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

April 26-28, 2011 Grand Hilton Hotel , Republic of PROGRAM

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.

Contact information For general inquiries contact Lisa T. Robinson at [email protected] Worldwide Headquarters Drug Information Association, Inc. 800 Enterprise Road, Suite 200 Horsham, PA 19044, USA www.diahome.org Presented by Regional Offices Basel, , Mumbai, India Beijing, 2

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

Contact information For general inquiries and registration, contact Lisa T. Robinson at [email protected] AGENDA 1

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, -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, ICH SC 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 Symposium on Rationalization of Clinical Administration (KFDA), Republic of Korea (ICH GCG Member) Trial Requirements Dr. André W. Broekmans Ms. Hee Young Park Vice President, Most of World Regulatory Policy & Regulatory Korea Food & Drug Administration (KFDA), Republic of Korea Affairs, MSD, The Netherlands (Program Committee Chair, Mr. Shinobu Uzu ICH SC and GCG member) Director, International Planning, Ministry of Health, Labour and 20 Years of ICH: Learning and Accomplishments Welfare (MHLW), Japan (ICH SC Member and GCG Co-Chair) Dr. Justina A. Molzon Dr. Li Jinju Associate Director, International Programs, Center for Division Director, Division of Drug Research Supervision Drug Evaluation and Research (CDER), Food and Drug Department of Drug Registration, State Food and Drug Administration (FDA), USA (ICH SC and GCG Member, Chair Administration (SFDA), P.R. China of the APEC RHSC Subcommittee on Training)

Japan’s Experience with ICH and the Implementation 3:30 pm–4:00 pm Refreshment Break of Guidelines Mr. Shinobu Uzu Director, International Planning, Ministry of Health, Labour and Welfare (MHLW), Japan (ICH SC Member and GCG Co-Chair) 2

4:00 pm-5:30 pm PARALLEL tracks

Track 1: Fighting Counterfeit Medicines in Emerging Countries: Addressing Infrastructure and Capacity Gaps Session Chairs Dato’ Eishah A. Rahman Senior Director, Pharmaceutical Services Division, Ministry of Health, Malaysia Mr. Arun Mishra Director, Global Regulatory Affairs, GlaxoSmithKline, UK

Counterfeit Medicines in Asia Today Singapore’s Experience in the Fight Against Mr. Thomas Kubic Counterfeits President and CEO of the Pharmaceutical Security Ms. Ruth Lee Choo Ai Institute, USA Acting Director, Enforcement Branch, Health Products The Malaysian Experience with Meditag Regulation Group, Health Sciences Authority (HSA), Singapore Dato’ Eishah A. Rahman Senior Director, Pharmaceutical Services Division, Ministry of Health, Malaysia

Track 2: Ensuring Quality – Enhance the Approach of Quality Driven by ICH Q8, Q9, Q10, and Q11: What about Practical Implementation? Session Chairs Dra. Kustantinah Head, National Agency of Drug and Food Control (NA-DFC/BPOM), Indonesia Dr. Georges Vice President, Global Quality Strategy and International Affiliate Quality and Compliance (IAQC), , UK (ICH Quality Implementation Working Group (ICH Q-IWG) Member)

ICH Q-IWG Updates and Challenges CMC Requirements to Support New Technology in Dr. Georges France Development and Analytical Methods (e.g. NIR, UPLC) Vice President, Global Quality Strategy and International Dr. Moheb Nasr Affiliate Quality and Compliance (IAQC), Pfizer, UK (ICH Director, Office of New Drug Quality, Center for Drug Quality Implementation Working Group (ICH Q-IWG) Evaluation and Research (CDER), Food and Drug Member) Administration (FDA), USA (ICH Q-IWG Member) Dr. Jean-Louis Robert Validation and Continuous Verification: Regulatory Head of Division, National Health Laboratory, Department Challenges of Quality Control of Medicine, Luxembourg (Rapporteur Dr. Yukio Hiyama of ICH Q-IWG) Chief, Third Section, Division of Drugs, National Institute of Health Sciences (NIHS), Ministry of Health, Labour and Welfare (MHLW), Japan (ICH Q-IWG Member)

Track 3: Practical Uses of Common Technical Documents (CTDs) in Asia Session Chairs Dr. Lembit Rägo Coordinator, 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 Wong Director, Global Regulatory Policy & Intelligence, Asia Pacific, Johnson & Johnson, Singapore

Experience and Value of CTD Practical Use and Value of CTD in Clinical Trials and Ms. Jalene Poh New Drug Application (NDA), and Challenges Faced in Regulatory Consultant, Pharmaceuticals & Biologics Branch, the Asia Region Pre-Marketing Division, Health Products Regulatory Group, Mr. Alistair Davidson Health Sciences Authority (HSA), Singapore Senior Director, Regulatory Affairs, Practical Use of ICH CTD in Facilitating Approval Asia-Pacific, PPD, UK of Prequalification of Pharmaceutical Products and the Benefits to the WHO Program Dr. Lembit Rägo Coordinator, Quality Assurance & Safety for Medicines (QSM), Essential Medicines Pharmaceutical Policies Department, World Health Organization (WHO), Switzerland (WHO ICH SC and GCG Observer)

5:30 pm-7:00 pm Welcome Reception — Emerald Hall & Foyer 3 day 2 | Wednesday, April 27

8:30 am–10:00 am plenary Session 10:30 am–12:30 pm plenary Session Early Clinical Development in Asia Late Clinical Development in Asia Session Chairs Session Chairs Professor In-Jin Jang Dr. Herng-Der Chern Seoul National University, Republic of Korea Distinguished Researcher, Center for Drug Evaluation (CDE), Dr. A. Ramkishan Chinese Taipei Asst. Drugs Controller, CDSCO, Sub Zonal Office, India Mr. Adrian Waterson Asia Regulatory Director, AstraZeneca, UK Current Status of Early Clinical Development in Asia and Plan for the Future: Industry Perspective Simultaneous Multi-regional Clinical Trials Dr. Ken Kobayashi Dr. Moira Daniels Head of Clinical Science Oncology, Johnson & Johnson, Japan Vice President, Regulatory Affairs, AstraZeneca, UK Regulatory Experience in Early Clinical Trial Approval Acceptance of Clinical Data – The Challenge of Dr. A. Ramkishan Generalizability Asst. Drugs Controller, CDSCO, Sub Zonal Office, India Dr. Yuki Ando Principal Reviewer of Biostatistics, Office of New Drug II, How Asian Clinical Sites are Working for Early Clinical Pharmaceuticals and Medical Devices Agency (PMDA), Japan Trials Professor In-Jin Jang Towards Simultaneous Regulatory Approval Seoul National University, Republic of Korea Dr. Herng-Der Chern Distinguished Researcher, Center for Drug Evaluation (CDE), 10:00 am–10:30 am Refreshment Break Chinese Taipei

12:30 pm-1:30 pm lUNCh Break

1:30 pm-3:30 pm PARALLEL tracks

track 1: Establishing the Asia Pacific Region as an Important Partner in Global Pediatric Development Session Chairs Dr. Min Soo Park Director, Clinical Trials Center, Chair, Department of Clinical Pharmacology, Yonsei University, Republic of Korea Mrs. Angelika Joos Head, Regulatory Policy, EU & Most of World, MSD (Europe), Belgium

Participation in Asia in Global Pediatric Programs, FDA’s Experience with Global Pediatric Development Including Cultural Barriers to Conduct Pediatric Dr. Jean W. Temeck Clinical Trials Lead Medical Officer, Office of Pediatric Therapeutics (OPT), Dr. Hidefumi Nakamura Office of International and Special Programs (OISP), Office Director, Division of Clinical Research, National Center for of the Commissioner (OC), Center for Drug Evaluation and Child Health and Development, Japan Research (CDER), Food and Drug Administration (FDA), USA How to Extrapolate Clinical Development Results Position of WHO ICDRA on Global Pediatric to Asia Children: Usefulness of Bridging the Development Program with Adults Ms. Agnes Chan Dr. An Vermeulen Regulatory Consultant, Pharmaceuticals & Biologics Branch, Head, Modeling & Simulation Department, Johnson & Health Products Regulation Group, Health Sciences Authority Johnson, Belgium (HSA), Singapore

Track 2: Ensuring Quality: Harmonizing and Optimizing Inspection Approach in the Global Environment Session Chairs Dr. Yukio Hiyama Chief, 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 France Vice President, Global Quality Strategy and International Affiliate Quality and Compliance (IAQC), Pfizer UK (ICH Q-IWG Member)

Control Strategy and Batch Release: Challenges for Quality Risk Management in the WHO a Global and an Harmonized Approach Prequalification Process Dr. Jacques Morénas Dr. Lembit Rägo Assistant Director, Inspectorate and Companies Depart- Coordinator, Quality Assurance & Safety for Medicines ment, The French Health Products Safety Agency (AFS- (QSM), Essential Medicines Pharmaceutical Policies SAPS), France (ICH Q-IWG Member, PIC/S) Department, World Health Organization (WHO), Switzerland (WHO ICH SC and GCG Observer)

(Parallel Tracks continued on next page) 4

1:30 pm-3:30 pm PARALLEL tracks (Continued)

API: Role of EDQM in Globalization, Input on Dr. Jacques Morénas Inspections and Standards Assistant Director, Inspectorate and Companies Department, Dr. Susanne Keitel The French Health Products Safety Agency (AFSSAPS), France Director, European Directorate for the Quality of Medicines (ICH Q-IWG Member, PIC/S) & Healthcare (EDQM), Council of Europe, France Dr. Lembit Rägo Coordinator, Quality Assurance & Safety for Medicines (QSM), Panel Discussion: CMC Harmonization and Essential Medicines Pharmaceutical Policies Department, Regulatory Challenges World Health Organization (WHO), Switzerland (WHO ICH SC Chair and GCG Observer) Dr. Georges France Dr. Susanne Keitel Vice President, Global Quality Strategy and International Director, European Directorate for the Quality of Medicines & Affiliate Quality and Compliance (IAQC), Pfizer UK (ICH Healthcare (EDQM), Council of Europe, France Q-IWG Member) Dra. Kustantinah Panelists Head, National Agency of Drug and Food Control (NA-DFC/ Dr. Moheb Nasr BPOM), Indonesia Director, 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 Hiyama Chief, Third Section, Division of Drugs, National Institute of Health Sciences (NIHS), Ministry of Health, Labour and Welfare (MHLW), Japan (ICH Q-IWG Member) Dr. Rohan Hammett National Manager, Therapeutic Goods Administration (TGA), Australia (to be Track 3: Ethical Business Practices: Towards Better Marketing Compliance confirmed) Session Chairs Dr. Megan Keaney Principal Medical Adviser, Therapeutic Goods Administration (TGA), Australia Mr. In-Bum Kim Sr. Director, Korean Research-based Association (KRPIA), Republic of Korea

Latest Developments on Ethical Business Practices Update on New RDPAC Code and Latest (EBP) in Australia Developments in China Dr. Megan Keaney Ms. Jennifer Chen Principal Medical Adviser, Therapeutic Goods Administration Director, Legal Affairs, R&D-based Pharmaceutical (TGA), Australia Association Committee (RDPAC), P.R. China Ms. Deborah Monk Code Compliance Governance in Japan Director, Innovation and Industry Policy, Mr. Yota Kikuchi Medicines Australia, Australia Manager, Promotion Code & Public Affairs, sanofi-aventis, Japan (Vice Chair of Japan Pharmaceutical Manufacturers Association (JPMA) Promotion Code Working Committee)

