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

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Asia Regulatory Conference: Asia’S Role in Global Drug Development April 26-28, 2011 Grand Hilton Hotel, Seoul, Republic of Korea Asia Regulatory Conference: Asia’s Role in Global Drug Development April 26-28, 2011 Grand Hilton Hotel, Seoul, Republic of Korea Co-sponsored by the APEC Harmonization PROGRAM COMMITTEE CHAIR Center, DIA, and the International Federation of André W. Broekmans Pharmaceutical Manufacturers & Associations Vice President, Most of World Regulatory Policy & (IFPMA) Regulatory Affairs, MSD, The Netherlands (ICH SC and GCG Member) Join representatives from more than 20 Asian and ICH regulatory PROGRAM COMMITTEE CO-CHAIR agencies and industry professionals to discuss regulatory Sun Hee Lee Director, Drug Evaluation Department aspects of ICH, APEC and ASEAN harmonization initiatives, good Korea Food and Drug Administration (KFDA), regulatory practices, quality and GMP, global drug development, Republic of Korea (ICH GCG Member) and pharmacovigilance. This three-day conference provides a unique opportunity to: PROGRAM COMMITTEE MEMBERS Laetitia Bigger • StrengthencooperationbetweenAsianregulatoryauthorities Manager, Regulatory & Scientific Affairs and pharmaceutical industry IFPMA, Switzerland Julie Dennis • Facilitatediscussiononcommonissuesintheregulatoryand Senior Director, Worldwide Regulatory Strategy, technical areas in the Asia Pacific region Emerging Markets, Pfizer, UK Weon Do • Encouragegreaterharmonizationofregulatoryrequirementsin Head of Regulatory Affairs & Market Access the Asia Pacific region sanofi-aventis, Republic of Korea Ziqun Han Manager, Regulatory Policy & Intelligence Abbott Laboratories, UK WHO SHOULD ATTEND Sascha Haverfield-Gross Professionals involved directly and/or indirectly in regulatory Deputy Vice President, Scientific & Regulatory Affairs andclinicalresearch,orwhoareconsideringinitiatingtheir PhRMA, USA activities in this professional area, including: Tiffany Hoang • Research professionals (clinical, laboratory, site members, Regional Senior Manager Global Regulatory Strategy, Policy & Safety - Asia Pacific and CRAs) MSD, Singapore • CROs and SMOs In-Jin Jang • Service providers Seoul National University, Republic of Korea • Clinical investigators (active and potential) (Program Committee Members and Advisory Committee continued on page 2) • Ethics committees • Regulatory agencies • Medical education institutions CONTACT INFORMATION • Pharmaceutical sponsors Forgeneralinquiriesandregistration,contactLisaT.Robinsonat [email protected] Simultaneous translation in Korean will be available. Worldwide Headquarters Drug Information Association, Inc. 800 Enterprise Road, Suite 200 Presented by Horsham, PA 19044, USA www.diahome.org Regional Offices Basel, Switzerland Tokyo, Japan Mumbai, India Beijing, China 2 ADVISORY COMMITTEE PROGRAM COMMITTEE MEMBERS (Continued from page 1) Yves Juillet DIA President Elect Yuppadee Javroongrit Senior Advisor, LEEM, France, (APEC Harmonization Center Assistant Director and Head of International Affairs and IND Advisory Board Member) Section Drug Control Division Thai FDA, Thailand Tatsuo Kurokawa (ICH GCG Observer for ASEAN, Co-Chair of ASEAN ACCSQ Chiba University Graduate School of Pharmaceutical PPWG) Sciences, Japan Justina A. Molzon Tae-Gyun Kim Associate Director, International Programs, Center for Drug Deputy Director, Center for Drug Development Assistance Evaluation and Research (CDER), Food and Drug Administration Korea Food and Drug Administration (KFDA), (FDA), USA (ICH SC and GCG Member, Chair of the APEC RHSC Republic of Korea Subcommittee on Training) Yil-Seob Lee Lembit Rägo Director, Medical & Regulatory Affairs Coordinator, Quality Assurance & Safety for Medicines (QSM) GlaxoSmithKline, Republic of Korea World Health Organization (WHO), Switzerland, (WHO ICH SC and GCG Observer) John C.W. Lim Sang-Goo Shin Chief Executive Officer, Health Sciences Authority (HSA), President Singapore KoNECT – Korea National Enterprise for Clinical Trials Christina Lim Republic of Korea Group Director, Health Products Regulation Group Larisa Nagra Singh Health Sciences Authority (HSA), Singapore Senior Director, Clinical Operations Asia Pacific, ICON Clinical (ICH GCG Member) Research, India Arun Mishra Ling Su Director, Global Regulatory Affairs Senior Vice President and Head of Development Greater China GlaxoSmithKline, UK Novartis, P.R. China Mike Ward Seiji Miyazawa Manager, International Program Division, Health Products and Food Director, International Affairs Branch, Health Canada, Canada, (ICH SC and GCG Member, Chair of JPMA, Japan the APEC RHSC) Odette Morin Director, Regulatory and Scientific Affairs IFPMA, Switzerland Regulatory participants from more than 20 (Director of ICH Secretariat, ICH SC and GCG Member) countries and regions: Chang Won Park