committee (SC) Member)

Opening RemarksDr. Seung Hee KimDirector General, National Institute of Food and Drug Safety Evaluation, Korea Food & Drug Administration (KFDA), Republic of Korea (Director of APEC Harmonization Center)

Congratulatory RemarksDr. Yun Hong NohCommissioner, Korea Food & Drug Administration (KFDA), Republic of Korea

Congratulatory RemarksDr. Bup Wan KimPresident, Korea Health Industry Development Institute, (KHIDI), Republic of Korea

Welcome from the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA)Dr. Odette MorinDirector, Regulatory and Scientific Affairs, IFPMA, Switzerland (Director of ICH Secretariat, ICH SC and GCG Member)

Welcome from the Drug Information Association (DIA)Dr. Yves JuilletDIA President Elect

9:40 am–10:00 am REFREShmENT BREAk

10:00 am–12:00 pm plENARy SESSIONUpdate on ICh Activities, Focus on New ActivitiesSeSSion ChairS

Dr. Sun Hee LeeDirector, Drug Evaluation Department, Korea Food & Drug Administration (KFDA), Republic of Korea (ICH GCG Member)

Dr. André W. BroekmansVice President, Most of World Regulatory Policy & Regulatory Affairs, MSD, The Netherlands (Program Committee Chair, ICH SC and GCG member)

20 Years of ICH: Learning and AccomplishmentsDr. Justina A. MolzonAssociate Director, International Programs, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), USA (ICH SC and GCG Member, Chair of the APEC RHSC Subcommittee on Training)

Japan’s Experience with ICH and the Implementation of GuidelinesMr. Shinobu UzuDirector, International Planning, Ministry of Health, Labour and Welfare (MHLW), Japan (ICH SC Member and GCG Co-Chair)

Expanding Participation in ICH Technical Working Groups to Regional Harmonization Initiatives (RHIs) and Drug Regulatory Agencies (DRAs)Mr. Mike WardManager, International Program Division, Health Products and Food Branch, Health Canada, Canada, (ICH SC and GCG Member, Chair of the APEC RHSC)

KFDA’s Perspectives on the Implementation of ICH Guidelines Dr. Sun Hee LeeDirector, Drug Evaluation Department, Korea Food & Drug Administration (KFDA), Republic of Korea (ICH GCG Member)

12:00 pm-1:00 pm lUNCh BREAk

1:00 pm–3:30 pm plENARy SESSION Regional harmonization InitiativesSeSSion ChairS

Dr. Justina A. MolzonAssociate Director, International Programs, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), USA (ICH SC and GCG Member, Chair of the APEC RHSC Subcommittee on Training)

Ms. Weon DoHead of Regulatory Affairs and Market Access, sanofi-aventis, Republic of Korea

The Role of APEC in Advancing Harmonization Efforts in a More Strategic, Effective and Sustainable FashionMr. Mike WardManager, International Program Division, Health Products and Food Branch, Health Canada, Canada, (ICH SC and GCG Member, Chair of the APEC RHSC)

AHC Activities: Current Status and Future Prospects Dr. Kui Lea ParkDirector, Center for Drug Development Assistance, Korea Food & Drug Administration (KFDA), Republic of Korea

ASEAN Regulatory Harmonization Activities and Future PerspectivesDr. Yuppadee JavroongritAssistant Director & Head of International Affairs & IND Section Drug Control Division, Food and Drug Administration (FDA), Ministry of Public Health, Thailand (ASEAN ICH GCG Observer, Co-Chair of ASEAN ACCSQ PPWG)

Tripartite Symposium on Rationalization of Clinical Trial RequirementsMs. Hee Young ParkKorea Food & Drug Administration (KFDA), Republic of Korea Mr. Shinobu UzuDirector, International Planning, Ministry of Health, Labour and Welfare (MHLW), Japan (ICH SC Member and GCG Co-Chair) Dr. Li JinjuDivision Director, Division of Drug Research Supervision Department of Drug Registration, State Food and Drug Administration (SFDA), P.R. China

3:30 pm–4:00 pm REFREShmENT BREAk

(to be confirmed)

Mr. Ding JianhuaDeputy Director General, Department of Inter-national Cooperation, State Food and Drug Administra-tion (SFDA), P.R. China (ICH GCG Member) (to be confirmed)Dr. Tae-Gyun KimKFDA (to be confirmed)

aGenda

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Experience and Value of CTD Ms. Jalene PohRegulatory Consultant, Pharmaceuticals & Biologics Branch, Pre-Marketing Division, Health Products Regulatory Group, Health Sciences Authority (HSA), Singapore

Practical Use of ICH CTD in Facilitating Approval of Prequalification of Pharmaceutical Products and the Benefits to the WHO ProgramDr. Lembit RägoCoordinator, Quality Assurance & Safety for Medicines (QSM), Essential Medicines Pharmaceutical Policies Department, World Health Organization (WHO), Switzerland (WHO ICH SC and GCG Observer)

Practical Use and Value of CTD in Clinical Trials and New Drug Application (NDA), and Challenges Faced in the Asia RegionMr. Alistair DavidsonSenior Director, Regulatory Affairs, Asia-Pacific, PPD, UK

Track 3: practical Uses of Common Technical Documents (CTDs) in Asia SeSSion ChairS

Dr. Lembit RägoCoordinator, Quality Assurance & Safety for Medicines (QSM), Essential Medicines Pharmaceutical Policies Department, World Health Organization (WHO), Switzerland (WHO ICH SC and GCG Observer)

Mr. Kum Cheun WongDirector, Global Regulatory Policy & Intelligence, Asia Pacific, Johnson & Johnson, Singapore

ICH Q-IWG Updates and Challenges Dr. Georges FranceVice President, Global Quality Strategy and International Affiliate Quality and Compliance (IAQC), Pfizer, UK (ICH Quality Implementation Working Group (ICH Q-IWG) Member)

Dr. Jean-Louis RobertHead of Division, National Health Laboratory, Department of Quality Control of Medicine, Luxembourg (Rapporteur of ICH Q-IWG)

CMC Requirements to Support New Technology in Development and Analytical Methods (e.g. NIR, UPLC)Dr. Moheb NasrDirector, Office of New Drug Quality, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), USA (ICH Q-IWG Member)

Validation and Continuous Verification: Regulatory Challenges Dr. Yukio HiyamaChief, Third Section, Division of Drugs, National Institute of Health Sciences (NIHS), Ministry of Health, Labour and Welfare (MHLW), Japan (ICH Q-IWG Member)

Track 2: Ensuring Quality – Enhance the Approach of Quality Driven by ICh Q8, Q9, Q10, and Q11: What about practical Implementation?SeSSion ChairS

Dra. KustantinahHead, National Agency of Drug and Food Control (NA-DFC/BPOM), Indonesia

Dr. Georges FranceVice President, Global Quality Strategy and International Affiliate Quality and Compliance (IAQC), Pfizer, UK (ICH Quality Implementation Working Group (ICH Q-IWG) Member)

5:30 pm-7:00 pm    Welcome Reception — Emerald hall & Foyer

4:00 pm-5:30 pm    parallel traCks

Counterfeit Medicines in Asia TodayMr. Thomas KubicPresident and CEO of the Pharmaceutical Security Institute, USA

The Malaysian Experience with MeditagDato’ Eishah A. RahmanSenior Director, Pharmaceutical Services Division, Ministry of Health, Malaysia

Singapore’s Experience in the Fight Against Counterfeits Ms. Ruth Lee Choo AiActing Director, Enforcement Branch, Health Products Regulation Group, Health Sciences Authority (HSA), Singapore

Track 1: Fighting Counterfeit medicines in Emerging Countries: Addressing Infrastructure and Capacity Gaps SeSSion ChairS

Dato’ Eishah A. RahmanSenior Director, Pharmaceutical Services Division, Ministry of Health, Malaysia

Mr. Arun MishraDirector, Global Regulatory Affairs, GlaxoSmithKline, UK

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Participation in Asia in Global Pediatric Programs, Including Cultural Barriers to Conduct Pediatric Clinical TrialsDr. Hidefumi NakamuraDirector, Division of Clinical Research, National Center for Child Health and Development, Japan

How to Extrapolate Clinical Development Results to Asia Children: Usefulness of Bridging the Program with AdultsDr. An VermeulenHead, Modeling & Simulation Department, Johnson & Johnson, Belgium

FDA’s Experience with Global Pediatric DevelopmentDr. Jean W. TemeckLead Medical Officer, Office of Pediatric Therapeutics (OPT), Office of International and Special Programs (OISP), Office of the Commissioner (OC), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), USA

Position of WHO ICDRA on Global Pediatric Development Ms. Agnes ChanRegulatory Consultant, Pharmaceuticals & Biologics Branch, Health Products Regulation Group, Health Sciences Authority (HSA), Singapore

Track 1: Establishing the Asia pacific Region as an Important partner in Global pediatric Development SeSSion ChairS

Dr. Min Soo ParkDirector, Clinical Trials Center, Chair, Department of Clinical Pharmacology, Yonsei University, Republic of Korea

Mrs. Angelika JoosHead, Regulatory Policy, EU & Most of World, MSD (Europe), Belgium

1:30 pm-3:30 pm    parallel traCks

DAy 2 | Wednesday, april 27

8:30 am–10:00 am plENARy SESSIONEarly Clinical Development in AsiaSeSSion ChairS

Professor In-Jin JangSeoul National University, Republic of Korea

Dr. A. RamkishanAsst. Drugs Controller, CDSCO, Sub Zonal Office, India

Current Status of Early Clinical Development in Asia and Plan for the Future: Industry PerspectiveDr. Ken KobayashiHead of Clinical Science Oncology, Johnson & Johnson, Japan

Regulatory Experience in Early Clinical Trial Approval Dr. A. RamkishanAsst. Drugs Controller, CDSCO, Sub Zonal Office, India

How Asian Clinical Sites are Working for Early Clinical TrialsProfessor In-Jin JangSeoul National University, Republic of Korea

10:00 am–10:30 am REFREShmENT BREAk

10:30 am–12:30 pm plENARy SESSIONlate Clinical Development in AsiaSeSSion ChairS

Dr. Herng-Der ChernDistinguished Researcher, Center for Drug Evaluation (CDE), Chinese Taipei

Mr. Adrian WatersonAsia Regulatory Director, AstraZeneca, UK

Simultaneous Multi-regional Clinical TrialsDr. Moira DanielsVice President, Regulatory Affairs, AstraZeneca, UK

Acceptance of Clinical Data – The Challenge of GeneralizabilityDr. Yuki AndoPrincipal Reviewer of Biostatistics, Office of New Drug II, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Towards Simultaneous Regulatory ApprovalDr. Herng-Der ChernDistinguished Researcher, Center for Drug Evaluation (CDE), Chinese Taipei

12:30 pm-1:30 pm lUNCh BREAk

Track 2: Ensuring Quality: harmonizing and Optimizing Inspection Approach in the Global EnvironmentSeSSion ChairS

Dr. Yukio HiyamaChief, Third Section, Division of Drugs, National Institute of Health Sciences (NIHS), Ministry of Health, Labour and Welfare (MHLW), Japan (ICH Q-IWG Member)

Dr. Georges FranceVice President, Global Quality Strategy and International Affiliate Quality and Compliance (IAQC), Pfizer UK (ICH Q-IWG Member)

(Parallel tracks continued on next page)

Control Strategy and Batch Release: Challenges for a Global and an Harmonized ApproachDr. Jacques MorénasAssistant Director, Inspectorate and Companies Depart-ment, The French Health Products Safety Agency (AFS-SAPS), France (ICH Q-IWG Member, PIC/S)

Quality Risk Management in the WHO Prequalification ProcessDr. Lembit RägoCoordinator, Quality Assurance & Safety for Medicines (QSM), Essential Medicines Pharmaceutical Policies Department, World Health Organization (WHO), Switzerland (WHO ICH SC and GCG Observer)

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Latest Developments on Ethical Business Practices (EBP) in Australia Dr. Megan Keaney

Principal Medical Adviser, Therapeutic Goods Administration (TGA), AustraliaMs. Deborah MonkDirector, Innovation and Industry Policy, Medicines Australia, Australia

Update on New RDPAC Code and Latest Developments in ChinaMs. Jennifer ChenDirector, Legal Affairs, R&D-based Pharmaceutical Association Committee (RDPAC), P.R. China

Code Compliance Governance in Japan Mr. Yota KikuchiManager, Promotion Code & Public Affairs, sanofi-aventis, Japan (Vice Chair of Japan Pharmaceutical Manufacturers Association (JPMA) Promotion Code Working Committee)

Track 3: Ethical Business practices: Towards Better marketing ComplianceSeSSion ChairS

Dr. Megan KeaneyPrincipal Medical Adviser, Therapeutic Goods Administration (TGA), Australia

Mr. In-Bum KimSr. Director, Korean Research-based Pharmaceutical Industry Association (KRPIA), Republic of Korea

3:30 pm–4:00 pm REFREShmENT BREAk

4:00 pm–5:30 pm plENARy SESSIONSimilar Biotherapeutic products (SBps) in Asia: Opportunities and Challenges in Regulatory EvaluationSeSSion ChairS