3:30 pm–4:00 pm Refreshment Break

4:00 pm–5:30 pm plenary Session Similar Biotherapeutic Products (SBPs) in Asia: Opportunities and Challenges in Regulatory Evaluation Session Chairs Dr. Sannie Chong Evolving Regulatory Landscape for SBPs in Asia Acting Director, Generics and Biosimilars Branch, Health Dr. Fermin Ruiz de Erenchum Sciences Authority (HSA), Singapore Leader, Special Regulatory Task Force, Hoffmann-La Roche Dr. Fermin Ruiz de Erenchum Ltd., Switzerland (Chair of IFPMA Biotherapeutic Group) Leader, Special Regulatory Task Force, Hoffmann-La Roche Ltd., Chinese Taipei’s Perspectives of Regulation Switzerland (Chair of IFPMA Biotherapeutic Group) of Biosimilar Medicine Do We Have a Common Understanding? Definitions Ms. Joyce Wang of SBPs and Principles in Evaluating SBPs Division of Drugs & New Biotechnology Products, Food and Dr. Peter Richardson Drug Administration, Department of Health, Chinese Taipei Responsible for Biological Quality of Medicines, Human Medicines Development and Evaluation, European Medicines Agency (EMA), UK

(Session continued on next page) 5 day 3 | Thursday, April 28

8:30 am–10:00 am plenary Session The Role of MedDRA in Pharmacovigilance Activities Electronic Submissions and eCTD as Vehicle to Dr. Patricia Mozzicato Chief Medical Officer, MedDRA Maintenance & Support Services Reconcile Differences in Technical Regulatory Organization (MSSO), USA Requirements Session Chairs Mr. Gary M. Gensinger 12:30 pm–1:30 pm lUNCh Break Deputy Director, Office of Business Informatics, Center for Drug Evaluation and Research (CDER), Food and Drug Administration 1:30 pm–3:00 pm Plenary Session (FDA), USA Mr. John W. Kiser Good Regulatory Practices, Including Assessment Senior Director, Global Pharmaceutical Regulatory Affairs, Report, Efficient Use of Certificate of Pharmaceutical Submission Operations & Strategic Initiatives, Product (CPPs) and Transparency Abbott Laboratories, USA Session Chairs The Advantages and Challenges of Electronic Dr. Megan Keaney Regulatory Submissions in eCTD and Non-eCTD Principal Medical Adviser, Therapeutic Goods Administration (TGA), Electronic Submissions (NeeS) Formats – Australia An Industry Perspective Dr. Yves Juillet Mr. John W. Kiser DIA President Elect Senior Director, Global Pharmaceutical Regulatory Affairs, Senior Advisor, LEEM, France, (APEC Harmonization Submission Operations & Strategic Initiatives, Abbott Center Advisory Board Member) Laboratories, USA Good Regulatory Practices: Do We Have a Common Benefits to Implementing eCTD – A Regulatory Understanding? Perspective Dr. Yoshiaki Uyama Mr. Gary M. Gensinger Director, Division of Regulatory Research, Office of Regulatory Deputy Director, Office of Business Informatics, Center for Science, Pharmaceuticals and Medical Devices Agency Drug Evaluation and Research (CDER), Food and Drug (PMDA), Japan Administration (FDA), USA Opportunities for Industry to Partner with Drug Practical Use and Challenges Faced – Regulatory Authorities (DRAs) to Further Good An Asian Regulator Perspective Regulatory Practices Ms. Jalene Poh Dr. Romi Singh Regulatory Consultant, Pharmaceuticals & Biologics Branch, Executive Director, Global Regulatory Affairs & Safety, Pre-Marketing Division, Health Products Regulation Group, Amgen, USA Health Sciences Authority (HSA), Singapore Efficient Use of CPPs Dr. Lembit Rägo 10:00 am-10:30 am Refreshment Break Coordinator, Quality Assurance & Safety for Medicines (QSM), Essential Medicines Pharmaceutical Policies Department, World Health Organization (WHO), Switzerland (WHO ICH SC and 10:30 am-12:30 pm plenary Session GCG Observer) Pharmacovigilance: How Do Regulatory Agencies and Industry Work Together to Protect Patients? 3:00 pm-3:10 pm Closing Remarks by Program Committee Chairs Session Chairs Dr. Suzette Henares-Lazo Acting Director IV, Food and Drug Administration (FDA), 3:30 pm-5:30 pm GCp site tour (optional) Philippines Korea National Enterprise for Clinical Trials Dr. Paul Eisenberg (Seoul National University Hospital) Senior Vice President, Global Regulatory Affairs and Safety, For International Participants Only Amgen, USA Current Status and New Directions for Pharmacovigilance in Korea Dr. Joungwon Oh Deputy Director, Pharmaceutical Safety Bureau, Korea Food and Drug Administration (KFDA), Republic of Korea Integrating Risk Management into Global Drug Development – Opportunities and Challenges Dr. Paul Eisenberg Senior Vice President, Global Regulatory Affairs and Safety, Amgen, USA Post-Marketed Surveillance – A Shared Responsibility Dr. Rebecca Wang Head of Drug Safety Operation, Regional Center for Asia Pacific, Roche, P.R. China 6

Welcome Reception

Tuesday, 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 Tour Korea 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 Ballroom Parallel Track 1 - Grand Ballroom 1 Parallel Track 2 - Grand Ballroom 3 Parallel Track 3 - Flamingo

The sessions will be held in the above meeting rooms for the entire conference. Committee/ADVISORY MEMBERS 7

PROGRAM committee Chair Chang Won Park André W. Broekmans Deputy Director, Drug Approval and Review Management Division, Korea Food and Drug Administration (KFDA), Vice President, Most of World Regulatory Policy & Regulatory Republic of Korea Affairs, MSD, The Netherlands (ICH SC and GCG Member) Kui Lea Park Director, Center for Drug Safety Assistance Korea Food and PROGRAM Committee Co-Chair Drug Administration (KFDA), Republic of Korea Sun Hee Lee Jae-Gook Shin Director, Drug Evaluation Department Professor & Director Korea Food and Drug Administration (KFDA), Department of Clinical Pharmacology & Clinical Trial Center Republic of Korea (ICH GCG Member) Inje University Busan Paik Hospital, Republic of Korea Romi Singh PROGRAM COMMITTEE MEMBERS Executive Director Laetitia Bigger Global Regulatory Affairs & Safety Amgen, USA Manager, Regulatory & Scientific Affairs IFPMA, Switzerland Jiwung Son Patrick K. Brady Hanmi Pharmaceuticals, Republic of Korea Scientific & Regulatory Affairs Soo Kyung Suh PhRMA, USA Deputy Director, Advanced Therapy Products Division Korea Julie Dennis Food and Drug Administration (KFDA), Republic of Korea Senior Director, Worldwide Regulatory Strategy, Adrian Waterson Emerging Markets, Pfizer, UK Asia Regulatory Director, AstraZeneca, UK Weon Do Tae Moo Yoo Head of Regulatory Affairs & Market Access sanofi-aventis, Director, Drug Approval and Review Management Division, Republic of Korea Korea Food and Drug Administration (KFDA), Republic of Ziqun Han Korea Manager, Regulatory Policy & Intelligence Abbott Laboratories, UK ADVISORY COMMITTEE Tiffany Hoang Regional Senior Manager Yves Juillet Global Regulatory Strategy, Policy & Safety - Asia Pacific DIA President Elect MSD, Singapore Senior Advisor, LEEM, France, (APEC Harmonization In-Jin Jang Center Advisory Board Member) Seoul National University, Republic of Korea Tatsuo Kurokawa Yuppadee Javroongrit Chiba University Graduate School of Pharmaceutical Assistant Director and Head of International Sciences, Japan Affairs and IND Section Drug Control Division, Thai FDA, Justina A. Molzon Thailand, (ICH GCG Observer for ASEAN, Co-Chair of ASEAN Associate Director, International Programs, Center for ACCSQ PPWG) Drug Evaluation and Research (CDER), Food and Drug Tae-Gyun Kim Administration (FDA), USA (ICH SC and GCG Member, Deputy Director, Center for Drug Development Assistance Chair of the APEC RHSC Subcommittee on Training) Korea Food and Drug Administration (KFDA), Republic of Lembit Rägo Korea Coordinator, Quality Assurance & Safety for Medicines Yil-Seob Lee (QSM) World Health Organization (WHO), Switzerland, Director, Medical & Regulatory Affairs, (WHO ICH SC and GCG Observer) GlaxoSmithKline, Republic of Korea Sang-Goo Shin John C.W. Lim President Chief Executive Officer, Health Sciences Authority (HSA), KoNECT – Korea National Enterprise for Clinical Trials Singapore Republic of Korea Christina Lim Larisa Nagra Singh Group Director, Health Products Regulation Group Health Senior Director, Clinical Operations Asia Pacific, ICON Sciences Authority (HSA), Singapore, (ICH GCG Member) Clinical Research, India Arun Mishra Ling Su Director, Global Regulatory Affairs GlaxoSmithKline, UK Senior Vice President and Head of Development Greater Seiji Miyazawa China Novartis, P.R. China Director, International Affairs JPMA, Japan Mike Ward Odette Morin Manager, International Program Division, Health Products Director, Regulatory and Scientific Affairs IFPMA, Switzerland and Food Branch, Health Canada, Canada, (ICH SC and (Director of ICH Secretariat, ICH SC and GCG Member) GCG Member, Chair of the APEC RHSC) PARTICIPANTS ALPHABETIZED BY LAST NAME 8