Australia | Bangladesh | Brunei Darussalam | Cambodia | Deputy Director, Drug Approval and Review Management Division, Korea Food and Drug Administration (KFDA), Canada | Chinese Taipei | European Union | Hong Kong | Republic of Korea India | Indonesia | Japan | Laos | Macau SAR | Malaysia | Kui Lea Park Director, Center for Drug Safety Assistance Myanmar | New Zealand | Pakistan | People’s Korea Food and Drug Administration (KFDA), Republic of China | Philippines | Republic of Korea | Republic of Korea Singapore | Sri Lanka | Thailand | USA | Vietnam Jae-Gook Shin Professor & Director Department of Clinical Pharmacology & Clinical Trial Center Inje University Busan Paik Hospital, Republic of Korea Networking Opportunities Romi Singh Build on existing contacts and make new ones. Executive Director This meeting provides extensive networking opportunities - Global Regulatory Affairs & Safety Amgen, USA all included in your registration fee. Jiwung Son Hanmi Pharmaceuticals, Republic of Korea Soo Kyung Suh Welcome Reception Deputy Director, Advanced Therapy Products Division Tuesday, April 26, 2011, 5:30 pm-7:00 pm Korea Food and Drug Administration (KFDA), Republic of Korea See page 8 for details. Adrian Waterson Asia Regulatory Director AstraZeneca, UK Network on the Exhibition Floor Tae Moo Yoo See page 8 for details. Director, Drug Approval and Review Management Division, Korea Food and Drug Administration (KFDA), Republic of Korea PLEASE NOTE: All refreshment breaks, lunches, and reception will be held in the Emerald Hall and Foyer. 3 DAY 1 | TUESDAY, APRIL 26 Expanding Participation in ICH Technical Working Groups to Regional Harmonization Initiatives (RHIs) and Drug Regulatory Agencies (DRAs) 7:30 AM-8:30 AM CONFERENCE REGISTRATION Mr. Mike Ward Manager, International Program Division, Health Products and Food Branch, Health Canada, Canada, (ICH SC and GCG 9:00 AM-9:40 AM OPENING CEREMONY Member, Chair of the APEC RHSC) Session ChairS KFDA’s Perspectives on the Implementation of Dr. Sun Hee Lee ICH Guidelines Director, Drug Evaluation Department, Korea Food & Drug Administration (KFDA), Republic of Korea (ICH Global Dr. Sun Hee Lee Cooperation Group (GCG) Member) Director, Drug Evaluation Department, Korea Food & Drug Administration (KFDA), Republic of Korea (ICH GCG Member) Dr. André W. Broekmans Vice President, Most of World Regulatory Policy & Regulatory Affairs, MSD, The Netherlands (Program Committee Chair, ICH Steering Committee (SC) Member) 12:00 PM-1:00 PM LUNCH BREAK Opening Remarks Dr. Seung Hee Kim Director General, National Institute of Food and Drug Safety 1:00 PM–3:30 PM PLENARY SESSION Evaluation, Korea Food & Drug Administration (KFDA), Regional Harmonization Initiatives Republic of Korea (Director of APEC Harmonization Center) Session ChairS Congratulatory Remarks Dr. Justina A. Molzon Associate Director, International Programs, Center for Drug Dr. Yun Hong Noh (to be confirmed) Commissioner, Korea Food & Drug Administration (KFDA), Evaluation and Research (CDER), Food and Drug Administration Republic of Korea (FDA), USA (ICH SC and GCG Member, Chair of the APEC RHSC Subcommittee on Training) Congratulatory Remarks Ms. Weon Do Dr. Bup Wan Kim Head of Regulatory Affairs and Market Access, sanofi-aventis, President, Korea Health Industry Development Institute, Republic of Korea (KHIDI), Republic of Korea The Role of APEC in Advancing Harmonization Efforts Welcome from the International Federation of in a More Strategic, Effective and Sustainable Fashion Mr. Ding Jianhua Pharmaceutical Manufacturers & Associations (IFPMA) Mr. Mike Ward Deputy Director General, Department of Inter- Dr. Odette Morin Manager, International Program Division, Health Products national Director, Regulatory and Scientific Affairs, IFPMA, Switzerland and Food Branch, Health Canada, Canada, (ICH SC and GCG Cooperation, State Food and Drug Administra- (Director of ICH Secretariat, ICHSC and GCG Member) Member, Chair of the APEC RHSC) tion (SFDA), P.R. China (ICH GCG Member) (to Welcome from the Drug Information Association (DIA) be confirmed) AHC Activities: Current Status and Future Prospects Dr. Yves Juillet Dr. Tae-Gyun Kim Dr. Kui Lea Park DIA President Elect KFDA (to be confirmed) Director, Center for Drug Development Assistance, Korea Food & Drug Administration (KFDA), Republic of Korea 9:40 AM–10:00 AM REFRESHMENT BREAK ASEAN Regulatory Harmonization Activities and Future Perspectives Dr. Yuppadee Javroongrit 10:00 AM–12:00 PM PLENARY SESSION Assistant Director & Head of International Affairs & IND Update on ICH Activities, Focus on New Activities Section Drug Control Division, Food and Drug Administration Session ChairS (FDA), Ministry of Public Health, Thailand (ASEAN ICH GCG Dr. Sun Hee Lee Observer, Co-Chair of ASEAN ACCSQ PPWG) Director, Drug Evaluation Department, Korea Food & Drug Tripartite
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