Dr. Rohan HammettNational Manager, Therapeutic Goods Administration (TGA), Australia (to be confirmed)

API: Role of EDQM in Globalization, Input on Inspections and StandardsDr. Susanne KeitelDirector, European Directorate for the Quality of Medicines & Healthcare (EDQM), Council of Europe, France

Panel Discussion: CMC Harmonization and Regulatory ChallengesChair

Dr. Georges FranceVice President, Global Quality Strategy and International Affiliate Quality and Compliance (IAQC), Pfizer UK (ICH Q-IWG Member)PaneliStS

Dr. Moheb NasrDirector, Office of New Drug Quality, Center for Drug Evaluation and Research (CDER), Food and Drug Adminis-tration (FDA), USA (ICH Q-IWG Member) Dr. Yukio HiyamaChief, Third Section, Division of Drugs, National Institute of Health Sciences (NIHS), Ministry of Health, Labour and Welfare (MHLW), Japan (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 SC and GCG Observer) Dr. Susanne KeitelDirector, European Directorate for the Quality of Medicines & Healthcare (EDQM), Council of Europe, France Dra. KustantinahHead, National Agency of Drug and Food Control (NA-DFC/BPOM), Indonesia

1:30 pm-3:30 pm    parallel traCks (Continued)

(session continued on next page)

Dr. Sannie ChongActing Director, Generics and Biosimilars Branch, Health Sciences Authority (HSA), Singapore

Dr. Fermin Ruiz de ErenchumLeader, Special Regulatory Task Force, Hoffmann-La Roche Ltd., Switzerland (Chair of IFPMA Biotherapeutic Group)

Do We Have a Common Understanding? Definitions of SBPs and Key Principles in Evaluating SBPsDr. Peter RichardsonResponsible for Biological Quality of Medicines, Human Medicines Development and Evaluation, European Medicines Agency (EMA), UK

Evolving Regulatory Landscape for SBPs in Asia Dr. Fermin Ruiz de ErenchumLeader, Special Regulatory Task Force, Hoffmann-La Roche Ltd., Switzerland (Chair of IFPMA Biotherapeutic Group)

Chinese Taipei’s Perspectives of Regulation of Biosimilar MedicineMs. Joyce WangDivision of Drugs & New Biotechnology Products, Food and Drug Administration, Department of Health, Chinese Taipei

5

DAy 3 | thursday, april 28

8:30 am–10:00 am plENARy SESSIONElectronic Submissions and eCTD as Vehicle to Reconcile Differences in Technical Regulatory RequirementsSeSSion ChairS

Mr. Gary M. GensingerDeputy Director, Office of Business Informatics, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), USA

Mr. John W. KiserSenior Director, Global Pharmaceutical Regulatory Affairs, Submission Operations & Strategic Initiatives, Abbott Laboratories, USA

The Advantages and Challenges of Electronic Regulatory Submissions in eCTD and Non-eCTD Electronic Submissions (NeeS) Formats – An Industry PerspectiveMr. John W. KiserSenior Director, Global Pharmaceutical Regulatory Affairs, Submission Operations & Strategic Initiatives, Abbott Laboratories, USA

Benefits to Implementing eCTD – A Regulatory PerspectiveMr. Gary M. GensingerDeputy Director, Office of Business Informatics, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), USA

Practical Use and Challenges Faced – An Asian Regulator PerspectiveMs. Jalene PohRegulatory Consultant, Pharmaceuticals & Biologics Branch, Pre-Marketing Division, Health Products Regulation Group, Health Sciences Authority (HSA), Singapore

10:00 am-10:30 am REFREShmENT BREAk

10:30 am-12:30 pm plENARy SESSIONpharmacovigilance: how Do Regulatory Agencies and Industry Work Together to protect patients?SeSSion ChairS

Dr. Suzette Henares-LazoActing Director IV, Food and Drug Administration (FDA), Philippines

Dr. Paul EisenbergSenior Vice President, Global Regulatory Affairs and Safety, Amgen, USA

Current Status and New Directions for Pharmacovigilance in KoreaDr. Joungwon OhDeputy Director, Pharmaceutical Safety Bureau, Korea Food and Drug Administration (KFDA), Republic of Korea

Integrating Risk Management into Global Drug Development – Opportunities and ChallengesDr. Paul EisenbergSenior Vice President, Global Regulatory Affairs and Safety, Amgen, USA

Post-Marketed Surveillance – A Shared ResponsibilityDr. Rebecca WangHead of Drug Safety Operation, Regional Center for Asia Pacific, Roche, P.R. China

The Role of MedDRA in Pharmacovigilance ActivitiesDr. Patricia MozzicatoChief Medical Officer, MedDRA Maintenance & Support Services Organization (MSSO), USA

12:30 pm–1:30 pm lUNCh BREAk

1:30 pm–3:00 pm plENARy SESSIONGood Regulatory practices, Including Assessment Report, Efficient Use of Certificate of pharmaceutical product (Cpps) and TransparencySeSSion ChairS

Dr. Megan KeaneyPrincipal Medical Adviser, Therapeutic Goods Administration (TGA), Australia

Dr. Yves JuilletDIA President ElectSenior Advisor, LEEM, France, (APEC HarmonizationCenter Advisory Board Member)

Good Regulatory Practices: Do We Have a Common Understanding?

Dr. Yoshiaki UyamaDirector, Division of Regulatory Research, Office of Regulatory Science, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Opportunities for Industry to Partner with Drug Regulatory Authorities (DRAs) to Further Good Regulatory PracticesDr. Romi SinghExecutive Director, Global Regulatory Affairs & Safety, Amgen, USA

Efficient Use of CPPsDr. Lembit RägoCoordinator, Quality Assurance & Safety for Medicines (QSM), Essential Medicines Pharmaceutical Policies Department, World Health Organization (WHO), Switzerland (WHO ICH SC and GCG Observer)

3:00 pm-3:10 pm Closing Remarks by program Committee Chairs

3:30 pm-5:30 pm GCp SITE TOUR (OpTIONAl)Korea National Enterprise for Clinical Trials

(Seoul National University Hospital)

For International Participants Only

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Welcome ReceptionTUESDAY, APRIL 26, 2011, 5:30 am-7:00 pm

Emerald Hall & Foyer

The Welcome Reception is an excellent opportunity to renew your existing contacts and to make new ones.

Network on the Exhibition Floor — Grand Ballroom Foyer

Meet with a wide range of companies to learn about new offerings and technologies—all at one event. Virtually every facet of the biopharmaceutical industry and related fields is represented by an exhibitor offering services or products in this extraordinary exhibit hall marketplace.

Exhibition Hours

April 26 7:30 am - 6:30 Pm

April 27 7:30 am - 5:30 Pm

April 28 7:30 am - 1:30 Pm

Please Note: Refreshment breaks will be held in the Grand Ballroom Foyer. lunches and reception will be held in the emerald Hall and Foyer

GCP Site TourKorea National Enterprise for Clinical Trials

Seoul National University Hospital

For International Participants Only

The Korean government has been running a clinical trial research project called KONECT which stands for Korean National Enterprise for Clinical Trials over the last couple of years. Currently, the project is carried out by the Seoul National University Hospital. The Korea Food and Drug Administration (KFDA) would like to offer international attendees an opportunity to visit the GCP 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 - Flamingo

The sessions will be held in the above meeting rooms for the entire conference.

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PROGRAM COMMITTEE CHAIR

André W. BroekmansVice President, Most of World Regulatory Policy & Regulatory Affairs, MSD, The Netherlands(ICH SC and GCG Member)

PROGRAM COMMITTEE CO-CHAIR

Sun Hee LeeDirector, Drug Evaluation DepartmentKorea Food and Drug Administration (KFDA), Republic of Korea (ICH GCG Member)

PROGRAM COMMITTEE MEMBERS

Laetitia BiggerManager, Regulatory & Scientific Affairs IFPMA, Switzerland

Patrick K. BradyScientific & Regulatory AffairsPhRMA, USA

Julie DennisSenior Director, Worldwide Regulatory Strategy,Emerging Markets, Pfizer, UK

Weon DoHead of Regulatory Affairs & Market Access sanofi-aventis, Republic of Korea

Ziqun HanManager, Regulatory Policy & Intelligence Abbott Laboratories, UK

Tiffany HoangRegional Senior ManagerGlobal Regulatory Strategy, Policy & Safety - Asia Pacific MSD, Singapore

In-Jin JangSeoul National University, Republic of Korea

Yuppadee JavroongritAssistant Director and Head of International Affairs and IND Section Drug Control Division, Thai FDA, Thailand, (ICH GCG Observer for ASEAN, Co-Chair of ASEAN ACCSQ PPWG)

Tae-Gyun KimDeputy Director, Center for Drug Development Assistance Korea Food and Drug Administration (KFDA), Republic of Korea

Yil-Seob LeeDirector, Medical & Regulatory Affairs, GlaxoSmithKline, Republic of Korea

John C.W. LimChief Executive Officer, Health Sciences Authority (HSA), Singapore

Christina LimGroup Director, Health Products Regulation Group Health Sciences Authority (HSA), Singapore, (ICH GCG Member)

Arun MishraDirector, Global Regulatory Affairs GlaxoSmithKline, UK

Seiji MiyazawaDirector, International Affairs JPMA, Japan

Odette MorinDirector, Regulatory and Scientific Affairs IFPMA, Switzerland(Director of ICH Secretariat, ICH SC and GCG Member)

Chang Won ParkDeputy Director, Drug Approval and Review Management Division, Korea Food and Drug Administration (KFDA), Republic of Korea

Kui Lea ParkDirector, Center for Drug Safety Assistance Korea Food and Drug Administration (KFDA), Republic of Korea

Jae-Gook ShinProfessor & DirectorDepartment of Clinical Pharmacology & Clinical Trial Center Inje University Busan Paik Hospital, Republic of Korea

Romi SinghExecutive DirectorGlobal Regulatory Affairs & Safety Amgen, USA

Jiwung SonHanmi Pharmaceuticals, Republic of Korea

Soo Kyung SuhDeputy Director, Advanced Therapy Products Division Korea Food and Drug Administration (KFDA), Republic of Korea

Adrian WatersonAsia Regulatory Director, AstraZeneca, UK

Tae Moo YooDirector, Drug Approval and Review Management Division,Korea Food and Drug Administration (KFDA), Republic of Korea

ADVISORY COMMITTEE

Yves JuilletDIA President ElectSenior Advisor, LEEM, France, (APEC Harmonization Center Advisory Board Member)

Tatsuo KurokawaChiba University Graduate School of Pharmaceutical Sciences, Japan

Justina A. MolzonAssociate Director, International Programs, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (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 Trials Republic of Korea

Larisa Nagra SinghSenior Director, Clinical Operations Asia Pacific, ICON Clinical Research, India

Ling SuSenior Vice President and Head of Development Greater China Novartis, P.R. China

Mike WardManager, International Program Division, Health Products and Food Branch, Health Canada, Canada, (ICH SC and GCG Member, Chair of the APEC RHSC)

Committee/adVisory memBers

8partiCipants aLpHaBETIZED BY LaST NamE

Accorsi, StefanoChiesi Farmaceutici S.p.AItaly

Ahn, Mi JiMSD KoreaRepublic of Korea

An, Hyun JuHandok Pharmaceuticals Co., Ltd.Republic of Korea

Ando, YukiPharmaceuticals and Medical Devices AgencyJapan

Ang, EileenGlaxoSmithkline Pte LtdSingapore

Aragishi, AtsushiDainippon Sumitomo PharmaJapan

Bae, SoYeonCelltrionRepublic of Korea

Bae, YohanBMSRepublic of Korea

Bae, Yoon JuLG Life SciencesRepublic of Korea

Bae, Young-KyungCJ CheiljedangRepublic of Korea

Bae, Go-OonC&C Research LaboratoriesRepublic of Korea

Baek, Sun HyeBayer KoreaRepublic of Korea

Bahn, JoonwooAstraZeneca KoreaRepublic of Korea

Baik, JongheebaikIlyang Pharmaceutical Cc., Ltd.Republic of Korea

Baik, Sang HyunChong Kun Dang Bio Corp.Republic of Korea

Bang, HyeryunAbbott KoreaRepublic of Korea

Bang, JoonSanofi PasteurRepublic of Korea

Bigger, LaetitiaIFPMASwitzerland

Bolam, IanGilead Sciences International LimitedUnited Kingdom

Broekmans, AndreMSDNetherlands

bte Hj Md Jaafar, AminahMinistry of Health, Brunei Darussalam

Cai, JaneDIAChina

Cai, YaGlaxoSmithKline Pte LtdSingapore

Chae, ReeHarlan Korea Laboratories, Co., Ltd.Republic of Korea

Chahal, BindooBesins Healthcare S.A.Thailand

Chan, AgnesHealth Sciences AuthoritySingapore

Chan, SabrinaThe Hong Kong Association of the Pharmaceutical IndustryChina

Chang, GraceRDPACChina

Chang, JianqingRDPACChina

Chang, MikyungBayer Korea Ltd.Republic of Korea

Chang, VickyAstellas Pharma Taiwan, Inc.Taiwan

Changvisommid, SomthavyFood and Drug Department, Ministry of Health, Lao PDRLao PDR