Accorsi, Stefano Bolam, Ian Cheon, Chunhoo Choi, JaeYoung Chiesi Farmaceutici S.p.A Gilead Sciences International Kyung Hee University Berna Biotech Korea Corp. Italy Limited Republic of Korea Republic of Korea United Kingdom Ahn, Mi Ji Chern, Herng-Der Choi, Jongtae MSD Korea Broekmans, Andre Center for Drug Evaluation Korea Republic of Korea MSD Chinese Taipei Republic of Korea Netherlands An, Hyun Ju Cheung, Rebecca Choi, A Handok Pharmaceuticals Co., Ltd. bte Hj Md Jaafar, Aminah Ferring Pharmaceuticals Ltd. LGLS Republic of Korea Ministry of Health, Republic of Korea Brunei Darussalam Ando, Yuki Chiu, Ammy Choi, Kihwan Pharmaceuticals and Medical Cai, Jane Taiwan Daiichisankyo Ltd. KFDA Devices Agency DIA Taiwan Republic of Korea Japan China Cho, Hea-Kyoung Choi, Kyungae Ang, Eileen Cai, Ya Bristol-Myers Squibb Company CJ Jeiljedang GlaxoSmithkline Pte Ltd GlaxoSmithKline Pte Ltd Republic of Korea Republic of Korea Singapore Singapore Choi, Paul HS. Cho, Hijung SilverNet News Aragishi, Atsushi Chae, Ree Novartis Korea Republic of Korea Dainippon Sumitomo Pharma Harlan Korea Laboratories, Co., Ltd. Republic of Korea Japan Republic of Korea Choi, Rachel Cho, Jaehoon KHIDI Bae, SoYeon Chahal, Bindoo Celltrion Republic of Korea Celltrion Besins Healthcare S.A. Republic of Korea Republic of Korea Thailand Choi, Yoon Young Cho, Sun Hee MSD Korea Bae, Yohan Chan, Agnes Eli Lilly Republic of Korea BMS Health Sciences Authority Republic of Korea Republic of Korea Singapore Choi, Young Eun Cho, YeKyung Korea Bae, Yoon Ju Chan, Sabrina Bayer Korea Ltd Republic of Korea LG Life Sciences The Hong Kong Association of Republic of Korea Republic of Korea the Pharmaceutical Industry Choi, Yun China Cho, YeongMi Green Cross Corp. Bae, Young-Kyung Genzyme Korea Republic of Korea CJ Cheiljedang Chang, Grace Republic of Korea Republic of Korea RDPAC Choi, Yun Hwa China Cho, YoonJoo Lilly Korea Bae, Go-Oon AstraZeneca Republic of Korea C&C Research Laboratories Chang, Jianqing Republic of Korea Republic of Korea RDPAC Chon, Soo Ah China Cho, YoungHoon Invida Korea Limited Baek, Sun Hye Samyang Corporatinon Republic of Korea Bayer Korea Chang, Mikyung Republic of Korea Republic of Korea Bayer Korea Ltd. Chong, Sannie Republic of Korea Cho, YoungJoo Health Sciences Authority Bahn, Joonwoo WhanIn Pharm. Singapore AstraZeneca Korea Chang, Vicky Republic of Korea Republic of Korea Astellas Pharma Taiwan, Inc. Chow, Lilian Taiwan Choi, Eun Jung Lundbeck Singapore Pte Ltd Baik, Jongheebaik UCB Korea Singapore Ilyang Pharmaceutical Cc., Ltd. Changvisommid, Somthavy Republic of Korea Chu, Karen Republic of Korea Food and Drug Department, PAREXEL International Ministry of Health, Lao PDR Choi, Eun Young Taiwan Baik, Sang Hyun Lao PDR Handok Pharmaceuticals Co., Ltd. Chong Kun Dang Bio Corp. Republic of Korea Chu, Keeltack Che, Minhee Republic of Korea Sewoncellontech Co., Ltd. Choi, Heijin Novartis Republic of Korea Bang, Hyeryun Republic of Korea Astellas Pharma Korea Inc. Abbott Korea Republic of Korea Chu, Sandra Republic of Korea Chen, Decent Abbott Laboratories Service Bristol-Myers Squibb Company Choi, Hye Jin Corp. Taiwan Branch Bang, Joon Taiwan ICON Clinical Research Korea Ltd. Taiwan Sanofi Pasteur Republic of Korea Republic of Korea Chen, Jennifer Chun, Yunok RDPAC Choi, Hyunil Sanofi Pasteur Bigger, Laetitia China SAM Research Institute for Cell Republic of Korea IFPMA and Gene Therapy Switzerland Cheng Leng, Chan Republic of Korea Chun, Yura Health Sciences Authority Novartis Korea Ltd. Singapore Republic of Korea PARTICIPANTS ALPHABETIZED BY LAST NAME 9

Chung, Alicia Ha, Eunhee Hong, AhLim Imuta, Kaoru PAREXEL International Novartis Korea MSD Korea Kyowa Hakko Kirin Taiwan Republic of Korea Republic of Korea Japan

Chung, Seo Ha, Hyunji Hong, Ji-Young Jaehong, Kim Greencross Bayer Korea Wyeth Korea C&R Research Inc. Republic of Korea Republic of Korea Republic of Korea Republic of Korea

Daniels, Moira Ha, Ji Won Hong, Sunghee Jae-Hoon, Cho AstraZeneca ICON Clinical Research Korea Handok Pharmaceutical Greencross United Kingdom Republic of Korea Republic of Korea Republic of Korea

Davidson, Alistair Ha, Jinny Hong, SungIn Jair, Rosni Asia-Pacific, PPD KHIDI RSP Research Inc. Department of Pharmaceutical United Kingdom Republic of Korea Republic of Korea Services, Ministry of Health Brunei Darussalam Dennis, Julie Ha, Juyeon Hope, Phelps Pfizer Ltd Bausch + Lomb Kellen Meetings Jang, In-Jin United States Republic of Korea United States SNUH Republic of Korea Do, Weon Hahn, Bernard Hu, He sanofi-aventis Genentech Hangzhou MSD Pharmaceutical Jang, Kyung Won Republic of Korea United States Co.,Ltd.Beijing Branch KHIDI China Republic of Korea Eisenberg, Paul Hall, Patricia Amgen PharmaNet Ltd. Huang, Yenling Jang, Soojung United States United Kingdom Eli Lilly and Company Servier Korea Taiwan Republic of Korea Eom, Seong Sil Han, HyeSeung Astellas Korea Berna Biotech Korea Hwang, Il-Hyung Javroongrit, Yuppadee Republic of Korea Republic of Korea Daiichisankyo Korea Food and Drug Administration, Republic of Korea Ministry of Public Health Eom, Taekyoung Han, Sol Thailand Bayer Korea GlaxoSmithKline Korea Hwang, Juha Republic of Korea Republic of Korea Bayer Korea Jeon, Hyewon Republic of Korea Baxter France, Georges Han, Ziqun Republic of Korea Pfizer Abbott Laboratories Hwang, Woo-Jin United Kingdom United Kingdom Pfizer Pharmaceuticals Korea Jeon, Min- Limited Samyang Corporation Fujimaru, Kiyoshi Heang, Sar Kuy Republic of Korea Republic of Korea Niphix KK Bureau of Drug and Cosmetic Japan Registration, Ministry of Health HyeSun, Lim Jeon, Sanghee Cambodia Magistella Daewoong, Pharmaceutical Co., Ltd. Fukuyama, Hidenori Republic of Korea Republic of Korea Shionogi & Co., Ltd Henares-Lazo, Suzette Japan Phillippines FDA Hyun, Chang Jun Jeong, Seong-Won Philippines CJ Cheiljaedang Sanofi Pasteur Furuya, Yoshikata Republic of Korea Republic of Korea MSD K.K. Heng, Christine Japan Celgene Pte Ltd Hyun, KyongHwa Jeong, Yeonsim Singapore Lundbeck Korea Co., Ltd. AstraZeneca Korea Gao, Xinjian Republic of Korea Republic of Korea Astellas Pharma China Inc. Hengrasme, Boosba China Baker & McKenzie Hyun, Ye Jin Ji, Hyi-Jeong Thailand Genzyme Korea LGLS, Ltd. GAO, Yan Republic of Korea Republic of Korea AstraZeneca China,Inc. Heo, Eunkyung China C&R Research Inc. Hyun Nam, Ryu Jieun, Lee Republic of Korea LG Life Sciences UCB Korea Co.,Inc Gensinger, Gary Republic of Korea Republic of Korea Food and Drug Administration Hirai, United States Pfizer Japan Inc. Hyun Sook, Kim Jihyoun, Lim Japan CJ Jeiljedang Pharmaceutical BU Servier Korea Gi, Geun Yeong Republic of Korea Republic of Korea KHIDI Hiyama, Yukio Republic of Korea National Institute of Health Hyun-Suk, Min Jinhee, Kim Sciences Greencross Servier Korea Guo, Wenyu Japan Republic of Korea Republic of Korea AstraZeneca Pharmaceutial Company Hoang, Tiffany Imatsu, Hozui Jinju, Li China MSD ASKLEP Inc. State Food and Drug Singapore Japan Administration (SFDA) China PARTICIPANTS ALPHABETIZED BY LAST NAME 10

Jo, Taeyoun Kang, Hyo-Seon Kim, Chin Kim, Hyesung MSD Korea AstraZececa Korea Chong Kun Dang Samil Pharm.Co.,Ltd. Republic of Korea Republic of Korea Pharmaceutical Corp. Republic of Korea Republic of Korea Joo, Sunghyun Kang, Hyunju Kim, Hyun Jin Berna Biotech Korea Corp. Roche Korea/Regulatory Affairs Kim, Dong Eon MSD Korea Republic of Korea Republic of Korea Ilyang Pharmaceutical Co., Ltd. Republic of Korea Republic of Korea Joos, Angelika Kang, Jaw-Jou Kim, Hyung Shin Merck Sharp & Dohme Taiwan Food & Drug Kim, DongMin LG Life Science (Europe), Inc. Administration Celltrion, Inc. Republic of Korea Belgium Taiwan Republic of Korea Kim, Hyunji Ju, In Sook Kang, Seongsik Kim, Eric Wyeth Korea KRPIA MSD Korea KHIDI Republic of Korea Republic of Korea Republic of Korea Republic of Korea Kim, HyunJin Juillet, Yves Kang, Sylvia Kim, EuiJin Invida Korea Limited LEEM Parexel Korea Celltrion, Inc. Republic of Korea France Republic of Korea Republic of Korea Kim, Hyunjo Jun, Dong-ho Kaur, Kirpal Kim, Eun Ah Sahmyook University Whanin Pharm Co., Ltd. Bristol-Myers Squibb Australia LSK Global Pharma Services Republic of Korea Republic of Korea Australia Republic of Korea Kim, In Hye Jung, Eun-Mi Kearney, Megan Kim, Eun-gyung Korea OIAA Co., Ltd Pfizer Korea Therapeutic Goods Inha University Hospital Republic of Korea Republic of Korea Administration (TGA) Republic of Korea Australia Kim, In-Bum Jung, Hyung-Jin Kim, Eunjung Korean Research-based Pfizer Korea Keitel, Susanne Allergan Korea Pharmaceutical Industry Republic of Korea EDQM Republic of Korea Association (KRPIA) France Republic of Korea Jung, Jihye Kim, Eunkyung Korea Otsuka International Asia Keok, Christina Novartis Kim, Inhyang Arab Bristol-Myers Squibb Republic of Korea C&R Research, Inc. Republic of Korea Pte Ltd Republic of Korea Singapore Kim, Eunyoung Jung, Mijin Samil Pharm. Co., Ltd. Kim, JaeWoo Novartis Korea Kikuchi, Yota Republic of Korea Asan Medical Center Republic of Korea sanofi-aventis Republic of Korea Japan Kim, Go Eun Jung, Minjung Celgene Corp. Kim, Jayoung UCB Korea Pharmaceuticals Ltd. Kikuchi, Yuko Republic of Korea GSK Republic of Korea Eisai Co., Ltd. Republic of Korea Japan Kim, Hanna Jung, YeiLi C&R Research, Inc. Kim, Jeeyoung LG Life Sciences,Ltd. Kim, Ahran Republic of Korea KHIDI Republic of Korea Boehringer Ingelheim Korea Ltd. Republic of Korea Republic of Korea Kim, Heeha Jung, Yoomi KPMA Kim, Ji Hyun FreseniusKabi Kim, Ah-young Republic of Korea MSD Korea Republic of Korea Fresenius Kabi Korea Republic of Korea Republic of Korea Kim, Heejin Kang, Boseong LSK Global PS Kim, Jieun Kuhnil Pharm Kim, Boyeon Republic of Korea Pfizer Republic of Korea Korea Food & Drug Republic of Korea Administration Kim, HeeKyung Kang, Bu Im Republic of Korea Samsung Electronics Kim, Jihye sanofi-aventis Korea Republic of Korea UCB Korea Republic of Korea Kim, Boyoung Republic of Korea Bausch + Lomb Kim, Ho Soon Kang, Changmo Republic of Korea Dongbu Hannong Kim, Ji-Hyun LG Life Sciences Republic of Korea Ilyang Pharmaceutical Co., Ltd. Republic of Korea Kim, Bup Wan Republic of Korea KHIDI Kim, HongJoo Kang, Dae Joon Republic of Korea Berna Biotech Korea Corp. Kim, Jisoo CKD Bio Corp. Republic of Korea Samyang Corporation Republic of Korea Kim, Byungjin Republic of Korea R&P Korea Kim, Hyejin Kang, Hyerim Republic of Korea Novartis Korea Kim, Ji-Yeon Korea UCB Co., LTD Kim, Changhee Republic of Korea GSK Republic of Korea UCB Korea Republic of Korea Republic of Korea PARTICIPANTS ALPHABETIZED BY LAST NAME 11

Kim, Jiyoon Kim, Simon Kim, Zisoo Lebrilla, Crisostomo Novartis Korea Jeilkirin Quintiles Amgen Republic of Korea Republic of Korea Republic of Korea United States

Kim, Jong Hag Kim, Soo-Kwan Kiser, John Lee, Anna CKD BiO corp. Kolmar Korea Abbott Laboratories Hospital Authority Republic of Korea Republic of Korea United States Hong Kong

Kim, Kaeun Kim, Soyoung Ko, Suyeon Lee, Annette Bausch + Lomb UCB Korea Harlan Johnson & Johnson Republic of Korea Republic of Korea Republic of Korea Singapore

Kim, Kyong Sun Kim, Sun Ahe Ko, Yunjung Lee, Chang Hee Eisai Korea Inc. LG Life Sciences, Ltd Samjin Green Cross Corp. Republic of Korea Republic of Korea Republic of Korea Republic of Korea

Kim, Kyungsoo Kim, Sung Ho Kobayashi, Ken Lee, Cho Rong GE Healthcare GlaxoSmithKline Korea Johnson & Johnson International Starcom Republic of Korea Republic of Korea Japan Republic of Korea

Kim, Mikyung Kim, Sung Il Koh, A Ra Lee, Choo Ai Abbott LG Life Sciences, Ltd Eisai Korea Inc. Health Sciences Authority Republic of Korea Republic of Korea Republic of Korea Singapore

Kim, Min Young Kim, Taeeun Kondo, Shuji Lee, Chounho PAREXEL Ltd. Roche Korea Pharmaceutical Research and Dongchun Media Co. Republic of Korea Republic of Korea Manufacturers of America Republic of Korea Japan Kim, Min-Young Kim, Tae-Gyun Lee, Do Youn Pfizer Korea KFDA Koo, Hyejin CJ CheilJedang Co. Republic of Korea Republic of Korea GSK Republic of Korea Republic of Korea Kim, MooSoo Kim, TaeHyun Lee, EunSun Sanofi Pasteur Byaerhealthcare Koo, Jihyun Baxter Incorporated Republic of Korea Republic of Korea Jeilkirin Republic of Korea Republic of Korea Kim, Myounghee Kim, Wansoo Lee, Hankyu ICON Clinical Research Korea Boehringer Ingelheim Korea Ltd. Krause, Ryoko GlaxoSmithKline Republic of Korea Republic of Korea IFPMA Republic of Korea Switzerland Kim, NaEun Kim, Yanghee Lee, Hwa-Young BayerHealthCare C&C Research Labs Kubic, Thomas Pfizer Pharmaceuticals Korea Ltd., Republic of Korea Republic of Korea Pharmaceutical Security Institute Republic of Korea United States Kim, Okyoung Kim, Yeongji Lee, Hye Jung Novartis Korea Chong Kun Dang Pharmaceutical Kukrety, Arvind Hopkins Bio Research Center, Inc. Republic of Korea Corp. Government of India Republic of Korea Republic of Korea India Kim, Sabin Lee, Hyunae MSD Korea Kim, YeRim Kumagai, Susumu Bayer Korea Ltd. Republic of Korea Bayer Korea Limited Mitsui & Co., Ltd. Medical Republic of Korea Republic of Korea Healthcare Business Division Kim, Sam Sik Japan Lee, JaeWook LG Life Science Kim, Yoon Jeon GE Healthcare AS Republic of Korea MSD Korea Kustantinah, Dra Republic of Korea Republic of Korea National Agency for Food Kim, Sei-Eun and Drug Control Lee, Jaewook Hanmi Pharm. Co. Ltd. Kim, Yooni Indonesia PAREXEL Republic of Korea PRA Korea Republic of Korea Republic of Korea Kwon, Hyonsoo Kim, SeongHyeon KRPIA Lee, Jeemin JW Pharmaceutical Kim, Youhwa Republic of Korea Lilly Korea Ltd Republic of Korea sanofi-aventis Korea Republic of Korea Republic of Korea Kwon, Inhye Kim, Seoyoung Novartis Korea Lee, Jeong Sang sanofi-aventis Korea Kim, Yun Sun Republic of Korea Seoul National University Republic of Korea Novo Nordisk Pharma Korea Boramae Hospital Republic of Korea Kwong, Kwok Wai Heston Republic of Korea Kim, Seung Hee Department of Health, HKSARG NIFDS Kim, Hong Kong Lee, Jeong-A Republic of Korea C&R Research, Inc. Merck Limited Korea Republic of Korea Kyounghee, Seo Republic of Korea Kim, ShinKeol Servier Korea Lilly Korea Republic of Korea Republic of Korea PARTICIPANTS ALPHABETIZED BY LAST NAME 12

Lee, Ji Yeon Lee, Seunghun Lertamphainont, Nongnooth Lo, Shirley Allergan Korea Bayer HealthCare Bristol-Myers Squibb Pharma Ltd. Janssen Cilag Asia Pacific Republic of Korea Pharmaceuticals Thailand Singapore Republic of Korea Lee, Jiyeon Li, Andy Low, Chee Kim Samil Allergan Lee, Shinwon Pfizer Research GlaxoSmithKline Pte Ltd Republic of Korea Pfizer & Development Co., Ltd Singapore Republic of Korea China Lee, JiYoung Lu, Yuzhen MSD Korea Lee, Si-Nae Li, Hua Shanghai Roche Republic of Korea BMS Korea UCB Pharmaceuticals Ltd. Republic of Korea China China Lee, Jooyun Bayer Lee, So Ra Li, Jingyi Ma, Helena Republic of Korea NovoNordisk Korea AstraZeneca China, Inc. Beijing Novartis Pharma Ltd. Republic of Korea China China Lee, Ju Ha KHIDI Lee, So-Jeong Li, Xing Maeda, Akio Republic of Korea GlaxoSmithKline sanofi-aventis Abbott Japan Co., Ltd. Republic of Korea China Japan Lee, Ju Hyeon MSD Korea Lee, Sophia Li, Xuesong Maryati, Herlys Republic of Korea Roche Korea LEO Pharma Glaxo Wellcome Indonesia Republic of Korea China Indonesia Lee, Jung Eun GE Healthcare AS Korea Branch Lee, Sun Hee Lim, Christina Masuda, Koji Republic of Korea KFDA Health Sciences Authority Chugai China Republic of Korea Singapore China Lee, Jung Eun KoNECT Lee, Taehyun Lim, Eun Ji Meng, Qian Republic of Korea MSD Korea Ltd. Pfizer Roche Product Development Republic of Korea Republic of Korea in Asia Pacific Lee, Jungwon China UCB Korea Lee, William Lim, JI-Sun Republic of Korea Quintiles Pte. Ltd. Yonsei University Miki, Satoshi Singapore Republic of Korea UCB Japan Co., Ltd. Lee, Kyongjin Japan MSD Lee, Won-Sik Lim, John Republic of Korea Pfizer Pharmaceuticals Korea Ltd. Health Sciences Authority Min, Hyang Won (Harriet) Republic of Korea Singapore UCB Korea Ltd Lee, Kyoung-Chun Republic of Korea GSK Korea Lee, Yeong Mi Lim, Jonathan Republic of Korea KRPIA KHIDI Miok, Republic of Korea Republic of Korea Dasan Medichem Lee, Kyung Rim Republic of Korea Lilly Korea Lee, Yeong Mi Lim, Junghyun Republic of Korea KRPIA Santen Korea Mishra, Arun Republic of Korea Republic of Korea GlaxoSmithKline Lee, Mihyun United Kingdom Korea Otsuka Pharmaceutical Lee, Yeong-min Lim, Min-Jung Republic of Korea Pfizer Korea GSK Korea Miyazawa, Seiji Republic of Korea Republic of Korea JPMA Lee, Minah Japan Lundbeck Korea Lee, Yeonkyung Lim, Yunni Republic of Korea sonofi-aventis Korea Roche Korea Miyeop, Lee Republic of Korea Republic of Korea CJ CheilJedang Corporation Lee, Mira Republic of Korea LG Life Sciences Lee, YoonYi Lim, Hyun Chul Republic of Korea Astellas Pharma Korea Inc. Dasan Medichem Co., Ltd. Moah, Son Republic of Korea Republic of Korea JW Pharmaceutical Lee, Na-Young Republic of Korea PharmaNet Korea Limited Lee, Young-sook Lin, Yang Republic of Korea BMS Pharmaceutical Korea Singapore Radiopharmaceuticals Molzon, Justina Limited. Singapore Center for Drug Evaluation and Lee, Ron-Wai Republic of Korea Research/ USFDA Amgen Lin, Yu-Ju United States United States Lee, Yujin Astellas Pharma Taiwan, Inc. Abbott Korea Taiwan Monk, Deborah Lee, Seungdeok Republic of Korea Medicines Australia Dongguk University Lo, Man Wah Australia Republic of Korea Lee, Yunkyung Genzyme MSD KOREA LTD. Hong Kong Moon, Noomi Republic of Korea KRPIA Republic of Korea PARTICIPANTS ALPHABETIZED BY LAST NAME 13