Che, MinheeNovartisRepublic of Korea

Chen, DecentBristol-Myers Squibb CompanyTaiwan

Chen, JenniferRDPACChina

Cheng Leng, ChanHealth Sciences AuthoritySingapore

Cheon, ChunhooKyung Hee UniversityRepublic of Korea

Chern, Herng-DerCenter for Drug EvaluationChinese Taipei

Cheung, RebeccaFerring Pharmaceuticals Ltd.Hong Kong

Chiu, AmmyTaiwan Daiichisankyo Ltd.Taiwan

Cho, Hea-KyoungBristol-Myers Squibb CompanyRepublic of Korea

Cho, HijungNovartis KoreaRepublic of Korea

Cho, JaehoonCelltrionRepublic of Korea

Cho, Sun HeeEli LillyRepublic of Korea

Cho, YeKyungBayer Korea LtdRepublic of Korea

Cho, YeongMiGenzyme KoreaRepublic of Korea

Cho, YoonJooAstraZenecaRepublic of Korea

Cho, YoungHoonSamyang CorporatinonRepublic of Korea

Cho, YoungJooWhanIn Pharm.Republic of Korea

Choi, Eun JungUCB KoreaRepublic of Korea

Choi, Eun YoungHandok Pharmaceuticals Co., Ltd.Republic of Korea

Choi, HeijinAstellas Pharma Korea Inc.Republic of Korea

Choi, Hye JinICON Clinical Research Korea Ltd.Republic of Korea

Choi, HyunilSAM Research Institute for Cell and Gene TherapyRepublic of Korea

Choi, JaeYoungBerna Biotech Korea Corp.Republic of Korea

Choi, JongtaeGenzyme KoreaRepublic of Korea

Choi, Jung ALGLSRepublic of Korea

Choi, KihwanKFDARepublic of Korea

Choi, KyungaeCJ JeiljedangRepublic of Korea

Choi, Paul HS.SilverNet NewsRepublic of Korea

Choi, RachelKHIDIRepublic of Korea

Choi, Yoon YoungMSD KoreaRepublic of Korea

Choi, Young EunBayer KoreaRepublic of Korea

Choi, YunGreen Cross Corp.Republic of Korea

Choi, Yun HwaLilly KoreaRepublic of Korea

Chon, Soo AhInvida Korea LimitedRepublic of Korea

Chong, SannieHealth Sciences AuthoritySingapore

Chow, LilianLundbeck Singapore Pte LtdSingapore

Chu, KarenPAREXEL InternationalTaiwan

Chu, KeeltackSewoncellontech Co., Ltd.Republic of Korea

Chu, SandraAbbott Laboratories Service Corp. Taiwan BranchTaiwan

Chun, YunokSanofi PasteurRepublic of Korea

Chun, YuraNovartis Korea Ltd.Republic of Korea

9

Chung, AliciaPAREXEL InternationalTaiwan

Chung, SeoGreencrossRepublic of Korea

Daniels, MoiraAstraZenecaUnited Kingdom

Davidson, AlistairAsia-Pacific, PPDUnited Kingdom

Dennis, JuliePfizer LtdUnited States

Do, Weonsanofi-aventisRepublic of Korea

Eisenberg, PaulAmgenUnited States

Eom, Seong SilAstellas KoreaRepublic of Korea

Eom, TaekyoungBayer KoreaRepublic of Korea

France, GeorgesPfizerUnited Kingdom

Fujimaru, KiyoshiNiphix KKJapan

Fukuyama, HidenoriShionogi & Co., LtdJapan

Furuya, YoshikataMSD K.K.Japan

Gao, XinjianAstellas Pharma China Inc.China

GAO, YanAstraZeneca China,Inc.China

Gensinger, GaryFood and Drug Administration United States

Gi, Geun YeongKHIDIRepublic of Korea

Guo, WenyuAstraZeneca Pharmaceutial CompanyChina

Ha, EunheeNovartis KoreaRepublic of Korea

Ha, HyunjiBayer KoreaRepublic of Korea

Ha, Ji WonICON Clinical Research KoreaRepublic of Korea

Ha, JinnyKHIDIRepublic of Korea

Ha, JuyeonBausch + LombRepublic of Korea

Hahn, BernardGenentechUnited States

Hall, PatriciaPharmaNet Ltd.United Kingdom

Han, HyeSeungBerna Biotech KoreaRepublic of Korea

Han, SolGlaxoSmithKline KoreaRepublic of Korea

Han, ZiqunAbbott LaboratoriesUnited Kingdom

Heang, Sar KuyBureau of Drug and Cosmetic Registration, Ministry of Health Cambodia

Henares-Lazo, SuzettePhillippines FDAPhilippines

Heng, ChristineCelgene Pte LtdSingapore

Hengrasme, BoosbaBaker & McKenzieThailand

Heo, EunkyungC&R Research Inc.Republic of Korea

Hirai, KanjiPfizer Japan Inc.Japan

Hiyama, YukioNational Institute of Health SciencesJapan

Hoang, TiffanyMSDSingapore

Hong, AhLimMSD KoreaRepublic of Korea

Hong, Ji-YoungWyeth KoreaRepublic of Korea

Hong, SungheeHandok PharmaceuticalRepublic of Korea

Hong, SungInRSP Research Inc.Republic of Korea

Hope, PhelpsKellen MeetingsUnited States

Hu, HeHangzhou MSD Pharmaceutical Co.,Ltd.Beijing BranchChina

Huang, YenlingEli Lilly and CompanyTaiwan

Hwang, Il-HyungDaiichisankyo KoreaRepublic of Korea

Hwang, JuhaBayer KoreaRepublic of Korea

Hwang, Woo-JinPfizer Pharmaceuticals Korea LimitedRepublic of Korea

HyeSun, LimMagistellaRepublic of Korea

Hyun, Chang JunCJ CheiljaedangRepublic of Korea

Hyun, KyongHwaLundbeck Korea Co., Ltd.Republic of Korea

Hyun, Ye JinGenzyme KoreaRepublic of Korea

Hyun Nam, RyuLG Life SciencesRepublic of Korea

Hyun Sook, KimCJ Jeiljedang Pharmaceutical BURepublic of Korea

Hyun-Suk, MinGreencrossRepublic of Korea

Imatsu, HozuiASKLEP Inc.Japan

Imuta, KaoruKyowa Hakko KirinJapan

Jaehong, KimC&R Research Inc.Republic of Korea

Jae-Hoon, ChoGreencrossRepublic of Korea

Jair, RosniDepartment of Pharmaceutical Services, Ministry of HealthBrunei Darussalam

Jang, In-JinSNUHRepublic of Korea

Jang, Kyung WonKHIDIRepublic of Korea

Jang, SoojungServier KoreaRepublic of Korea

Javroongrit, YuppadeeFood and Drug Administration, Ministry of Public HealthThailand

Jeon, HyewonBaxterRepublic of Korea

Jeon, Min-jeongSamyang CorporationRepublic of Korea

Jeon, SangheeDaewoong, Pharmaceutical Co., Ltd.Republic of Korea

Jeong, Seong-WonSanofi PasteurRepublic of Korea

Jeong, YeonsimAstraZeneca KoreaRepublic of Korea

Ji, Hyi-JeongLGLS, Ltd.Republic of Korea

Jieun, LeeUCB Korea Co.,IncRepublic of Korea

Jihyoun, LimServier KoreaRepublic of Korea

Jinhee, KimServier KoreaRepublic of Korea

Jinju, LiState Food and Drug Administration (SFDA)China

partiCipants aLpHaBETIZED BY LaST NamE

10

Jo, TaeyounMSD KoreaRepublic of Korea

Joo, SunghyunBerna Biotech Korea Corp.Republic of Korea

Joos, AngelikaMerck Sharp & Dohme (Europe), Inc.Belgium

Ju, In SookKRPIARepublic of Korea

Juillet, YvesLEEMFrance

Jun, Dong-hoWhanin Pharm Co., Ltd.Republic of Korea

Jung, Eun-MiPfizer KoreaRepublic of Korea

Jung, Hyung-JinPfizer KoreaRepublic of Korea

Jung, JihyeKorea Otsuka International Asia ArabRepublic of Korea

Jung, MijinNovartis KoreaRepublic of Korea

Jung, MinjungUCB Korea Pharmaceuticals Ltd.Republic of Korea

Jung, YeiLiLG Life Sciences,Ltd.Republic of Korea

Jung, YoomiFreseniusKabiRepublic of Korea

Kang, BoseongKuhnil PharmRepublic of Korea

Kang, Bu Imsanofi-aventis KoreaRepublic of Korea

Kang, ChangmoLG Life SciencesRepublic of Korea

Kang, Dae JoonCKD Bio Corp.Republic of Korea

Kang, HyerimKorea UCB Co., LTDRepublic of Korea

Kang, Hyo-SeonAstraZececa KoreaRepublic of Korea

Kang, HyunjuRoche Korea/Regulatory AffairsRepublic of Korea

Kang, Jaw-JouTaiwan Food & Drug AdministrationTaiwan

Kang, SeongsikMSD KoreaRepublic of Korea

Kang, SylviaParexel KoreaRepublic of Korea

Kaur, KirpalBristol-Myers Squibb AustraliaAustralia

Kearney, MeganTherapeutic Goods Administration (TGA)Australia

Keitel, SusanneEDQMFrance

Keok, ChristinaBristol-Myers Squibb Pte LtdSingapore

Kikuchi, Yotasanofi-aventisJapan

Kikuchi, YukoEisai Co., Ltd.Japan

Kim, AhranBoehringer Ingelheim Korea Ltd.Republic of Korea

Kim, Ah-youngFresenius Kabi KoreaRepublic of Korea

Kim, BoyeonKorea Food & Drug AdministrationRepublic of Korea

Kim, BoyoungBausch + LombRepublic of Korea

Kim, Bup WanKHIDIRepublic of Korea

Kim, ByungjinR&P KoreaRepublic of KoreaKim, ChangheeUCB KoreaRepublic of Korea

Kim, ChinChong Kun Dang Pharmaceutical Corp.Republic of Korea

Kim, Dong EonIlyang Pharmaceutical Co., Ltd.Republic of Korea

Kim, DongMinCelltrion, Inc.Republic of Korea

Kim, EricKHIDIRepublic of Korea

Kim, EuiJinCelltrion, Inc.Republic of Korea

Kim, Eun AhLSK Global Pharma ServicesRepublic of Korea

Kim, Eun-gyungInha University HospitalRepublic of Korea

Kim, EunjungAllergan KoreaRepublic of Korea

Kim, EunkyungNovartisRepublic of Korea

Kim, EunyoungSamil Pharm. Co., Ltd.Republic of Korea

Kim, Go EunCelgene Corp.Republic of Korea

Kim, HannaC&R Research, Inc.Republic of Korea

Kim, HeehaKPMARepublic of Korea

Kim, HeejinLSK Global PSRepublic of Korea

Kim, HeeKyungSamsung ElectronicsRepublic of Korea

Kim, Ho SoonDongbu HannongRepublic of Korea

Kim, HongJooBerna Biotech Korea Corp.Republic of Korea

Kim, HyejinNovartis KoreaRepublic of Korea

Kim, HyesungSamil Pharm.Co.,Ltd.Republic of Korea

Kim, Hyun JinMSD KoreaRepublic of Korea

Kim, Hyung ShinLG Life ScienceRepublic of Korea

Kim, HyunjiWyeth KoreaRepublic of Korea

Kim, HyunJinInvida Korea LimitedRepublic of Korea

Kim, HyunjoSahmyook UniversityRepublic of Korea

Kim, In HyeKorea OIAA Co., LtdRepublic of Korea

Kim, In-BumKorean Research-based Pharmaceutical Industry Association (KRPIA)Republic of Korea