Morénas, Jacques Oh, Ji Young Park, Hye Jung Park, Sangmin The French Health Products Quintiles Korea CJ Cheiljedang Corp. C & R Research Safety Agency (AFSSAPS) Republic of Korea Republic of Korea Republic of Korea France Oh, Joungwon Park, HyeYoung Park, SeJin Morin, Odette Korea Food and Drug CELLTRION,Inc C&C Clinical Lab IFPMA Administration (KFDA) Republic of Korea Republic of Korea Switzerland Republic of Korea Park, Hyo Eun Park, Shinmyun Mozzicato, Patricia Oh, Kyu-Ho LG Life Science Celltrion, Inc. MedDRA MSSO LSK Global Pharma Services Republic of Korea Republic of Korea United States Republic of Korea Park, Hyonam Park, Shin-young Mulholland, Leyna Oh, Sae Won Merck Korea Korea Institute of Toxicology F Hoffman-La Roche Eli Lilly Republic of Korea Republic of Korea Japan Republic of Korea Park, HyunJu Park, So-Yeon Mune, JuneSik Okayasu, Ayako Abbott Korea Celgene Korea Baxter Astrazeneca KK Republic of Korea Republic of Korea Republic of Korea Japan Park, Jae Eun Park, Soyoung Murao, Noriaki Okuda, Teruyoshi Baxter Bayer Korea Ltd Merz Pharmaceuticals GmbH Niphix KK Republic of Korea Republic of Korea Japan Japan Park, Jae Youn Park, Yumi Music, Tamara Ono, Teruaki JW Holdings/ JW Holdgins IFPMA C&C Research Laboratories Global Business Division Republic of Korea Switzerland Korea (DPR) Republic of Korea Peiravian, Farzad Myint, Thiri Tun Ono, Yoshihiko Park, Jin-Young Qazvin University of Medical Food and Drug Administration, Pfizer Japan Inc. GSK Sciences Ministry of Health, Myanmar Japan Republic of Korea Iran

Nakamura, Hidefumi Pang, Ka Yan Ada Park, Joan Picker, Jean-luc National Center for Child Health Fresenius Kabi Asia Pacific KHIDI Servier and Development Industry Hong Kong Republic of Korea Republic of Korea Japan Park, Alex Kyunghwa Park, Jongeun Poh, Jalene Nam, Hyukjun Allergan Korea MSD Health Sciences Authority MEDIPOST Co., Ltd. Republic of Korea Republic of Korea Singapore Republic of Korea Park, Beomsoo Park, Junghee Pradhan, AK Nam, Kyuyeol Dong-A Pharmaceutical Co. Ltd MSD Korea LTD Government of India Korea United Pharm. Inc. Republic of Korea Republic of Korea India Republic of Korea Park, Bojung Park, Kui Lea Qiu, Yihong Nam, Moonsuk Santen Korea Korea Food and Drug Abbott Laboratories INHA University Hospital Republic of Korea Administration (KFDA) United States Republic of Korea Republic of Korea Park, Byung-Ju Quoc Cuong, Truong Nam Gung, Suk Republic of Korea Park, Kyehyun Drug Administration of VietNam, ADM Korea KRPIA Ministry of Health, Vietnam Republic of Korea Park, Chae Young Republic of Korea Johnson and Johnson Medical Rägo, Lembit Namgung, Yun Jung Korea Park, Mi Suk WHO Roche Korea Co., Ltd. Republic of Korea Korea UCB Co., LTD Switzerland Republic of Korea Republic of Korea Park, Chang-Won Rahman, Eishah A. Nasr, Moheb Food and Drug Administration Park, Min Soo Ministry of Health Food and Drug Administration Republic of Korea Yonsei University Malaysia United States Republic of Korea Park, Gang Yong Ramirez, Cinthya Noda, Kouichi KHIDI Park, MyungHa IFPMA Mochida Pharmaceutical Co. Ltd. Republic of Korea GSK Switzerland Japan Republic of Korea Park, Hee Young Ramkishan, Ajmeer Noh, Heejung KFDA Park, Neunggyu(Paul) CDSCO, Government of India Baxter Republic of Korea CMIC KOREA India Republic of Korea Republic of Korea Park, Hwan Guk Rau, Irene Noh, Yun Hong KHIDI Park, Sang Mi GlaxoSmithKline KFDA Republic of Korea Actelion Taiwan Republic of Korea Republic of Korea PARTICIPANTS ALPHABETIZED BY LAST NAME 14

Remaut, Anne-Cécile Seob-Lee, Yil Shinozuka, Hideo Sumi, Lee Science Union GlaxoSmithKline Kyowa Hakko Kirin Co.,Ltd Dongwha Pharm. France Republic of Korea Japan Republic of Korea

Ren, Jannie Seol, Choon Keun Sia, Kin Tong Sun, Peng Pfizer (China) Research & CKD Bio Corporation LEO Pharma Asia Pte Ltd AstraZeneca Pharmaceutical Development Co., Ltd Republic of Korea Singapore Co.,Ltd. China China Seol, Jaeyoon Simanjuntak, Parulian Rhee, Jiwon Novartis Korea Ltd. Internationa Pharmaceutical Sung, Hye-young Otsuka International Asia Arab Republic of Korea Manufacturers Group (IPMG) Asan Medical Center Republic of Korea Indonesia Republic of Korea Seong, Yoonju Rhee, Soo-Jin Boehringer Ingelheim Korea Ltd. Singh, Romi SungMo, Kang PPD Republic of Korea Amgen Dasan Medichem Co., Ltd. Republic of Korea United States Republic of Korea Shen, Yanyun Rhim, Hyou Young Roche China Slamet, M.Sc, Lucky S. Tacandong, Nazarita Janssen Korea China National Agency for Drug and Food and Drug Administration Republic of Korea Food Control Philippines Shim, Jae Myung Indonesia Richardson, Peter Celgene Korea Takaki, Koji European Medicines Agency Republic of Korea Sohn, Ji Yeon Chugai Pharmaceutical Co., Ltd. (EMA) Astellas Korea Japan United Kingdom Shim, Juyoun Republic of Korea Korea OIAA, Tan, Adeline Robinson, Lisa T Republic of Korea Sohn, Kyu Been Allergan Singapore Pte Ltd Kellen Meetings Pfizer Singapore United States Shim, Soyoun Republic of Korea Genzyme Korea Tan, Emily Roh, Seungah Republic of Korea Son, Kyunghwa PharmaNet Pte Ltd CJ CheilJedang Corp. Isuabxis Singapore Republic of Korea Shimizu, Yoko Republic of Korea Takeda Pharmaceutical Company Tanaka, Riho Roongadulpisan, Pintip Limited Song, Rok Mitsui & Co., Ltd. Medical Thai Meiji Pharmaceutical Co., Ltd. Japan GlaxoSmithKline Healthcare Business Division Thailand Republic of Korea Japan Shin, Dong Yeop Routhier, François-Xavier LG Life Science,Ltd. Song, Sang Yup Tay, Kee Wee sanofi-aventis R&D Republic of Korea NovoNordisk Korea Abbott Laboratories (Singapore) France Republic of Korea Pte Ltd Shin, Dong-Hoon Singapore Rozycki, Michael Keimyung University Dongsan Song, Soohyeon Bayer Medical Center Korea OIAA Temeck, Jean China Republic of Korea Republic of Korea Food and Drug Administration United States Ruiz de Erenchun, Fermin Shin, Eunjeong Song, Yurn-Su Hoffmann-La Roche Ltd Wyeth Korea Boehringer-Ingelheim Korea Thompson, Elizabeth Switzerland Republic of Korea Republic of Korea Bayer Australia Ltd. Australia Sang Cheol, Shin Shin, Heekang Soo Kiang, Cheah Green Cross Bayer Korea PharmaNet Pte Ltd Totsuka, Hitoshi Republic of Korea Republic of Korea Singapore UCB Japan Co.,Ltd. Japan Santoso, Lucia Shin, Mihye Soon, Swee Sung Experimental Therapeutics Centre Innopath Intl. Inc. Singapore Clinical Research Tsay, Rick Singapore Republic of Korea Institute MSD Japan Singapore Japan Seerangam, Selvaraja S. Shin, Sang Goo National Pharmaceutical Control KoNECT Suh, Brian Tseng, Eric Bureau, Ministry of Health Republic of Korea KHIDI Servier Malaysia Republic of Korea Taiwan Shin, Sang Min Suh, Inhoo Tsim, Clarice Sengaloundeth, Sivong LG Life Sciences Novotech Asia Korea Fresenius Kabi Asia Pacific Ltd Food and Drug Department, Republic of Korea Republic of Korea Hong Kong Ministry of Health, Lao PDR Lao PDR Shin, Sang-Goo Suh, Seungwon Tsuchiya, Etsuko Seoul National University College ISU ABXIS CO.,LTD Eisai Co., Ltd., Seo, Jeongeun of Medicine and Hospital Republic of Korea Japan MSD Korea Republic of Korea Republic of Korea Suk, Hwa Ok Uditananda, Malinee Shin, Zisoon Sarangmal International Volunteer DKSH Limited Seo, KwangSeok Novo Nordisk Pharma Korea. Ltd. Republic of Korea Thailand Dong-A Pharmaceutical Republic of Korea Republic of Korea PARTICIPANTS ALPHABETIZED BY LAST NAME 15

Uditananda, Prim Wei, Zhang Yasunaga, Kazumichi Yu, Eunyoung Sarah Baker & McKenzie Ltd. SFDA Astellas Pharma Inc. PRA Korea Thailand China Japan Republic of Korea

Usavakidviree, Vinit Wijaya, Ellen Yeobin, Yun Yu, Yeo-Jin Food and Drug Administration, Glaxo Wellcome Indonesia C&C Research Labs. GlaxoSmithKline Ministry of Health Indonesia Republic of Korea Republic of Korea Thailand Wong, Farah Yi, Jungyoung Yuk, YeoJoo Uyama, Yoshiaki CSL Biotherapies Asia Pacific GE Healthcare sanofi-aventis Korea Pharmaceuticals & Medical Hong Kong Republic of Korea Republic of Korea Devices Agency Japan Wong, Kum Cheun Yim, Susanna Yun, Hye Jung Johnson & Johnson Pte Ltd Johnson & Johnson Ltd. JW Pharmaceuticals Uzu, Shinobu Singapore Hong Kong Republic of Korea Ministry of Health, Labor, and Welfare (MHLW) Wong, Wai Wai Yim, Youngwon Yun, Ji Hoon Japan Department of Health, HKSARG Korea Otsuka Pharmaceutical Berna Biotech Korea Corp. China Co., Ltd Republic of Korea Vermeulen, An Republic of Korea Janssen Research & Development Woo, Linda Yun, Ji-Suk Belgium Department of Health, HKSARG Yong, Kim Fresenius Kabi Korea Ltd. Hong Kong Iksu Pharmaceutical Co., Ltd Republic of Korea Walker, Michael Republic of Korea IFPMA Woo-hyuk, Chang Zhang, Fan Switzerland PharmAsia News/Elsevier Yoo, Hye Jong Johnson & Johnson Business Intelligence AstraZeneca Singapore Walker, Michael Republic of Korea Republic of Korea IFPMA Zhang, Honggang Switzerland Woo-Jong, Son Yoo, LEO Pharma China Creagene M-CES China Wang, Chao-Yi Republic of Korea Republic of Korea Taiwan Food and Drug Zhang, Hua Administration Woonhyuk, Choi Yoo, Kyung Jin Pfizer China Taiwan LSK Global PS Wyeth Korea China Republic of Korea Republic of Korea Wang, Chien-Chia As of April 15, 2011 GlaxoSmithKline Wu, Lei Yoo, So Young Taiwan UCB Korea OIAA Co., Ltd. China Republic of Korea Wang, Fanrong Hangzhou MSD Pharmaceutical Yagn, Hyun Joo Yoo, Yonghae Co., Ltd. Beijing Branch Handok Pharmaceuticals Co., Ltd. Allergan China Republic of Korea Republic of Korea

Wang, Jane Yahagi, Yuichi Yoon, ByungIn Shanghai Roche ASKLEP Inc. C&R Research, Inc. Pharmaceuticals Ltd. Japan Republic of Korea China Yang, Brian Yoon, Hyeyoung Wang, Jiahong PAREXEL International Novartis Korea Abbott Laboratories Taiwan Republic of Korea United States Yang, Hyunju Yoon, Jeongsook Wang, Na Daiichisankyo Ildong Pharmaceutical Co., Ltd Shanghai Roche Republic of Korea Republic of Korea Pharmaceuticals Ltd. China Yang, Jooha Yoon, Sangyee KRPIA Samil Pharm.Co.,Ltd. Wang, Rebecca Republic of Korea Republic of Korea Shanghai Roche Pharmaceuticals Ltd Yang, Jyunyan Yoon, Sogyem China Eli Lilly and Company BMS Korea Wang, Yingbo Taiwan Republic of Korea Daiichi Sankyo Pharmaceutical (Beijing) Co., Ltd. Yang, Tina Yoshida, Hiroshi China AstraZeneca Mitsubishi Tanabe Pharma Taiwan Corporation Ward, Mike Japan Health Canada Yang, You Kyung Canada KPMA Youn, Haecheol Republic of Korea Yonsei University Dental Hospital Waterson, Adrian Republic of Korea AstraZeneca United Kingdom FLOORPLAN 16

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

April 26-28, 2011 Parallel track Grand Hilton Hotel, Seoul, Republic of Korea Main Hotel 2 Fl. Main Hotel • 2nd Floor Plan

•S i z e of booth: 3M( W ) X 2M( L ) •C a pa bil i ty of G ra nd bal l room foy er: 20 booths in tota l •Nec es s i ti es for booth c ontra c tor : F l oor protec tor( fa bri c ) , E x tens i on c ord • P ower : l es s tha n 2K W per booth ( i f more tha n 2 K W /booth needs , pl ea s e di s c us s i n a dv anc e) S peaker ready room

C offee

VIP 5 3 1 ROOM 6 4 2

Plenary S ession EXHIBITOR LIST

Presented by 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 further SSG’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)

Core Services Value-added Services • Value creation through network consultancy • Cold chain handling and validated shipper boxes • Secondary labeling and repackaging of IP • Returns & Destruction services • Secured and confidential storage • IVRS and IWRS updating • Regulatory Assistance • Comparator and ancillary supplies sourcing • Kit-building of lab supplies • Biological specimens shipment • Transport management

Anti-Counterfeit Solution Real-time Intelligence SSG has developed an anti-counterfeiting solution - ZiP CHECK which combines both serialisation and SMS technologies. The key to securing your commercial and clinical supply chain is by applying serial number to products to allow end to end traceability and authentication.

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 Pharma Zuellig Pharma Korea Specialty Solutions Group Pte Ltd Tel: +65 6546 8188 Tel: +82 (02) 2006-0600 Fax: +65 6546 8288 Fax: +82 (02) 2006-0650 [email protected] http://www.zuelligpharma.com/ssg [email protected] Connect with us to connect with Asia Presenters Biographies ALPHABETIZED BY LAST NAME 18

Ms. Ruth Lee Choo Ai is the Director for the Enforcement Branch Ms. Agnes Chan was trained as a pharmacist and has worked at in Health Sciences Authority, the National Drug Regulator in the Health Sciences Authority (HSA) of Singapore since 2001. Singapore. She has a MBA degree from the Monash University She started as a clinical reviewer and her current career focuses (Australia) and a BSc (Pharmacy)(Honours)(1986) from the on medicines regulations and regulatory policies. As a regulatory National University of Singapore. consultant, Agnes played a key role in the legislative review of health products laws as well as the development of regulatory In 2004, she joined the Enforcement Branch at the Health frameworks in Singapore. She is also actively involved in regional Sciences as the Deputy Head(Investigation) and rose to the rank harmonization initiatives in particular the ASEAN Pharmaceutical of Director in Jan 2011. Products Working Group and in international collaborative programmes on regulatory development, including the WHO She has been a practicing pharmacist for close to 17 years in Paediatric Medicines Regulators’ Network. 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 Ms. Jennifer Chen joined the R&D-based Pharmaceutical of Singapore since 1986. Association Committee as Director of Legal Affairs in February 2006. Her responsibilities at RDPAC cover the intellectual In November 2006, she was nominated as one of the Vice- property-related issues for the pharmaceutical Industry, as well Chairs for the WHO International Medical Products Anti- as compliance initiatives in connection with the RDPAC Code of Counterfeiting Taskforce (IMPACT) Planning Group during Practice on the Promotion of Pharmaceutical Products. the Bonn() meeting and since then she has been actively involved in the organization and implementation of the Before joining RDPAC, Jennifer worked for more than 10 years as various regional and international initiatives and projects, in her a legal practitioner with both Chinese and international law firms, capacity as the Vice Chair. 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 Dr. Yuki Ando, MSc. is currently Principal Reviewer for worked as the acting legal director for Pfizer China from early Biostatistics, Office of New Drug II, Pharmaceuticals and Medical 2004 through the end of 2005, where she started to focus her Devices Agency (PMDA). She received a master’s degree in professional interest in the pharmaceutical Industry. engineering from Tokyo Science University in 1997, and joined the Pharmaceuticals and Medical Devices Evaluation Center, Jennifer Chen earned a PhD in Law and a Master in Law from which was subsequently transformed into the current PMDA. Her Renmin University Law School (Beijing, China), and an LLM experience as a statistical reviewer at the Japanese regulatory from the George Washington University Law School. She was body is almost 14 years. She is a leader of the Biostatistics admitted to the Chinese Bar in 1996 and the New York State Bar Group and she is involved in the trial design training course Association in 2002. for statisticians and non-statisticians in PMDA in addition to reviewing new drugs. Dr. Herng-Der Chern, PhD degree from National Taiwan University in 1983 and his Ph.D. degree in pharmacology from Dr. André Broekmans, PhD is currently Vice President Most of University of Pittsburgh in 1994. Before he joined Center for World Regulatory Policy & Regulatory Affairs with MSD and Drug Evaluation in 1998, Dr. Chern was the head of Division of located in Oss, the Netherlands. Clinical Pharmacology of National Taiwan University Hospital and associate professor in National Taiwan University. Until March He joined pharmaceutical industry in 2001 and held different 2011, Dr. Chern had been the Executive Director of Center for senior positions in regulatory affairs within Organon respectively Drug Evaluation and in charge of technical review of IND/NDA/ Schering Plough until the company was officially acquired by HTA for Taiwan’s government. Under his leadership, Center for MSD in November 2009. Drug Evaluation is one of a few regulatory agencies in Asia that can perform in-house review based on good regulatory science. André has practiced as a general internist at the Leiden University Hospital where he also did his PhD in thrombosis In the last 12 years, Dr. Chern plays a very active role in research. After a career with the Netherlands Heart Foundation promoting ICH concept, GCP education, good review as head of Medical Affairs he joined the Medicines Evaluation practice, bridging study, new drug development and Health Board in the Netherlands. The first years he was head of the Technology Assessment in Asia. Dr. Chern served as the APEC Clinical Assessment Department and later the Chief Executive representative for the ICH-GCG group in ICH 5 and ICH 6. of the Agency. He served at the Management Board of the European Medicines Agency, in his last year as chairman of Dr. Chern involved in many regional harmonization initiatives the Board. Early 2000 he was Professor of Pharmaceutical especially the APEC Network of Pharmaceutical Regulatory Technology Assessment at the Utrecht University, the Science leaded by Taiwan since 2000 and APEC Best Regulatory Netherlands. Practice Project since 2011. Not only serving as a speaker and session chair in many DIA conferences, Dr. Chern was also the André is member of the Scientific, Regulatory and Manufacturing guest editor for four issues, focused on the current status of Policy Committee (SRMPC) of EFPIA, the Regulatory Policy infrastructure and regulatory science of new drug development and Technical Standards Committee (RPTS) of IFPMA. On in Asia, for Drug Information Journal in 1998, 2003 and 2009. Dr. behalf of EFPIA he is member of the Steering Committee of the Chern is the winner of 2006 DIA Outstanding Service Award for International Conference on Harmonization (ICH) and the Global his contribution to DIA. Cooperation Group (GCG). Presenters Biographies ALPHABETIZED BY LAST NAME 19

Dr. Sannie Chong SF obtained her Bachelor (Honours) Degree Ms. Weon Do in Chemistry, majoring in Bio-organic Chemistry and Toxicology. Education: PhD research in drug design and drug delivery systems had also Seoul National University, Master of Pharmacology, Feb. 1986 taken her to universities in the UK and the US. Seoul National University, Bachelor of Pharmacy, Feb. 1984

She is currently the Director of the Generics & Biosimilars Branch Professional Experience: as she oversees the registration of generics and biosimilars in a • Sanofi Aventis Korea timely fashion in order to ensure efficient use of high-quality and • Head of Regulatory Affairs and Market Access safe medicine. On the regional and international front, Dr. Chong represents Singapore and HSA in the Technical Working Group Social Experience: of the ASEAN Consultative Committee for Standards & Quality • Chair of Regulatory Committee in KRPIA (ACCSQ) as Chair of Process Validation as well as Co-Chair of • Cochair of Regulatory Committee in KRIPA ASEAN Variation Guidelines. She also assists the World Health Organization (WHO) in product assessment as part of the WHO prequalification of medicines program. 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 Mr. Alistair Davidson President of Global Regulatory Affairs and Safety since January Senior Director, Regulatory Affairs, Asia-Pacific, PPD, Cambridge, 2007, and Vice President of Global Safety since December 2005. England (from April 2011). Prior to joining Amgen, Dr. Eisenberg was the Vice President Previous positions: of Lilly Global Product Safety. At Lilly he also led Clinical •Senior Director, Global Regulatory Affairs, Quintiles Development teams in Cardiovascular, Critical Care, Transnational, Bracknell, England (2010-2011). and Inflammation Therapeutic Areas as Vice President - •Vice-President, International Regulatory Affairs, Internal Medicine and in discovery as Executive Director of GlaxoSmithKline, Greenford, England (2006-2010). Cardiovascular Research and Clinical Investigation. •Director, Worldwide Vaccines Registration, GlaxoSmithKline Biologicals, Rixensart, Belgium (2003- 2006). Dr. Eisenberg received his M.D. from New York Medical College •Vice-President & Regulatory Director, GlaxoSmithKline and M.P.H. in Tropical Medicine from Tulane University School of Asia-Pacific, Singapore, (2000 - 2003). Public Health. He was a Professor of Medicine at Washington •Regional Regulatory Director, Asia, SmithKline Beecham, University in St. Louis where his academic career, over 18 years, Singapore (1997 -2000). was focused on basic and clinical research in cardiovascular •Regional Regulatory Manager, SmithKline Beecham disease and thrombosis. This work led to over 100 publications in International, Brentford, England, (1991 – 1997). peer-reviewed journals and books. He has been involved in the •Wellcome Environmental Health: Product Registration, discovery and development of numerous new molecular entities Berkhamsted, England, (1988 – 1991). in both his academic and industry career. •Norbrook Laboratories Ltd: Regulatory Affairs, Newry, N Ireland, (1985 – 1988). Dr. Eisenberg has led the development and registration of multiple NMEs in cardiovascular and critical care. In addition, he Experience: has extensive experience in global safety and risk management •Leading strategic regulatory role over many years for the high- programs for drug development programs and post-marketing in growth Emerging Markets and Asia-Pacific multiple therapeutic classes. •Significant international exposure and in-depth M&A experience. •Global regulatory experience at the headquarters of the world’s In his current role, Dr. Eisenberg has also led teams in filing leading vaccine company, during a period of major innovation multiple marketing authorization applications globally of novel and expansion. biopharmaceuticals in hematology, endocrine and inflammation •Leading regulatory teams across different cultures, functions therapeutic areas. He leads teams responsible for the global and roles. regulatory strategies in oncology, nephrology, inflammation, •Extensive direct experience and responsibilities for regulatory metabolic and cardiovascular disease therapeutic areas. In activities in Europe, Asia (including India and China), Middle addition to leading the global regulatory and safety organization East countries (including Turkey and Pakistan), Latin America at Amgen, he has represented Amgen and industry in global (including Brazil and Mexico) and Africa. and FDA regulatory meetings, scientific forums and molecule- •Previous Industry roles include experience as Chair of EFPIA’s specific forums related to drug development. (European Federation of Pharmaceutical Industries and Associations) International Regulatory Affairs Group, and as a member of IFPMA’s (International Federation of Pharmaceutical Dr. Fermin Ruiz de Erenchun, PhD, is a board certified Manufacturers and Associations) Regulatory Policy and dermatologist with more than 16 years of pharmaceutical Technical Standards Committee. industry. During his career, he has work in local, regional and •Organised and led the first two face-to-face conferences global medical affairs functions in the area of inflammation and involving Industry and Middle East regulatory agencies oncology. He has also developed a broad experience in clinical (1996 and 1997), now organised by DIA; chaired Organising development and life cycle management in global roles and Committee for IFPMA’s 2008 Asia Regulatory Conference. 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. Presenters Biographies ALPHABETIZED BY LAST NAME 20