Kim, InhyangC&R Research, Inc.Republic of Korea

Kim, JaeWooAsan Medical CenterRepublic of Korea

Kim, JayoungGSKRepublic of Korea

Kim, JeeyoungKHIDIRepublic of Korea

Kim, Ji HyunMSD KoreaRepublic of Korea

Kim, JieunPfizerRepublic of Korea

Kim, JihyeUCB KoreaRepublic of Korea

Kim, Ji-HyunIlyang Pharmaceutical Co., Ltd.Republic of Korea

Kim, JisooSamyang CorporationRepublic of Korea

Kim, Ji-YeonGSKRepublic of Korea

partiCipants aLpHaBETIZED BY LaST NamE

11

Kim, JiyoonNovartis KoreaRepublic of Korea

Kim, Jong HagCKD BiO corp.Republic of Korea

Kim, KaeunBausch + LombRepublic of Korea

Kim, Kyong SunEisai Korea Inc.Republic of Korea

Kim, KyungsooGE HealthcareRepublic of Korea

Kim, MikyungAbbottRepublic of Korea

Kim, Min YoungPAREXEL Ltd.Republic of Korea

Kim, Min-YoungPfizer KoreaRepublic of Korea

Kim, MooSooSanofi PasteurRepublic of Korea

Kim, MyoungheeICON Clinical Research KoreaRepublic of Korea

Kim, NaEunBayerHealthCareRepublic of Korea

Kim, OkyoungNovartis KoreaRepublic of Korea

Kim, SabinMSD KoreaRepublic of Korea

Kim, Sam SikLG Life ScienceRepublic of Korea

Kim, Sei-EunHanmi Pharm. Co. Ltd.Republic of Korea

Kim, SeongHyeonJW PharmaceuticalRepublic of Korea

Kim, Seoyoungsanofi-aventis KoreaRepublic of Korea

Kim, Seung HeeNIFDSRepublic of Korea

Kim, ShinKeolLilly KoreaRepublic of Korea

Kim, SimonJeilkirinRepublic of Korea

Kim, Soo-KwanKolmar KoreaRepublic of Korea

Kim, SoyoungUCB KoreaRepublic of Korea

Kim, Sun AheLG Life Sciences, LtdRepublic of Korea

Kim, Sung HoGlaxoSmithKline KoreaRepublic of Korea

Kim, Sung IlLG Life Sciences, LtdRepublic of Korea

Kim, TaeeunRoche KoreaRepublic of Korea

Kim, Tae-GyunKFDARepublic of Korea

Kim, TaeHyunByaerhealthcareRepublic of Korea

Kim, WansooBoehringer Ingelheim Korea Ltd.Republic of Korea

Kim, YangheeC&C Research LabsRepublic of Korea

Kim, YeongjiChong Kun Dang Pharmaceutical Corp.Republic of Korea

Kim, YeRimBayer Korea LimitedRepublic of Korea

Kim, Yoon JeonMSD KoreaRepublic of Korea

Kim, YooniPRA KoreaRepublic of Korea

Kim, Youhwasanofi-aventis KoreaRepublic of Korea

Kim, Yun SunNovo Nordisk Pharma KoreaRepublic of Korea

Kim, YunhoC&R Research, Inc.Republic of Korea

Kim, ZisooQuintilesRepublic of Korea

Kiser, JohnAbbott LaboratoriesUnited States

Ko, SuyeonHarlanRepublic of Korea

Ko, YunjungSamjinRepublic of Korea

Kobayashi, KenJohnson & JohnsonJapan

Koh, A RaEisai Korea Inc.Republic of Korea

Kondo, ShujiPharmaceutical Research and Manufacturers of AmericaJapan

Koo, HyejinGSKRepublic of Korea

Koo, JihyunJeilkirinRepublic of Korea

Krause, RyokoIFPMASwitzerland

Kubic, ThomasPharmaceutical Security InstituteUnited States

Kukrety, ArvindGovernment of IndiaIndia

Kumagai, SusumuMitsui & Co., Ltd. Medical Healthcare Business DivisionJapan

Kustantinah, DraNational Agency for Food and Drug ControlIndonesia

Kwon, HyonsooKRPIARepublic of Korea

Kwon, InhyeNovartis KoreaRepublic of Korea

Kwong, Kwok Wai HestonDepartment of Health, HKSARGHong Kong

Kyounghee, SeoServier KoreaRepublic of Korea

Lebrilla, CrisostomoAmgenUnited States

Lee, AnnaHospital AuthorityHong Kong

Lee, AnnetteJohnson & JohnsonSingapore

Lee, Chang HeeGreen Cross Corp.Republic of Korea

Lee, Cho RongInternational StarcomRepublic of Korea

Lee, Choo AiHealth Sciences AuthoritySingapore

Lee, ChounhoDongchun Media Co.Republic of Korea

Lee, Do YounCJ CheilJedang Co.Republic of Korea

Lee, EunSunBaxter IncorporatedRepublic of Korea

Lee, HankyuGlaxoSmithKlineRepublic of Korea

Lee, Hwa-YoungPfizer Pharmaceuticals Korea Ltd.,Republic of Korea

Lee, Hye JungHopkins Bio Research Center, Inc.Republic of Korea

Lee, HyunaeBayer Korea Ltd.Republic of Korea

Lee, JaeWookGE Healthcare ASRepublic of Korea

Lee, JaewookPAREXELRepublic of Korea

Lee, JeeminLilly Korea LtdRepublic of Korea

Lee, Jeong SangSeoul National University Boramae HospitalRepublic of Korea

Lee, Jeong-AMerck Limited KoreaRepublic of Korea

partiCipants aLpHaBETIZED BY LaST NamE

12

Lee, Ji YeonAllergan KoreaRepublic of Korea

Lee, JiyeonSamil AllerganRepublic of Korea

Lee, JiYoungMSD KoreaRepublic of Korea

Lee, JooyunBayerRepublic of Korea

Lee, Ju HaKHIDIRepublic of Korea

Lee, Ju HyeonMSD KoreaRepublic of Korea

Lee, Jung EunGE Healthcare AS Korea BranchRepublic of Korea

Lee, Jung EunKoNECTRepublic of Korea

Lee, JungwonUCB KoreaRepublic of Korea

Lee, KyongjinMSDRepublic of Korea

Lee, Kyoung-ChunGSK KoreaRepublic of Korea

Lee, Kyung RimLilly KoreaRepublic of Korea

Lee, MihyunKorea Otsuka PharmaceuticalRepublic of Korea

Lee, MinahLundbeck KoreaRepublic of Korea

Lee, MiraLG Life SciencesRepublic of Korea

Lee, Na-YoungPharmaNet Korea LimitedRepublic of Korea

Lee, Ron-WaiAmgenUnited States

Lee, SeungdeokDongguk UniversityRepublic of Korea

Lee, SeunghunBayer HealthCare PharmaceuticalsRepublic of Korea

Lee, ShinwonPfizerRepublic of Korea

Lee, Si-NaeBMS KoreaRepublic of Korea

Lee, So RaNovoNordisk KoreaRepublic of Korea

Lee, So-JeongGlaxoSmithKlineRepublic of Korea

Lee, SophiaRoche KoreaRepublic of Korea

Lee, Sun HeeKFDARepublic of Korea

Lee, TaehyunMSD Korea Ltd.Republic of Korea

Lee, WilliamQuintiles East Asia Pte. Ltd.Singapore

Lee, Won-SikPfizer Pharmaceuticals Korea Ltd.Republic of Korea

Lee, Yeong MiKRPIARepublic of Korea

Lee, Yeong MiKRPIARepublic of Korea

Lee, Yeong-minPfizer KoreaRepublic of Korea

Lee, Yeonkyungsonofi-aventis KoreaRepublic of Korea

Lee, YoonYiAstellas Pharma Korea Inc.Republic of Korea

Lee, Young-sookBMS Pharmaceutical Korea Limited.Republic of Korea

Lee, YujinAbbott KoreaRepublic of Korea

Lee, YunkyungMSD KOREA LTD.Republic of Korea

Lertamphainont, NongnoothBristol-Myers Squibb Pharma Ltd. Thailand

Li, AndyPfizer Research & Development Co., LtdChina

Li, HuaUCBChina

Li, JingyiAstraZeneca China, Inc.China

Li, Xingsanofi-aventisChina

Li, XuesongLEO PharmaChina

Lim, ChristinaHealth Sciences AuthoritySingapore

Lim, Eun JiPfizerRepublic of Korea

Lim, JI-SunYonsei UniversityRepublic of Korea

Lim, JohnHealth Sciences AuthoritySingapore

Lim, JonathanKHIDIRepublic of Korea

Lim, JunghyunSanten KoreaRepublic of Korea

Lim, Min-JungGSK KoreaRepublic of Korea

Lim, YunniRoche KoreaRepublic of Korea

Lim, Hyun ChulDasan Medichem Co., Ltd.Republic of Korea

Lin, YangSingapore RadiopharmaceuticalsSingapore

Lin, Yu-JuAstellas Pharma Taiwan, Inc.Taiwan

Lo, Man WahGenzymeHong Kong

Lo, ShirleyJanssen Cilag Asia PacificSingapore

Low, Chee KimGlaxoSmithKline Pte LtdSingapore

Lu, YuzhenShanghai Roche Pharmaceuticals Ltd.China

Ma, HelenaBeijing Novartis Pharma Ltd.China

Maeda, AkioAbbott Japan Co., Ltd.Japan

Maryati, HerlysGlaxo Wellcome IndonesiaIndonesia

Masuda, KojiChugai ChinaChina

Meng, QianRoche Product Development in Asia PacificChina

Miki, SatoshiUCB Japan Co., Ltd.Japan

Min, Hyang Won (Harriet)UCB Korea LtdRepublic of Korea

Miok, SongDasan MedichemRepublic of Korea

Mishra, ArunGlaxoSmithKlineUnited Kingdom

Miyazawa, SeijiJPMAJapan

Miyeop, LeeCJ CheilJedang CorporationRepublic of Korea

Moah, SonJW PharmaceuticalRepublic of Korea

Molzon, JustinaCenter for Drug Evaluation and Research/ USFDAUnited States

Monk, DeborahMedicines AustraliaAustralia

Moon, NoomiKRPIARepublic of Korea

partiCipants aLpHaBETIZED BY LaST NamE

13

Morénas, JacquesThe French Health Products Safety Agency (AFSSAPS)France

Morin, OdetteIFPMASwitzerland

Mozzicato, PatriciaMedDRA MSSOUnited States

Mulholland, LeynaF Hoffman-La RocheJapan

Mune, JuneSikBaxterRepublic of Korea

Murao, NoriakiMerz Pharmaceuticals GmbHJapan

Music, TamaraIFPMASwitzerland

Myint, Thiri TunFood and Drug Administration, Ministry of Health, Myanmar

Nakamura, HidefumiNational Center for Child Health and Development IndustryJapan

Nam, HyukjunMEDIPOST Co., Ltd.Republic of Korea

Nam, KyuyeolKorea United Pharm. Inc.Republic of Korea

Nam, MoonsukINHA University HospitalRepublic of Korea

Nam Gung, SukADM KoreaRepublic of Korea

Namgung, Yun JungRoche Korea Co., Ltd.Republic of Korea

Nasr, MohebFood and Drug Administration United States

Noda, KouichiMochida Pharmaceutical Co. Ltd.Japan

Noh, HeejungBaxterRepublic of Korea

Noh, Yun HongKFDARepublic of Korea

Oh, Ji YoungQuintiles KoreaRepublic of Korea

Oh, JoungwonKorea Food and Drug Administration (KFDA)Republic of Korea

Oh, Kyu-HoLSK Global Pharma ServicesRepublic of Korea

Oh, Sae WonEli LillyRepublic of Korea

Okayasu, AyakoAstrazeneca KKJapan

Okuda, TeruyoshiNiphix KKJapan

Ono, TeruakiC&C Research LaboratoriesKorea (DPR)

Ono, YoshihikoPfizer Japan Inc.Japan

Pang, Ka Yan AdaFresenius Kabi Asia PacificHong Kong

Park, Alex KyunghwaAllergan KoreaRepublic of Korea

Park, BeomsooDong-A Pharmaceutical Co. LtdRepublic of Korea

Park, BojungSanten KoreaRepublic of Korea

Park, Byung-JuRepublic of Korea

Park, Chae YoungJohnson and Johnson Medical KoreaRepublic of Korea

Park, Chang-WonFood and Drug AdministrationRepublic of Korea

Park, Gang YongKHIDIRepublic of Korea

Park, Hee YoungKFDARepublic of Korea

Park, Hwan GukKHIDIRepublic of Korea

Park, Hye JungCJ Cheiljedang Corp.Republic of Korea

Park, HyeYoungCELLTRION,IncRepublic of Korea

Park, Hyo EunLG Life ScienceRepublic of Korea

Park, HyonamMerck KoreaRepublic of Korea

Park, HyunJuAbbott KoreaRepublic of Korea

Park, Jae EunBaxterRepublic of Korea

Park, Jae YounJW Holdings/Global Business DivisionRepublic of Korea

Park, Jin-YoungGSKRepublic of Korea

Park, JoanKHIDIRepublic of Korea

Park, JongeunMSDRepublic of Korea

Park, JungheeMSD Korea LTDRepublic of Korea

Park, Kui LeaKorea Food and Drug Administration (KFDA)Republic of Korea

Park, KyehyunKRPIARepublic of Korea

Park, Mi SukKorea UCB Co., LTDRepublic of Korea

Park, Min SooYonsei UniversityRepublic of Korea

Park, MyungHaGSKRepublic of Korea

Park, Neunggyu(Paul)CMIC KOREARepublic of Korea

Park, Sang MiActelionRepublic of Korea

Park, SangminC & R ResearchRepublic of Korea

Park, SeJinC&C Clinical LabRepublic of Korea

Park, ShinmyunCelltrion, Inc.Republic of Korea

Park, Shin-youngKorea Institute of ToxicologyRepublic of Korea

Park, So-YeonCelgene KoreaRepublic of Korea

Park, SoyoungBayer Korea LtdRepublic of Korea

Park, YumiJW HoldginsRepublic of Korea

Peiravian, FarzadQazvin University of Medical SciencesIran

Picker, Jean-lucServierRepublic of Korea

Poh, JaleneHealth Sciences AuthoritySingapore

Pradhan, AKGovernment of IndiaIndia

Qiu, YihongAbbott LaboratoriesUnited States

Quoc Cuong, TruongDrug Administration of VietNam, Ministry of Health, Vietnam

Rägo, LembitWHOSwitzerland

Rahman, Eishah A.Ministry of HealthMalaysia

Ramirez, CinthyaIFPMASwitzerland

Ramkishan, AjmeerCDSCO, Government of IndiaIndia

Rau, IreneGlaxoSmithKlineTaiwan

partiCipants aLpHaBETIZED BY LaST NamE

14

Remaut, Anne-CécileScience UnionFrance

Ren, JanniePfizer (China) Research & Development Co., LtdChina

Rhee, JiwonOtsuka International Asia ArabRepublic of Korea

Rhee, Soo-JinPPDRepublic of Korea

Rhim, Hyou YoungJanssen KoreaRepublic of Korea

Richardson, PeterEuropean Medicines Agency (EMA)United Kingdom

Robinson, Lisa TKellen MeetingsUnited States

Roh, SeungahCJ CheilJedang Corp.Republic of Korea

Roongadulpisan, PintipThai Meiji Pharmaceutical Co., Ltd.Thailand

Routhier, François-Xaviersanofi-aventis R&DFrance

Rozycki, MichaelBayerChina

Ruiz de Erenchun, FerminHoffmann-La Roche LtdSwitzerland

Sang Cheol, ShinGreen CrossRepublic of Korea

Santoso, LuciaExperimental Therapeutics CentreSingapore

Seerangam, Selvaraja S.National Pharmaceutical Control Bureau, Ministry of Health Malaysia

Sengaloundeth, SivongFood and Drug Department, Ministry of Health, Lao PDRLao PDR

Seo, JeongeunMSD KoreaRepublic of Korea

Seo, KwangSeokDong-A PharmaceuticalRepublic of Korea

Seob-Lee, YilGlaxoSmithKlineRepublic of Korea

Seol, Choon KeunCKD Bio CorporationRepublic of Korea

Seol, JaeyoonNovartis Korea Ltd.Republic of Korea

Seong, YoonjuBoehringer Ingelheim Korea Ltd.Republic of Korea

Shen, YanyunRoche ChinaChina

Shim, Jae MyungCelgene KoreaRepublic of Korea

Shim, JuyounKorea OIAA,Republic of Korea

Shim, SoyounGenzyme KoreaRepublic of Korea

Shimizu, YokoTakeda Pharmaceutical Company LimitedJapan

Shin, Dong YeopLG Life Science,Ltd.Republic of Korea

Shin, Dong-HoonKeimyung University Dongsan Medical CenterRepublic of Korea

Shin, EunjeongWyeth KoreaRepublic of Korea

Shin, HeekangBayer KoreaRepublic of Korea

Shin, MihyeInnopath Intl. Inc.Republic of Korea

Shin, Sang GooKoNECTRepublic of Korea

Shin, Sang MinLG Life SciencesRepublic of Korea

Shin, Sang-GooSeoul National University College of Medicine and HospitalRepublic of Korea

Shin, ZisoonNovo Nordisk Pharma Korea. Ltd.Republic of Korea

Shinozuka, HideoKyowa Hakko Kirin Co.,LtdJapan

Sia, Kin TongLEO Pharma Asia Pte LtdSingapore

Simanjuntak, ParulianInternationa Pharmaceutical Manufacturers Group (IPMG)Indonesia

Singh, RomiAmgenUnited States

Slamet, M.Sc, Lucky S.National Agency for Drug and Food ControlIndonesia

Sohn, Ji YeonAstellas KoreaRepublic of Korea

Sohn, Kyu BeenPfizerRepublic of Korea

Son, KyunghwaIsuabxisRepublic of Korea

Song, RokGlaxoSmithKlineRepublic of Korea

Song, Sang YupNovoNordisk KoreaRepublic of Korea

Song, SoohyeonKorea OIAARepublic of Korea

Song, Yurn-SuBoehringer-Ingelheim KoreaRepublic of Korea

Soo Kiang, CheahPharmaNet Pte LtdSingapore

Soon, Swee SungSingapore Clinical Research InstituteSingapore

Suh, BrianKHIDIRepublic of KoreaSuh, InhooNovotech Asia KoreaRepublic of Korea

Suh, SeungwonISU ABXIS CO.,LTDRepublic of Korea

Suk, Hwa OkSarangmal International VolunteerRepublic of Korea

Sumi, LeeDongwha Pharm.Republic of Korea

Sun, PengAstraZeneca Pharmaceutical Co.,Ltd.China

Sung, Hye-youngAsan Medical CenterRepublic of Korea

SungMo, KangDasan Medichem Co., Ltd.Republic of Korea

Tacandong, NazaritaFood and Drug AdministrationPhilippines

Takaki, KojiChugai Pharmaceutical Co., Ltd.Japan

Tan, AdelineAllergan Singapore Pte LtdSingapore

Tan, EmilyPharmaNet Pte LtdSingapore

Tanaka, RihoMitsui & Co., Ltd. Medical Healthcare Business DivisionJapan

Tay, Kee WeeAbbott Laboratories (Singapore) Pte LtdSingapore

Temeck, JeanFood and Drug Administration United States

Thompson, ElizabethBayer Australia Ltd.Australia

Totsuka, HitoshiUCB Japan Co.,Ltd.Japan

Tsay, RickMSD JapanJapan

Tseng, EricServierTaiwanTsim, ClariceFresenius Kabi Asia Pacific LtdHong Kong

Tsuchiya, EtsukoEisai Co., Ltd.,Japan

Uditananda, MalineeDKSH LimitedThailand

partiCipants aLpHaBETIZED BY LaST NamE

15

Uditananda, PrimBaker & McKenzie Ltd.Thailand

Usavakidviree, VinitFood and Drug Administration, Ministry of HealthThailand

Uyama, YoshiakiPharmaceuticals & Medical Devices AgencyJapan

Uzu, ShinobuMinistry of Health, Labor, and Welfare (MHLW)Japan

Vermeulen, AnJanssen Research & DevelopmentBelgium

Walker, MichaelIFPMASwitzerland

Walker, MichaelIFPMASwitzerland

Wang, Chao-YiTaiwan Food and Drug AdministrationTaiwan

Wang, Chien-ChiaGlaxoSmithKlineTaiwan

Wang, FanrongHangzhou MSD Pharmaceutical Co., Ltd. Beijing BranchChina

Wang, JaneShanghai Roche Pharmaceuticals Ltd.China

Wang, JiahongAbbott LaboratoriesUnited States

Wang, NaShanghai Roche Pharmaceuticals Ltd.China

Wang, RebeccaShanghai Roche Pharmaceuticals LtdChinaWang, YingboDaiichi Sankyo Pharmaceutical (Beijing) Co., Ltd.China

Ward, MikeHealth CanadaCanada

Waterson, AdrianAstraZenecaUnited Kingdom

Wei, ZhangSFDAChina

Wijaya, EllenGlaxo Wellcome IndonesiaIndonesia

Wong, FarahCSL Biotherapies Asia PacificHong Kong

Wong, Kum CheunJohnson & Johnson Pte LtdSingapore

Wong, Wai WaiDepartment of Health, HKSARGChina

Woo, LindaDepartment of Health, HKSARGHong Kong

Woo-hyuk, ChangPharmAsia News/Elsevier Business IntelligenceRepublic of Korea

Woo-Jong, SonCreageneRepublic of Korea

Woonhyuk, ChoiLSK Global PSRepublic of Korea

Wu, LeiUCBChina

Yagn, Hyun JooHandok Pharmaceuticals Co., Ltd.Republic of Korea

Yahagi, YuichiASKLEP Inc.Japan

Yang, BrianPAREXEL InternationalTaiwan

Yang, HyunjuDaiichisankyoRepublic of Korea

Yang, JoohaKRPIARepublic of Korea

Yang, JyunyanEli Lilly and CompanyTaiwan

Yang, TinaAstraZenecaTaiwan

Yang, You KyungKPMARepublic of Korea

Yasunaga, KazumichiAstellas Pharma Inc.Japan

Yeobin, YunC&C Research Labs.Republic of Korea

Yi, JungyoungGE HealthcareRepublic of Korea

Yim, SusannaJohnson & Johnson Ltd.Hong Kong

Yim, YoungwonKorea Otsuka Pharmaceutical Co., LtdRepublic of Korea

Yong, KimIksu Pharmaceutical Co., LtdRepublic of Korea

Yoo, Hye JongAstraZenecaRepublic of Korea

Yoo, JinhoM-CESRepublic of Korea

Yoo, Kyung JinWyeth KoreaRepublic of Korea

Yoo, So YoungKorea OIAA Co., Ltd.Republic of Korea

Yoo, YonghaeAllerganRepublic of Korea

Yoon, ByungInC&R Research, Inc.Republic of Korea

Yoon, HyeyoungNovartis KoreaRepublic of Korea

Yoon, JeongsookIldong Pharmaceutical Co., LtdRepublic of Korea

Yoon, SangyeeSamil Pharm.Co.,Ltd.Republic of Korea

Yoon, SogyemBMS KoreaRepublic of Korea

Yoshida, HiroshiMitsubishi Tanabe Pharma CorporationJapan

Youn, HaecheolYonsei University Dental HospitalRepublic of Korea

Yu, Eunyoung SarahPRA KoreaRepublic of Korea

Yu, Yeo-JinGlaxoSmithKlineRepublic of Korea

Yuk, YeoJoosanofi-aventis KoreaRepublic of Korea

Yun, Hye JungJW PharmaceuticalsRepublic of Korea

Yun, Ji HoonBerna Biotech Korea Corp.Republic of Korea

Yun, Ji-SukFresenius Kabi Korea Ltd.Republic of Korea

Zhang, FanJohnson & JohnsonSingapore

Zhang, HonggangLEO Pharma ChinaChina

Zhang, HuaPfizer ChinaChina

As of April 15, 2011

partiCipants aLpHaBETIZED BY LaST NamE

16

Main Hotel 2 Fl.

•S i z e o f bo o th : 3M( W ) X 2M( L )

•C a pa bi l i ty o f G r a n d ba l l r oo m fo y e r :

20 bo o th s i n to ta l

•N e c e s s i ti e s fo r bo o th c o n tr a c to r : F l oo r pr o te c to r ( fa br i c ) , E x te n s i on c o r d

• P o we r : l e s s th a n 2K W pe r bo o th

( i f m o r e th a n 2 K W /bo o th n e e ds , p l e a s e d i s c u s s i n a dv a n c e )

5

6

3

4 2

1

C offee

S peaker ready room

Parallel track

VIP R OOM

Plenary S es s ion

floorplan

Asia Regulatory Conference:Asia’s Role in Global Drug Development

April 26-28, 2011Grand Hilton Hotel, Seoul, Republic of KoreaMain Hotel • 2nd Floor Plan

Presented by

eXhiBitor list

Zuellig Pharma Specialty Solutions Group

Zuellig Pharma Specialty Solutions Group (SSG) is the pioneering regional consultancy and bio-logistic services division of Zuellig Pharma Asia Pacific, Asia’s leading pharmaceutical and healthcare distribution company. SSG leverages Zuellig Pharma’s cutting-edge pan-Asian infrastructure to provide customized, valued added bio-logistic solutions for pharmaceutical, clinical trials, medical device, diagnostics and other related companies.

Clinical Reach Leveraging experience, reaching furtherSSG’s Clinical Reach comprises of a network in Asia that spans over 14 depots in 13 countries. SSG provides integrated end-to-end supply chain support for over 800 trials and specializes in storage and distribution of Investigational Drugs used in Phase I through Phase IV open labeled, blinded or randomized clinical studies. Our SOPs and facilities conform with global quality standards (GMP, GCP, GSDP, ISO9000)

Anti-Counterfeit SolutionReal-time IntelligenceSSG has developed an anti-counterfeiting solution - ZiP CHECK which combines both serialisation and SMS technologies. The key to

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ZiP CHECK enables a product to be tracked from the point of serialisation. It is designed to create an ongoing product history whenever the product is checked within the supply chain from distribution through to the retail outlet. SMS and web-based enabled features allow product authentication, consumer enpowerment

and brand enhancement.

Zuellig PharmaSpecialty Solutions Group Pte LtdTel: +65 6546 8188Fax: +65 6546 8288enquiry@zuelligpharma.comhttp://www.zuelligpharma.com/ssg

Connect with us to connect with Asia

Zuellig Pharma Korea

Tel: +82 (02) 2006-0600Fax: +82 (02) 2006-0650

krcontacts@zuelligpharma.com

Core Services

• Value creation through network consultancy• Secondary labeling and repackaging of IP• Secured and confidential storage• Regulatory Assistance• Kit-building of lab supplies• Biological specimens shipment• Transport management

Value-added Services

• Cold chain handling and validated shipper boxes• Returns & Destruction services• IVRS and IWRS updating• Comparator and ancillary supplies sourcing

18presenters BioGraphies aLpHaBETIZED BY LaST NamE

Ms. Ruth Lee Choo Ai is the Director for the Enforcement Branch in Health Sciences Authority, the National Drug Regulator in Singapore. She has a MBA degree from the Monash University (Australia) and a BSc (Pharmacy)(Honours)(1986) from the National University of Singapore.