Dr. Georges France for Licensing, Medical and Regulatory Affairs of the Jouveinal Title: Vice President Global Quality Strategy & IAQC Group, Deputy Managing Director and Director of Scientific and (International Affiliate Quality Compliance), PFIZER, Based In Technical Affairs of SNIP (French Manufacturers Association) and Maidenhead UK Department Head at the Broussais Hospital in .

Summary: Georges started working in a general hospital as a For seven years Dr Juillet was a Member of the official Registration biologist and following this held QP/Pharma responsibilities for Committee (AMM), Transparency and Post Marketing Committees 15 years in France in small, middle sized () and large of the French Health Ministry, where he represented Industry. He Pharma companies (Schering Plough and Wyeth in 96). In 2005 was also a member of the Board and the Executive Board of the he moved to the UK for Wyeth and lead the Quality organisation Pharmaceutical Industry Association in France. for the EMEA Region Europe, Middle East & Africa as VP. He took his new role when Pfizer acquired Wyeth. He was Chair of the EFPIA Scientific Technical and Regulatory Policy Committee for 10 years . He was a Member of the Regarding external responsibilities, for EFPIA, he is Topic ICH Steering Committee and Co-Chair of the ICH GCG. He is Leader for ICH Q-IWG (Quality Implementation Working Group), the Chairman of the IFPMA Regulatory Policy and Technical previously for Q10 and for IFPMA he is quality representative for Standards Committee RPTS (Regulatory Policy and Technical Standard) He is a Member of the French Académie Nationale de Pharmacie and corresp Member of the Académie de Médecine. Georges is a Doctor of Pharmacy, post graduate degree in Pharmacology, Production Management & INSEAD Business He is President Elect of the Drug Information Association (DIA) School. He is member of French Academy of Pharmacy.

Dr. Megan Keaney, Principal Medical Adviser, Therapeutics Dr. Yukio Hiyama, PhD, is Visiting Scientist at National Institute Goods Administration of Health Sciences. He received Ph.D. degree in Chemistry from the University of Tokyo in 1979. He leads MHLW’s study groups Dr Megan Keaney was appointed Principal Medical Adviser of to draft GMP related guidance and to propose the regulatory the Therapeutic Goods Administration (TGA) in February 2011. framework under the revised Pharmaceutical Affairs Law. He led She joined TGA from the Commonwealth Department of Health an industry-government Human Science project on evaluation and Ageing where, most recently, she was acting head of the methods for pharmaceutical development and manufacturing Diagnostic Services Branch in the Medical Benefits Division control. He is a member of Pharmaceutical and Food Council and responsible for policy development and implementation that co-chair of JP Chemical Monograph Committee. He has been ensured access for all Australians to high quality pathology and involved in the ICH discussion for Q8, Q9 and Q10. He is the topic diagnostic imaging services. leader for Q9 and Q10 for MHLW. His previous work experiences Before joining the department in late 2009, Dr Keaney held include positions in Pharmaceutical Development in Upjohn Co. senior positions at Avant Australia’s largest medical indemnity in US and in Japan, scientist at National Institutes of Health, USA organisation. Over her 18 year career in medical indemnity she and post-doctoral fellow at University Illinois. 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 Dr. In-Jin Jang, PhD, is Professor of Department of adverse events, claims and risk management topics Pharmacology, Seoul National University College of Medicine and Director of Department of Clinical Pharmacology, Seoul National Until December 2009 Dr Keaney was Chair of the Board of the University Hospital. National Breast & Ovarian Cancer Centre and a member of the Advisory Council of Cancer Australia, which are Australia’s two He obtained degrees of M.D. and PhD in 1987 and 1992 at Commonwealth government funded cancer control agencies. Seoul National University, College of Medicine. He is a clinical pharmacologist who majors in pharmacogenomics, population Dr Keaney graduated in 1981 and her clinical background is in PK/PD modeling, simulation of clinical trial and early clinical drug Accident and Emergency and she continues to work periodically development methodologies. He worked as a visiting research in the Emergency Department of Alice Springs Hospital. Alice fellow at Center for Drug Development Science, Georgetown Springs is situated in Central Australia and is the regional University Medical Center from 1998 to 2000, where he was medical centre for indigenous Australians who live in remote involve in population PK/PD modeling and simulation of clinical communities. trial. At Seoul National University and Hospital, he is responsible for research and education in the field of clinical pharmacology, Dr Keaney has taken over the position of Principal Medical especially pharmacogenomics and PK/PD. He is in charge of Adviser from Dr Ruth Lopert who has taken up the role of therapeutic drug monitoring consultation and execution of Visiting Professor in Health Policy at George Washington phase 1 clinical trials at Clinical Trials Center as a director of University, Washington DC. Department of Clinical Pharmacology and Therapeutics at Seoul National University Hospital. Dr. Susanne Keitel is a licensed pharmacist with a Ph.D. in pharmaceutical technology. Her work experience includes 10 Dr. Yves Juillet is a specialist in internal medicine, cardiology and years in pharmaceutical development in industry, with five years pharmacology, and is at present Senior Advisor to LEEM (the as Department Head of ”Pharmaceutical Development/Oral Association of Pharmaceutical Industries in France ). Dosage Forms“ at the former Schering AG, Berlin. From 1997 to 2005, she held the position of Division Head Pharmaceutical Prior to this appointment he was Director of Public Affairs of Quality at the Federal Institute for Drugs and Medical Devices Aventis , Director of Pharmaceutical and Public Affairs of Hoechst (BfArM), Germany. She additionally served as Acting Head of the Marion Roussel, Inspector General of Roussel Uclaf, Vice President Division European Procedures from November 2003. Presenters Biographies ALPHABETIZED BY LAST NAME 21

From July 2005 to October 2007, Susanne Keitel was Head of EU, Associate Director, Worldwide Regulatory Strategy – Emerging International Affairs at BfArM. During her time with BfArM, she Markets. In this position Arun looked after the regulatory strategy represented the agency in a number of EU committees, including from molecule to market for key emerging markets like India, and the Joint CHMP/CVMP Quality Working Party (QWP), the EMEA oncology products. Meanwhile, Arun pursued his second MSc Paediatric Working Party and the European Commission’s Notice degree in Pharmaceutical Medicine from Hibernia College, Dublin to Applicants Group. She was actively involved in the International in 2009 specializing in Pharmaceutical Regulatory Affairs in the Conference on Harmonization (ICH), where she acted as the EU Emerging Markets. topic leader and rapporteur for the ICH guidelines on stability testing and pharmaceutical development. On a national level, she Arun left Pfizer Global Research and Development in 2010 and was, from 2001 to 2007, Chair of the German Pharmacopoeia joined GloaxoSmithKline based at Head Office in London as and the German Homeopathic Pharmacopoeia. Since October Director, Global Regulatory Affairs (Asia-Pacific, Japan and 2007, Susanne Keitel is Director of the European Directorate for Emerging Markets). the Quality of Medicine & HealthCare (EDQM) of the Council of Europe in Strasbourg. Dr. Justina A. Molzon, M.S. Pharm., J.D. is a pharmacist and She also lectures in the postgraduate course “Master of Drug attorney, and a commissioned officer in the U.S Public Health Regulatory Affairs” at Bonn University, where she is responsible Service. She is currently the Associate Director for International for the module on the quality dossier. In 2009, Dr. Keitel was Programs, Center for Drug Evaluation and Research (CDER), elected as corresponding Foreign Member at the French U.S. Food and Drug Administration and a member of CDER’s Académie Nationale de Pharmacie. 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 Mr. John Kiser is Sr. Director, Global Submission Operations at Registration of Pharmaceuticals for Human Use (ICH). In this Abbott Laboratories with over 20 years experience in the Life capacity, she serves as CDER’s representative to the ICH Steering Science area and 14 years in regulatory operations focusing on Committee. She also coordinates CDER’s activities related to drug submissions to regulatory agencies. Active member of the President’s Emergency Plan for Aids Relief (PEPFAR) and is industry trade associations PhRMA (US) and EFPIA (EU) as well involved in technical outreach to the PEPFAR focus countries. as the Standards Development Organization HL7 in the support She received her B.S. (with honors and distinction) and M.S. of progressing standards for electronic exchange of information. in Pharmacy, with a concentration in pharmaceutics and Education includes a Bachelor of Science in Computer Science pharmacognosy, from the University of Rhode Island and law from Bowling Green State University and a Masters in Quality & degree from the Chicago-Kent College of Law/Illinois Institute of Regulatory Science from Northwestern University. 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 Mr. Thomas T. Kubic, President & CEO Reservation and also the Regional Pharmacist Consultant and Pharmaceutical Security Institute Inspector for the Health Care Financing Administration’s Survey and Certification Review Branch, in Chicago. Upon leaving the Tom Kubic is a former Deputy Assistant Director of the FBI with Public Health Service to go to law school, she was a clinical national and international investigative experience. pharmacist in the critical care area of Northwestern University’s teaching hospital. After law school, she maintained a private law Working closely with a new Pharmaceutical Security Institute’s practice and worked with a pro bono legal program for persons twenty-four members to insure the integrity of pharmaceuticals with AIDS. In 1990, she rejoined the Public Health Service to work and, most importantly, to protect public health, he was selected in FDA’s Office of Generic Drugs. In 2008 she was honored with as the President & CEO in October 2008. Under his leadership, the US Public Health Service Mary Louise Andersen Leadership PSI has been completely reorganized to emphasize information Award (pharmacist of the year) for extraordinary dedication and sharing and private-public sector cooperation. leadership in support of global public health. In 2009 she was awarded an exemplary service award by the Surgeon General of Mr. Kubic represents the Institute at numerous international the United States for her international efforts and in 2010 received meetings, conferences and seminars. He has provided testimony a Dean’s List Award from the University of Rhode Island College concerning the international nature of counterfeiting and its of Pharmacy. She is very grateful to have the opportunity to devastating impact before senior government officials around work with international drug regulatory authorities in assuring the the world. He currently serves as an officer with the Partnership safety, efficacy and quality of pharmaceuticals worldwide. 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. Ms. Deborah Monk holds a Bachelor of Pharmacy and a Diploma in Hospital Pharmacy from the University of Sydney.