In 2004, she joined the Enforcement Branch at the Health Sciences as the Deputy Head(Investigation) and rose to the rank of Director in Jan 2011.

She has been a practicing pharmacist for close to 17 years in various capacities such as retail, hospital pharmacist, regulatory affairs manager, to Operations Manager in charge of a Medical Centre. She has been a member of the Pharmaceutical Society of Singapore since 1986.

In November 2006, she was nominated as one of the Vice-Chairs for the WHO International Medical Products Anti-Counterfeiting Taskforce (IMPACT) Planning Group during the Bonn(Germany) meeting and since then she has been actively involved in the organization and implementation of the various regional and international initiatives and projects, in her capacity as the Vice Chair.

Dr. Yuki Ando, MSc. is currently Principal Reviewer for Biostatistics, Office of New Drug II, Pharmaceuticals and Medical Devices Agency (PMDA). She received a master’s degree in engineering from Tokyo Science University in 1997, and joined the Pharmaceuticals and Medical Devices Evaluation Center, which was subsequently transformed into the current PMDA. Her experience as a statistical reviewer at the Japanese regulatory body is almost 14 years. She is a leader of the Biostatistics Group and she is involved in the trial design training course for statisticians and non-statisticians in PMDA in addition to reviewing new drugs.

Dr. André Broekmans, PhD is currently Vice President Most of World Regulatory Policy & Regulatory Affairs with MSD and located in Oss, the Netherlands.

He joined pharmaceutical industry in 2001 and held different senior positions in regulatory affairs within Organon respectively Schering Plough until the company was officially acquired by MSD in November 2009.

André has practiced as a general internist at the Leiden University Hospital where he also did his PhD in thrombosis research. After a career with the Netherlands Heart Foundation as head of Medical Affairs he joined the Medicines Evaluation Board in the Netherlands. The first years he was head of the Clinical Assessment Department and later the Chief Executive of the Agency. He served at the Management Board of the European Medicines Agency, in his last year as chairman of the Board. Early 2000 he was Professor of Pharmaceutical Technology Assessment at the Utrecht University, the Netherlands.

André is member of the Scientific, Regulatory and Manufacturing Policy Committee (SRMPC) of EFPIA, the Regulatory Policy and Technical Standards Committee (RPTS) of IFPMA. On behalf of EFPIA he is member of the Steering Committee of the International Conference on Harmonization (ICH) and the Global Cooperation Group (GCG).

Ms. Agnes Chan was trained as a pharmacist and has worked at the Health Sciences Authority (HSA) of Singapore since 2001. She started as a clinical reviewer and her current career focuses on medicines regulations and regulatory policies. As a regulatory consultant, Agnes played a key role in the legislative review of health products laws as well as the development of regulatory frameworks in Singapore. She is also actively involved in regional harmonization initiatives in particular the ASEAN Pharmaceutical Products Working Group and in international collaborative programmes on regulatory development, including the WHO Paediatric Medicines Regulators’ Network.

Ms. Jennifer Chen joined the R&D-based Pharmaceutical Association Committee as Director of Legal Affairs in February 2006. Her responsibilities at RDPAC cover the intellectual property-related issues for the pharmaceutical Industry, as well as compliance initiatives in connection with the RDPAC Code of Practice on the Promotion of Pharmaceutical Products.

Before joining RDPAC, Jennifer worked for more than 10 years as a legal practitioner with both Chinese and international law firms, specialized in foreign direct investment, intellectual property rights, and other commercial as well as policy-related issues representing major multinational investments in China. She also worked as the acting legal director for Pfizer China from early 2004 through the end of 2005, where she started to focus her professional interest in the pharmaceutical Industry.

Jennifer Chen earned a PhD in Law and a Master in Law from Renmin University Law School (Beijing, China), and an LLM from the George Washington University Law School. She was admitted to the Chinese Bar in 1996 and the New York State Bar Association in 2002.

Dr. Herng-Der Chern, PhD degree from National Taiwan University in 1983 and his Ph.D. degree in pharmacology from University of Pittsburgh in 1994. Before he joined Center for Drug Evaluation in 1998, Dr. Chern was the head of Division of Clinical Pharmacology of National Taiwan University Hospital and associate professor in National Taiwan University. Until March 2011, Dr. Chern had been the Executive Director of Center for Drug Evaluation and in charge of technical review of IND/NDA/HTA for Taiwan’s government. Under his leadership, Center for Drug Evaluation is one of a few regulatory agencies in Asia that can perform in-house review based on good regulatory science.

In the last 12 years, Dr. Chern plays a very active role in promoting ICH concept, GCP education, good review practice, bridging study, new drug development and Health Technology Assessment in Asia. Dr. Chern served as the APEC representative for the ICH-GCG group in ICH 5 and ICH 6.

Dr. Chern involved in many regional harmonization initiatives especially the APEC Network of Pharmaceutical Regulatory Science leaded by Taiwan since 2000 and APEC Best Regulatory Practice Project since 2011. Not only serving as a speaker and session chair in many DIA conferences, Dr. Chern was also the guest editor for four issues, focused on the current status of infrastructure and regulatory science of new drug development in Asia, for Drug Information Journal in 1998, 2003 and 2009. Dr. Chern is the winner of 2006 DIA Outstanding Service Award for his contribution to DIA.

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Dr. Sannie Chong SF obtained her Bachelor (Honours) Degree in Chemistry, majoring in Bio-organic Chemistry and Toxicology. PhD research in drug design and drug delivery systems had also taken her to universities in the UK and the US.

She is currently the Director of the Generics & Biosimilars Branch as she oversees the registration of generics and biosimilars in a timely fashion in order to ensure efficient use of high-quality and safe medicine. On the regional and international front, Dr. Chong represents Singapore and HSA in the Technical Working Group of the ASEAN Consultative Committee for Standards & Quality (ACCSQ) as Chair of Process Validation as well as Co-Chair of ASEAN Variation Guidelines. She also assists the World Health Organization (WHO) in product assessment as part of the WHO prequalification of medicines program.

Mr. Alistair DavidsonSenior Director, Regulatory Affairs, Asia-Pacific, PPD, Cambridge, England (from April 2011).

Previous positions:• Senior Director, Global Regulatory Affairs, Quintiles Transnational, Bracknell, England (2010-2011).

• Vice-President, International Regulatory Affairs, GlaxoSmithKline, Greenford, England (2006-2010).

• Director, Worldwide Vaccines Registration, GlaxoSmithKline Biologicals, Rixensart, Belgium (2003- 2006).

• Vice-President & Regulatory Director, GlaxoSmithKline Asia-Pacific, Singapore, (2000 - 2003).

• Regional Regulatory Director, Asia, SmithKline Beecham, Singapore (1997 -2000).

• Regional Regulatory Manager, SmithKline Beecham International, Brentford, England, (1991 – 1997).

• Wellcome Environmental Health: Product Registration, Berkhamsted, England, (1988 – 1991).

• Norbrook Laboratories Ltd: Regulatory Affairs, Newry, N Ireland, (1985 – 1988).

Experience:• Leading strategic regulatory role over many years for the high-growth Emerging Markets and Asia-Pacific

• Significant international exposure and in-depth M&A experience. • Global regulatory experience at the headquarters of the world’s leading vaccine company, during a period of major innovation and expansion.

• Leading regulatory teams across different cultures, functions and roles.

• Extensive direct experience and responsibilities for regulatory activities in Europe, Asia (including India and China), Middle East countries (including Turkey and Pakistan), Latin America (including Brazil and Mexico) and Africa.

• Previous Industry roles include experience as Chair of EFPIA’s (European Federation of Pharmaceutical Industries and Associations) International Regulatory Affairs Group, and as a member of IFPMA’s (International Federation of Pharmaceutical Manufacturers and Associations) Regulatory Policy and Technical Standards Committee.

• Organised and led the first two face-to-face conferences involving Industry and Middle East regulatory agencies (1996 and 1997), now organised by DIA; chaired Organising Committee for IFPMA’s 2008 Asia Regulatory Conference.

Ms. Weon DoEducation:Seoul National University, Master of Pharmacology, Feb. 1986Seoul National University, Bachelor of Pharmacy, Feb. 1984

Professional Experience:• Sanofi Aventis Korea • Head of Regulatory Affairs and Market Access

Social Experience:• Chair of Regulatory Committee in KRPIA • Cochair of Regulatory Committee in KRIPA

Dr. Paul R. Eisenberg, M.P.H., F.A.C.P., F.A.C.C. is the Senior Vice President of Global Regulatory Affairs and Safety at Amgen, effective February 2008. He was promoted after serving as Vice President of Global Regulatory Affairs and Safety since January 2007, and Vice President of Global Safety since December 2005.

Prior to joining Amgen, Dr. Eisenberg was the Vice President of Lilly Global Product Safety. At Lilly he also led Clinical Development teams in Cardiovascular, Critical Care, and Inflammation Therapeutic Areas as Vice President - Internal Medicine and in discovery as Executive Director of Cardiovascular Research and Clinical Investigation.

Dr. Eisenberg received his M.D. from New York Medical College and M.P.H. in Tropical Medicine from Tulane University School of Public Health. He was a Professor of Medicine at Washington University in St. Louis where his academic career, over 18 years, was focused on basic and clinical research in cardiovascular disease and thrombosis. This work led to over 100 publications in peer-reviewed journals and books. He has been involved in the discovery and development of numerous new molecular entities in both his academic and industry career.

Dr. Eisenberg has led the development and registration of multiple NMEs in cardiovascular and critical care. In addition, he has extensive experience in global safety and risk management programs for drug development programs and post-marketing in multiple therapeutic classes.

In his current role, Dr. Eisenberg has also led teams in filing multiple marketing authorization applications globally of novel biopharmaceuticals in hematology, endocrine and inflammation therapeutic areas. He leads teams responsible for the global regulatory strategies in oncology, nephrology, inflammation, metabolic and cardiovascular disease therapeutic areas. In addition to leading the global regulatory and safety organization at Amgen, he has represented Amgen and industry in global and FDA regulatory meetings, scientific forums and molecule-specific forums related to drug development.

Dr. Fermin Ruiz de Erenchun, PhD, is a board certified dermatologist with more than 16 years of pharmaceutical industry. During his career, he has work in local, regional and global medical affairs functions in the area of inflammation and oncology. He has also developed a broad experience in clinical development and life cycle management in global roles and during 2 years, he was general Manager at Roche Peru in Lima. Now he is leading special regulatory affairs projects at Hoffmann La Roche in Basel and is the head of the biotherapeutic working group at IFPMA.

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Dr. Georges FranceTitle: Vice President Global Quality Strategy & IAQC (International Affiliate Quality Compliance), PFIZER, Based In Maidenhead UK

Summary: Georges started working in a general hospital as a biologist and following this held QP/Pharma responsibilities for 15 years in France in small, middle sized (FISONS) and large Pharma companies (Schering Plough and Wyeth in 96). In 2005 he moved to the UK for Wyeth and lead the Quality organisation for the EMEA Region Europe, Middle East & Africa as VP. He took his new role when Pfizer acquired Wyeth.

Regarding external responsibilities, for EFPIA, he is Topic Leader for ICH Q-IWG (Quality Implementation Working Group), previously for Q10 and for IFPMA he is quality representative for RPTS (Regulatory Policy and Technical Standard)

Georges is a Doctor of Pharmacy, post graduate degree in Pharmacology, Production Management & INSEAD Business School. He is member of French Academy of Pharmacy.

Dr. Yukio Hiyama, PhD, is Visiting Scientist at National Institute of Health Sciences. He received Ph.D. degree in Chemistry from the University of Tokyo in 1979. He leads MHLW’s study groups to draft GMP related guidance and to propose the regulatory framework under the revised Pharmaceutical Affairs Law. He led an industry-government Human Science project on evaluation methods for pharmaceutical development and manufacturing control. He is a member of Pharmaceutical and Food Council and co-chair of JP Chemical Monograph Committee. He has been involved in the ICH discussion for Q8, Q9 and Q10. He is the topic leader for Q9 and Q10 for MHLW. His previous work experiences include positions in Pharmaceutical Development in Upjohn Co. in US and in Japan, scientist at National Institutes of Health, USA and post-doctoral fellow at University Illinois.

Dr. In-Jin Jang, PhD, is Professor of Department of Pharmacology, Seoul National University College of Medicine and Director of Department of Clinical Pharmacology, Seoul National University Hospital.

He obtained degrees of M.D. and PhD in 1987 and 1992 at Seoul National University, College of Medicine. He is a clinical pharmacologist who majors in pharmacogenomics, population PK/PD modeling, simulation of clinical trial and early clinical drug development methodologies. He worked as a visiting research fellow at Center for Drug Development Science, Georgetown University Medical Center from 1998 to 2000, where he was involve in population PK/PD modeling and simulation of clinical trial. At Seoul National University and Hospital, he is responsible for research and education in the field of clinical pharmacology, especially pharmacogenomics and PK/PD. He is in charge of therapeutic drug monitoring consultation and execution of phase 1 clinical trials at Clinical Trials Center as a director of Department of Clinical Pharmacology and Therapeutics at Seoul National University Hospital.

Dr. Yves Juillet is a specialist in internal medicine, cardiology and pharmacology, and is at present Senior Advisor to LEEM (the Association of Pharmaceutical Industries in France ).

Prior to this appointment he was Director of Public Affairs of Aventis , Director of Pharmaceutical and Public Affairs of Hoechst Marion Roussel, Inspector General of Roussel Uclaf, Vice President

for Licensing, Medical and Regulatory Affairs of the Jouveinal Group, Deputy Managing Director and Director of Scientific and Technical Affairs of SNIP (French Manufacturers Association) and Department Head at the Broussais Hospital in Paris.

For seven years Dr Juillet was a Member of the official Registration Committee (AMM), Transparency and Post Marketing Committees of the French Health Ministry, where he represented Industry. He was also a member of the Board and the Executive Board of the Pharmaceutical Industry Association in France.

He was Chair of the EFPIA Scientific Technical and Regulatory Policy Committee for 10 years . He was a Member of the ICH Steering Committee and Co-Chair of the ICH GCG. He is the Chairman of the IFPMA Regulatory Policy and Technical Standards CommitteeHe is a Member of the French Académie Nationale de Pharmacie and corresp Member of the Académie de Médecine.

He is President Elect of the Drug Information Association (DIA)

Dr. Megan Keaney, Principal Medical Adviser, Therapeutics Goods Administration

Dr Megan Keaney was appointed Principal Medical Adviser of the Therapeutic Goods Administration (TGA) in February 2011. She joined TGA from the Commonwealth Department of Health and Ageing where, most recently, she was acting head of the Diagnostic Services Branch in the Medical Benefits Division responsible for policy development and implementation that ensured access for all Australians to high quality pathology and diagnostic imaging services.

Before joining the department in late 2009, Dr Keaney held senior positions at Avant Australia’s largest medical indemnity organisation. Over her 18 year career in medical indemnity she headed up Avant’s claims department and directly managed most of Avant and its predecessor organisation’s major claims. She frequently presented to medical conferences on medical adverse events, claims and risk management topics

Until December 2009 Dr Keaney was Chair of the Board of the National Breast & Ovarian Cancer Centre and a member of the Advisory Council of Cancer Australia, which are Australia’s two Commonwealth government funded cancer control agencies.

Dr Keaney graduated in 1981 and her clinical background is in Accident and Emergency and she continues to work periodically in the Emergency Department of Alice Springs Hospital. Alice Springs is situated in Central Australia and is the regional medical centre for indigenous Australians who live in remote communities.

Dr Keaney has taken over the position of Principal Medical Adviser from Dr Ruth Lopert who has taken up the role of Visiting Professor in Health Policy at George Washington University, Washington DC.

Dr. Susanne Keitel is a licensed pharmacist with a Ph.D. in pharmaceutical technology. Her work experience includes 10 years in pharmaceutical development in industry, with five years as Department Head of ”Pharmaceutical Development/Oral Dosage Forms“ at the former Schering AG, Berlin. From 1997 to 2005, she held the position of Division Head Pharmaceutical Quality at the Federal Institute for Drugs and Medical Devices (BfArM), Germany. She additionally served as Acting Head of the Division European Procedures from November 2003.

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From July 2005 to October 2007, Susanne Keitel was Head of EU, International Affairs at BfArM. During her time with BfArM, she represented the agency in a number of EU committees, including the Joint CHMP/CVMP Quality Working Party (QWP), the EMEA Paediatric Working Party and the European Commission’s Notice to Applicants Group. She was actively involved in the International Conference on Harmonization (ICH), where she acted as the EU topic leader and rapporteur for the ICH guidelines on stability testing and pharmaceutical development. On a national level, she was, from 2001 to 2007, Chair of the German Pharmacopoeia and the German Homeopathic Pharmacopoeia. Since October 2007, Susanne Keitel is Director of the European Directorate for the Quality of Medicine & HealthCare (EDQM) of the Council of Europe in Strasbourg.

She also lectures in the postgraduate course “Master of Drug Regulatory Affairs” at Bonn University, where she is responsible for the module on the quality dossier. In 2009, Dr. Keitel was elected as corresponding Foreign Member at the French Académie Nationale de Pharmacie.

Mr. John Kiser is Sr. Director, Global Submission Operations at Abbott Laboratories with over 20 years experience in the Life Science area and 14 years in regulatory operations focusing on drug submissions to regulatory agencies. Active member of industry trade associations PhRMA (US) and EFPIA (EU) as well as the Standards Development Organization HL7 in the support of progressing standards for electronic exchange of information. Education includes a Bachelor of Science in Computer Science from Bowling Green State University and a Masters in Quality & Regulatory Science from Northwestern University.

Mr. Thomas T. Kubic, President & CEO Pharmaceutical Security Institute

Tom Kubic is a former Deputy Assistant Director of the FBI with national and international investigative experience.

Working closely with a new Pharmaceutical Security Institute’s twenty-four members to insure the integrity of pharmaceuticals and, most importantly, to protect public health, he was selected as the President & CEO in October 2008. Under his leadership, PSI has been completely reorganized to emphasize information sharing and private-public sector cooperation.

Mr. Kubic represents the Institute at numerous international meetings, conferences and seminars. He has provided testimony concerning the international nature of counterfeiting and its devastating impact before senior government officials around the world. He currently serves as an officer with the Partnership for Safe Medicines, and as an advisor to the Permanent Forum on International Pharmaceutical Crime and Interpol’s Medical Products Counterfeiting and Pharmaceutical Crime Unit.

Mr. Arun Mishra finished his undergraduate degree in Biology from a prestigious university in India. Subsequently Arun finished his first MSc in System Design and Mathematical Modelling from a Dutch university in 2001. Arun worked in the international regulatory arena for number of years including working for Pfizer Global Research and Development Centre in Sandwich UK. In 2006 he was deputed to Pfizer India as Head, Regulatory Affairs. Arun had been an active member of different trade associations involved in shaping the Indian and many key emerging market’s pharmaceutical regulatory environment. In 2008 Arun came back to Pfizer Global Research and Development, Sandwich UK as

Associate Director, Worldwide Regulatory Strategy – Emerging Markets. In this position Arun looked after the regulatory strategy from molecule to market for key emerging markets like India, and oncology products. Meanwhile, Arun pursued his second MSc degree in Pharmaceutical Medicine from Hibernia College, Dublin in 2009 specializing in Pharmaceutical Regulatory Affairs in the Emerging Markets.

Arun left Pfizer Global Research and Development in 2010 and joined GloaxoSmithKline based at Head Office in London as Director, Global Regulatory Affairs (Asia-Pacific, Japan and Emerging Markets).

Dr. Justina A. Molzon, M.S. Pharm., J.D. is a pharmacist and attorney, and a commissioned officer in the U.S Public Health Service. She is currently the Associate Director for International Programs, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration and a member of CDER’s senior management team. One of her primary responsibilities is coordination of CDER’s efforts related to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). In this capacity, she serves as CDER’s representative to the ICH Steering Committee. She also coordinates CDER’s activities related to the President’s Emergency Plan for Aids Relief (PEPFAR) and is involved in technical outreach to the PEPFAR focus countries. She received her B.S. (with honors and distinction) and M.S. in Pharmacy, with a concentration in pharmaceutics and pharmacognosy, from the University of Rhode Island and law degree from the Chicago-Kent College of Law/Illinois Institute of Technology. She is a Fellow in the American Society for Pharmacy Law, serving on its Board of Directors from 1989-1997. Her PHS assignments include serving as a pharmacist on the Navajo Indian Reservation and also the Regional Pharmacist Consultant and Inspector for the Health Care Financing Administration’s Survey and Certification Review Branch, in Chicago. Upon leaving the Public Health Service to go to law school, she was a clinical pharmacist in the critical care area of Northwestern University’s teaching hospital. After law school, she maintained a private law practice and worked with a pro bono legal program for persons with AIDS. In 1990, she rejoined the Public Health Service to work in FDA’s Office of Generic Drugs. In 2008 she was honored with the US Public Health Service Mary Louise Andersen Leadership Award (pharmacist of the year) for extraordinary dedication and leadership in support of global public health. In 2009 she was awarded an exemplary service award by the Surgeon General of the United States for her international efforts and in 2010 received a Dean’s List Award from the University of Rhode Island College of Pharmacy. She is very grateful to have the opportunity to work with international drug regulatory authorities in assuring the safety, efficacy and quality of pharmaceuticals worldwide.

Ms. Deborah Monk holds a Bachelor of Pharmacy and a Diploma in Hospital Pharmacy from the University of Sydney.

She started her working life as a clinical pharmacist in a major teaching hospital in Sydney.

Deborah joined the innovative medicines industry association in mid-1989. She is now the Director of Innovation and Industry Policy at Medicines Australia.

Deborah’s responsibilities within Medicines Australia include seeking to negotiate a more favourable Government industry policy environment that will attract greater global investment to Australia and managing the Ethical Conduct Program.

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Dr. Jacques Morénas is civil servant as « pharmacien général de santé publique » and belongs to the pharmacist-inspector profession. He is graduated as a pharmacist from the faculty of pharmacy (1977) [University of Clermont-Ferrand (France)]. He received his pharmacist inspector degree from the National School for Public Health (1980) [Rennes (France)]

He had different positions in the French health administration in the Ministry of Health and in the regional inspectorate of Paris.

He joined the French Drug Agency in 1993 and is actually assistant director of the Inspection and Companies department in the French Health Products Safety Agency (AFSSAPS), in Saint Denis (France). He is in charge of international affairs (in the field of pharmaceutical and Human products), quality management (for the Inspection and Companies department), including training (for the inspectors of the French Agency). At the European level, he is the AFSSAPS’s representative to the GMDP IWG of European Medicines Agency (EMEA-Londres) and Chair of its “Compliance Group”. At the International level, he is member of the Committee of Officials of the Pharmaceutical Inspection Cooperation Scheme (PIC/S) and its Executive Bureau. He is also involved, as EU expert, in ICH discussions concerning implementation of Q8, Q9 and Q10 documents and he is participating to the WHO program on pre-qualification of vaccines (assessment of National Regulatory Authorities). He is member of the French National Academy of Pharmacists.

Dr. Patricia Mozzicato In the mid-1990s, Patricia Mozzicato, M.D. joined Bristol-Myers Squibb Pharmaceutical Research Institute as a drug safety physician where she was responsible for safety monitoring of marketed oncology and antiretroviral products. While at B-MS, she became a physician advisor for implementation of MedDRA Version 2.1, including conversion of legacy data. She trained most of the initial BM-S users of MedDRA and became the primary physician responsible for mapping new verbatim terms to MedDRA and for making recommendations for Change Requests to the MSSO. She also established and chaired the MedDRA committee of B-MS’s drug safety department.

In 2001, Dr. Mozzicato joined the MedDRA Maintenance and Support Services Organization (MSSO) where she is currently Chief Medical Officer. She has several responsibilities at the MSSO including terminology development and maintenance, and medical support for various MSSO products and services. She is a member of the CIOMS Working Group for Standardised MedDRA Queries (SMQs) and is the MSSO representative on the ICH “Points to Consider” Working Group.

After graduation from Tufts University School of Medicine, Dr. Mozzicato trained in pathology/neuropathology at the University of Vermont College of Medicine and at Queen’s University/Kingston General Hospital in Ontario, Canada. She practiced pathology for several years in Syracuse, New York. She is certified by the American Board of Pathology in anatomic and clinical pathology and has obtained Special Qualification in neuropathology.

Dr. Hidefumi Nakamura, PhD is a Chief of the Divisioin for Clinical Trials, Clinical Research Center, National Center for Child Health and Development (NCCHD), Tokyo. He is a pediatrician and a pediatric pharmacologist trained at the National Medical Center, Tokyo (1989-91), Hospital for Sick Children, Toronto, ON, Canada (1991-1996) and the Rainbow Babies and Childrens Hospital, Cleveland, OH USA (1996-1999). He also has experience

as a senior reviewer at the Pharmaceutical and Medical Devices Evaluation Center, the former body of the Pharmaceutical and Medical Devices Agency(PMDA) (2000-2002). His team is currently receiving a grant for COE for pediatric clinical trial network in Japan. He is currently a member of the following: the advisory board for the PMDA, the Pediatric Working Group for the council for off-label and unlicensed drugs by the Ministry of Health, Labour and Welfare (LHLW) , the Committee on Drugs of Japan Pediatric Society, the Steering Committee (vice chairman) for the Japan Society of Developmental Pharmacology and Therapeutics, an.d the IUPHAR. Executive Committee of the Pediatric Clinical Pharmacology Section.

Ms. Jalene Poh is a regulatory consultant with the Pharmaceutics & Biologics Branch of the Singapore Health Sciences Authority (HSA). She received her pharmacy degree at the National University of Singapore and was practicing as a pharmacist prior to joining HSA. Throughout her 10 years in the Agency, besides her primary role in clinical evaluation of drug application submissions, she was also involved in project management for new drug submissions, regulatory processes and policies as well as drafting of regulatory guidance documents.

Dr. Lembit Rägo was, before joining the World Health Organization (WHO), Professor of Clinical Pharmacology (Tartu University, Estonia) and the founder and first Director General of the Estonian Drug Regulatory Authority, State Agency of Medicines. In December 1999, Dr Rägo joined WHO Headquarters in Geneva, as Coordinator of the Quality Assurance and Safety: Medicines (QSM) team (nowadays in the Department of Essential Medicines and Pharmaceutical Policies). In 2001 he initiated, in addition to the units routine work, the WHO Prequalification Programme. He is a WHO observer to the ICH Steering Committee and to the ICH Global Cooperation Group (GCG). He is also a Vice-Chairman of the Uppsala Monitoring Centre Board. During 2002 to 2004 he was a member of the Council of International Organizations of Medical Sciences (CIOMS) Working Group on Pharmacogenetics (which resulted in a book “Pharmacogenetics. Towards improving treatment with medicines”, CIOMS, 2005). He is also serving as designated Technical Officer for several professional NGOs in official relations with WHO (such as CIOMS and IUPHAR). He is a common speaker in DIA Annual meetings and has a number of scientific and regulatory affairs related publications.

Ms. Dato’ Eisah A. Rahman, Senior Director of Pharmaceutical Services. Ministry of Health Malaysia graduated as a pharmacist from the Curtin University of Technology, Western Australia in 1977. She later obtained a postgraduate degree, M. Sc in Pharmaceutical Analysis from the University of Manchester, United Kingdom in 1986. She has served the Ministry of Health Malaysia as a pharmacist since 1979 to date and has held several key positions throughout her 30 over years of service with the ministry.

She first started her career as a pharmacist at the National Pharmaceutical Control Bureau (NPCB) and appointed as Head of Pharmaceutical Microbiology Laboratory, Head of GMP and Licensing Section, Deputy Director of Centre for Product Registration and later in 2006 became Director of National Pharmaceutical Control Bureau. In 2007, she moved on to become Director of Pharmacy Enforcement and in 2008 was promoted to become Senior Director of Pharmaceutical Services, Ministry of Health where she takes charge of the entire pharmacy programme in Malaysia.

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Throughout her career, she has contributed tremendously to the overall development of the pharmacy service and the domestic pharmaceutical sector. Besides her involvements in various committees at national level, she has also participated in several healthcare related meetings and conferences in the international arena particularly in the area pertaining to drug regulations.

With her vast experience in the area of regulatory control and her involvement in ASEAN harmonisation initiatives for pharmaceuticals, she is now the Chair of ASEAN Consultative Committee for Standards and Quality (ACCSQ) Pharmaceutical Product Working Group. She has also been appointed as a WHO Expert Advisory Panel on Drug Policies and Management.

Dr. Peter Richardson, is a pharmacist, with a Ph.D. in pharmaceutics from The Queens University, Belfast. He worked for a number of years in the pharmaceutical industry in the UK and Italy in the area of formulation research and development, with companies such as Bristol-Myers Squibb, SmithKline Beecham, Pfizer and Serono, concentrated mainly on the development of drug delivery systems. He has worked for the UK MHRA as a pharmaceutical assessor, with some time assessing chemical and abridged applications and wide ranging experience of biotechnology/biological applications. He was UK delegate for the Biologics Working Party of the CHMP prior to joining the European Medicines Agency. His role as Head of Biologicals in Quality of Medicines sector requires scientific and regulatory input into many aspects of biotechnology and biological medicinal products, CHMP, Biologics, Cell and Gene Therapy Working party, Blood products Working party, Vaccines and Similar Biologicals Working Parties activities.

Dr. Romi Singh has extensive scientific and management experience in top-tier pharmaceuticul and biotechnology companies such as Burroughs/GlaxoWellcome, Merck and Amgen. He is well published in drug discovery, preclinical development and is internationally recognized as an expert on regulatory affairs, clinical trials and drug registrationss in developing countries. He is actively involved in advancing regulatory policy for biologies and small molecules in emerging countries through various advocacy and outreach efforts. He is a lecturer at various universities and holds an adjunct faculty position at Thomas Jefferson University. Dr. Singh is currently an Executive Director of Global Regulatory & Safety at Arngen. He obtained an undergraduate degree from St. Stephen’s College, doctorate from the University of Washington.

Dr. Jean Temeck is certified by the American Academy of Pediatrics in general pediatrics and in pediatric endocrinology. She graduated from the Georgetown University School of Medicine. She received her training in general pediatrics at the St. Louis Children’s Hospital and the Cardinal Glennon Memorial Hospital for Children in St. Louis. After completing a fellowship in pediatric endocrinology at The New York Hospital Cornell Medical Center, she joined their faculty as an Assistant Professor of Pediatrics and was appointed Director of the Pediatric Diabetes Clinic. Dr. Temeck joined the Food and Drug Administration in 1987. She is currently the International Team Lead in the Office of Pediatric Therapeutics where she coordinates the monthly exchanges of information between the FDA, the European Medicines Agency or EMA, Health Canada and Japan’s Pharmaceuticals and Medical Devices Agency or PMDA.

Dr. Yoshiaki Uyama is currently Director, Regulatory Science Research Division, Office of Regulatory Science, Pharmaceuticals & Medical Devices Agency (PMDA). He leads the research of regulatory science in PMDA and coordinates PMDA’s activities relating to regulatory science. He is also the leader for PMDA Omics Project (POP).

He received his Ph.D. degree from the Nagoya City University in 1994 and became a research fellow for Japan society for the promotion of science. He was a post-doctoral fellow in University of Calgary, Canada in 1994-1995 before being a researcher in the Tokyo Metropolitan Institute of Medical Science (1995-1998). In 1998, he joined to the Ministry of Health and Welfare (present: Ministry of Health, Labour & Welfare) as a technical officer. He started his review for new drugs in Pharmaceuticals & Medical Devices Evaluation Center of National Institute of Health Science (PMDEC) in 2001 and continues his career on drug review in PMDA since April 2004, including the career as the Review Director (2007-2010), ICH Technical Coordinator (2004-2009) and the topic leader of ICH E15 and E16.

Dr. An Vermeulen, PhD, is a Senior Director in the Clinical Pharmacology Division at Janssen Research & Development and is the Global Head of the Advanced Modeling & Simulation group.

An joined the Preclinical Pharmacokinetics group of the Janssen Research Foundation in 1992, moving on to the Clinical Pharmacokinetics department in 1999. As a pharmacokineticist she has made significant contributions to the preclinical and clinical development of many marketed products such as SPORANOX, LIVOSTIN, REMINYL, RISPERDAL, RISPERDAL CONSTA, INVEGA and INVEGA SUSTENNA, and to numerous products in development at J&J. In December 2001, An joined the J&J PRD Advanced PK/PD Modeling and Simulation group to develop her modeling, simulation and managerial competencies.

Since May 2006 An has global responsibility for the Advanced PK/PD Modeling and Simulation group. Under her leadership, the group supports development decisions and filing activities for NMEs and line extensions, using modeling and simulation approaches as strategic tools in support of compound selection, dose and dose-regimen selection, and clinical trial design optimization. The group is also active in quantitative pharmacology and translational research at the preclinical-clinical interface, and in quantitative “landscape analysis” of efficacy and safety attributes of our development candidates relative to competitor products.

An holds a Pharmacy degree and Ph.D. in Pharmaceutical Sciences from the University of Ghent, Belgium. During her career, An has (co)authored more than 30 peer reviewed publications in scientific journals and book chapters. Furthermore, An represents Janssen Research & Development and co-leads the PK/PD Modeling Platform under the umbrella of the Dutch Top Institute Pharma, a public-private partnership of eleven academic and industry groups to develop mechanistic PKPD modeling technologies in the fields of schizophrenia, cardiovascular safety, and other domains in drug discovery and development.

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Ms. Chao-Yi (Joyce) Wang, Senior Specialist, Division of Drugs and New Biotechnology Products, Taiwan Food and Drug Administration, Department of Health, Taiwan.

Education: LL. M. (Master of Law), Department of Law, Soochow University, Taipei, Taiwan. M. S., Department of Preventive Medicine, College of Medicine, Ohio State University, USA

Work Experience & Training:• Section Chief, Division of Drugs and New Biotechnology

Products, Taiwan Food and Drug Administration, Jan. 2010- Jan. 2011

• Section Chief, Bureau of Pharmaceutical Affairs, Department of Health, Nov. 2006- Dec. 2009

• Specialist, Bureau of International Cooperation, Department of Heath, Nov, 2004- Oct. 2006

• Visiting Scholar, Fulbright Foundation, USA, 2003• Executive Education, John F. Kennedy School of Government,

Harvard University, USA, 2007

Dr. Rebecca Wang, FRCP, FACC, Head, Regional Center for Asia Pacific, Roche Product Development Safety Operation, Shanghai Roche Pharmaceutical Ltd. Rebecca serves a dual role as the Director of Safety Management at Shanghai Roche Pharmaceuticals Ltd as well as the Head of the Regional Center for Asia Pacific for Roche Product Development Safety Operation. She leads a safety operation group in Beijing and a safety evaluation group in Shanghai since joining Roche in 2007.

Rebecca has worked in industry since 1999 . She had worked as a Clinical Research Physician in Heart Failure and Hypertension. AstraZeneca LP US, Senior Medical Medicator of Cardiovascular Products, Global Medical Affairs at Weyth US and Senior Medical Director of Clinical Drug Safety, AstraZeneca US. As the Global Drug Safety Physician for Crestor in AstraZeneca from 2003-7, she led the global Crestor safety surveillance team in performing safety signal detection and anslysis, preparing periodic safety reports and regulatory submissions and imlementing a rigorous pharmacoviglance program on Crestor worldwide.

Prior to her entry into the industry, Rebecca had held various academic and professional positions includng Chief of Cardiology , Philadelphia Geriatric Center and Chief of Cardiology in the University of Hong Kong. She was lsited as one of the top cardiologists for seniiors in the Philadelphia Magazine in June 1998.

Rebecca received Her MD from the University of Hong Kong. She is Board Certified in the areas of Geriatric Medicine, Cardiovasculatr Disease and Internal Medicine. She has contributed more than 70 publications to various peer reviewed journals.

Mr. Mike Ward joined Health Canada in 1986 following nine years industrial experience in the QA/QC area. Since that time he has held a variety of regulatory positions including GMP specialist, premarket Quality reviewer and manager, and senior policy analyst. Mike is Manager of the International Programs Division of the Therapeutic Products Directorate of Health Canada. He served as the Canadian Observer to the ICH Steering Committee and a former regulatory co-chair of the Global Cooperation Group. He chairs the Regulatory Harmonization Steering Committee of the APEC Life Sciences Innovation Forum and is an alternate representative for NAFTA on the PanAmerican Regulatory Harmonization Steering Committee.

Mr. Adrian Waterson is a Pharmacist by training with 30 years’ experience spanning many of the key areas of the Pharmaceutical Industry, including R&D, Manufacturing and Commercial.

Adrian has worked in development roles in pre-formulation research and in formulation development. These have including the design of solid, liquid and freeze dried formulations and instrumented tablet presses. Adrian then took these skills to the manufacturing environment in technical and leadership roles including Management of a sterile products plant.

Following a period in a commercially lead emerging markets business unit, Adrian has spent the last 10 years in Regulatory Affairs leadership roles mainly focused on Latin America, Middle East, Africa, Eastern Europe and Asia Pacific.

Adrian works for AstraZeneca and is currently Regulatory Director for Asia Pacific and Regulatory Portfolio Leader for Oncology, Infection, Respiratory and Inflammation across all International Markets.

Mr. Kum Cheun Wong, Director Global Regulatory Policy and Intelligence, Asia Pacific, Janssen (a divison of Johnson & Johnson Pte Ltd) Pharmaceutical Companies of Johnson & Johnson

Kum Cheun (KC) is Director Global Regulatory Policy & Intelligence Asia Pacific in Janssen based in Singapore. KC leads in the development of regulatory policy guidance and intelligence for AP region. He is active in regional pharmaceutical harmonization activities in Asia Pacific including the ASEAN PPWG harmonization and APEC LSIF. He is member and technical expert of the ASEAN Pharmaceutical Research Industry Association (APRIA) involved in the technical discussion with the ASEAN regulators, member of ISPE and trade association regional regulatory networks.

Prior joining J&J in 2007 as Associate Director, Global Regulatory Policy & Intelligence Asia, KC was with Gillette Asia Pacific (P&G) where he developed regulatory strategy, systems and processes to provide product registration and regulatory compliance for consumer, cosmetics and medical devices for the AP region.

He was the former Drug Registration Branch’s Deputy Head responsible for leading a team of regulators in the Quality Evaluation and Submissions section of the Centre for Drug Administration at the Singapore Health Sciences Authority. He was actively involved in the development of Singapore’s registration regulations and policies, and contributed to the ASEAN Harmonization of Pharmaceutical Products technical guidelines such as the ASEAN Process Validation Guideline and Stability Guideline for product registration.

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25notes

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