Mr. Arun Mishra finished his undergraduate degree in Biology She started her working life as a clinical pharmacist in a major from a prestigious university in India. Subsequently Arun finished teaching hospital in Sydney. his first MSc in System Design and Mathematical Modelling from a Dutch university in 2001. Arun worked in the international Deborah joined the innovative medicines industry association regulatory arena for number of years including working for Pfizer in mid-1989. She is now the Director of Innovation and Industry Global Research and Development Centre in Sandwich UK. In Policy at Medicines Australia. 2006 he was deputed to Pfizer India as Head, Regulatory Affairs. Arun had been an active member of different trade associations Deborah’s responsibilities within Medicines Australia include involved in shaping the Indian and many key emerging market’s seeking to negotiate a more favourable Government industry pharmaceutical regulatory environment. In 2008 Arun came back policy environment that will attract greater global investment to to Pfizer Global Research and Development, Sandwich UK as Australia and managing the Ethical Conduct Program. Presenters Biographies ALPHABETIZED BY LAST NAME 22

Dr. Jacques Morénas is civil servant as « pharmacien général as a senior reviewer at the Pharmaceutical and Medical Devices de santé publique » and belongs to the pharmacist-inspector Evaluation Center, the former body of the Pharmaceutical and profession. He is graduated as a pharmacist from the faculty Medical Devices Agency of pharmacy (1977) [University of Clermont-Ferrand (France)]. (PMDA) (2000-2002). His team is currently receiving a grant He received his pharmacist inspector degree from the National for COE for pediatric clinical trial network in Japan. He is School for Public Health (1980) [Rennes (France)] currently a member of the following: the advisory board for the PMDA, the Pediatric Working Group for the council for off-label He had different positions in the French health administration in and unlicensed drugs by the Ministry of Health, Labour and the Ministry of Health and in the regional inspectorate of Paris. Welfare (LHLW) , the Committee on Drugs of Japan Pediatric Society, the Steering Committee (vice chairman) for the Japan He joined the French Drug Agency in 1993 and is actually Society of Developmental Pharmacology and Therapeutics, assistant director of the Inspection and Companies department an.d the IUPHAR. Executive Committee of the Pediatric Clinical in the French Health Products Safety Agency (AFSSAPS), in Pharmacology Section. 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), Ms. Jalene Poh is a regulatory consultant with the Pharmaceutics including training (for the inspectors of the French Agency). At & Biologics Branch of the Singapore Health Sciences Authority the European level, he is the AFSSAPS’s representative to the (HSA). She received her pharmacy degree at the National GMDP IWG of European Medicines Agency (EMEA-Londres) and University of Singapore and was practicing as a pharmacist Chair of its “Compliance Group”. At the International level, he prior to joining HSA. Throughout her 10 years in the Agency, is member of the Committee of Officials of the Pharmaceutical besides her primary role in clinical evaluation of drug application Inspection Cooperation Scheme (PIC/S) and its Executive submissions, she was also involved in project management for Bureau. He is also involved, as EU expert, in ICH discussions new drug submissions, regulatory processes and policies as well concerning implementation of Q8, Q9 and Q10 documents and as drafting of regulatory guidance documents. 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. Lembit Rägo was, before joining the World Health Organization (WHO), Professor of Clinical Pharmacology (Tartu University, Estonia) and the founder and first Director Dr. Patricia Mozzicato In the mid-1990s, Patricia Mozzicato, General of the Estonian Drug Regulatory Authority, State M.D. joined Bristol-Myers Squibb Pharmaceutical Research Agency of Medicines. In December 1999, Dr Rägo joined WHO Institute as a drug safety physician where she was responsible Headquarters in Geneva, as Coordinator of the Quality Assurance for safety monitoring of marketed oncology and antiretroviral and Safety: Medicines (QSM) team (nowadays in the Department products. While at B-MS, she became a physician advisor for of Essential Medicines and Pharmaceutical Policies). In 2001 implementation of MedDRA Version 2.1, including conversion he initiated, in addition to the units routine work, the WHO of legacy data. She trained most of the initial BM-S users of Prequalification Programme. He is a WHO observer to the ICH MedDRA and became the primary physician responsible for Steering Committee and to the ICH Global Cooperation Group mapping new verbatim terms to MedDRA and for making (GCG). He is also a Vice-Chairman of the Uppsala Monitoring recommendations for Change Requests to the MSSO. She also Centre Board. During 2002 to 2004 he was a member of the established and chaired the MedDRA committee of B-MS’s drug Council of International Organizations of Medical Sciences safety department. (CIOMS) Working Group on Pharmacogenetics (which resulted in a book “Pharmacogenetics. Towards improving treatment with In 2001, Dr. Mozzicato joined the MedDRA Maintenance and medicines”, CIOMS, 2005). He is also serving as designated Support Services Organization (MSSO) where she is currently Technical Officer for several professional NGOs in official Chief Medical Officer. She has several responsibilities at the relations with WHO (such as CIOMS and IUPHAR). He is a MSSO including terminology development and maintenance, common speaker in DIA Annual meetings and has a number of and medical support for various MSSO products and services. scientific and regulatory affairs related publications. 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. Ms. Dato’ Eisah A. Rahman, Senior Director of Pharmaceutical Services. Ministry of Health Malaysia graduated as a pharmacist After graduation from Tufts University School of Medicine, Dr. from the Curtin University of Technology, Western Australia Mozzicato trained in pathology/neuropathology at the University in 1977. She later obtained a postgraduate degree, M. Sc in of Vermont College of Medicine and at Queen’s University/ Pharmaceutical Analysis from the University of Manchester, United Kingston General Hospital in Ontario, Canada. She practiced Kingdom in 1986. She has served the Ministry of Health Malaysia as pathology for several years in Syracuse, New York. She is a pharmacist since 1979 to date and has held several key positions certified by the American Board of Pathology in anatomic and throughout her 30 over years of service with the ministry. clinical pathology and has obtained Special Qualification in neuropathology. 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 Dr. Hidefumi Nakamura, PhD is a Chief of the Divisioin for and Licensing Section, Deputy Director of Centre for Product Clinical Trials, Clinical Research Center, National Center for Child Registration and later in 2006 became Director of National Health and Development (NCCHD), Tokyo. He is a pediatrician Pharmaceutical Control Bureau. In 2007, she moved on to and a pediatric pharmacologist trained at the National Medical become Director of Pharmacy Enforcement and in 2008 was Center, Tokyo (1989-91), Hospital for Sick Children, Toronto, promoted to become Senior Director of Pharmaceutical Services, ON, Canada (1991-1996) and the Rainbow Babies and Childrens Ministry of Health where she takes charge of the entire pharmacy Hospital, Cleveland, OH USA (1996-1999). He also has experience programme in Malaysia. Presenters Biographies ALPHABETIZED BY LAST NAME 23

Throughout her career, she has contributed tremendously to the Dr. Yoshiaki Uyama is currently Director, Regulatory Science overall development of the pharmacy service and the domestic Research Division, Office of Regulatory Science, Pharmaceuticals pharmaceutical sector. Besides her involvements in various & Medical Devices Agency (PMDA). He leads the research of committees at national level, she has also participated in several regulatory science in PMDA and coordinates PMDA’s activities healthcare related meetings and conferences in the international relating to regulatory science. He is also the leader for PMDA arena particularly in the area pertaining to drug regulations. Omics Project (POP).

With her vast experience in the area of regulatory control He received his Ph.D. degree from the Nagoya City University and her involvement in ASEAN harmonisation initiatives for in 1994 and became a research fellow for Japan society for the pharmaceuticals, she is now the Chair of ASEAN Consultative promotion of science. He was a post-doctoral fellow in University Committee for Standards and Quality (ACCSQ) Pharmaceutical of Calgary, Canada in 1994-1995 before being a researcher in the Product Working Group. She has also been appointed as a WHO Tokyo Metropolitan Institute of Medical Science (1995-1998). Expert Advisory Panel on Drug Policies and Management. 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 Dr. Peter Richardson, is a pharmacist, with a Ph.D. in Devices Evaluation Center of National Institute of Health Science pharmaceutics from The Queens University, Belfast. He (PMDEC) in 2001 and continues his career on drug review in worked for a number of years in the pharmaceutical industry PMDA since April 2004, including the career as the Review in the UK and Italy in the area of formulation research and Director (2007-2010), ICH Technical Coordinator (2004-2009) development, with companies such as Bristol-Myers Squibb, and the topic leader of ICH E15 and E16. 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 Dr. An Vermeulen, PhD, is a Senior Director in the Clinical assessing chemical and abridged applications and wide ranging Pharmacology Division at Janssen Research & Development and is experience of biotechnology/biological applications. He was the Global Head of the Advanced Modeling & Simulation group. UK delegate for the Biologics Working Party of the CHMP prior to joining the European Medicines Agency. His role as Head An joined the Preclinical Pharmacokinetics group of the of Biologicals in Quality of Medicines sector requires scientific Janssen Research Foundation in 1992, moving on to the Clinical and regulatory input into many aspects of biotechnology and Pharmacokinetics department in 1999. As a pharmacokineticist biological medicinal products, CHMP, Biologics, Cell and Gene she has made significant contributions to the preclinical and Therapy Working party, Blood products Working party, Vaccines clinical development of many marketed products such as and Similar Biologicals Working Parties activities. SPORANOX, LIVOSTIN, REMINYL, RISPERDAL, RISPERDAL CONSTA, INVEGA and INVEGA SUSTENNA, and to numerous products in development at J&J. In December 2001, An joined Dr. Romi Singh has extensive scientific and management the J&J PRD Advanced PK/PD Modeling and Simulation group to experience in top-tier pharmaceuticul and biotechnology develop her modeling, simulation and managerial competencies. companies such as Burroughs/GlaxoWellcome, Merck and Amgen. He is well published in drug discovery, preclinical Since May 2006 An has global responsibility for the Advanced development and is internationally recognized as an expert PK/PD Modeling and Simulation group. Under her leadership, on regulatory affairs, clinical trials and drug registrationss in the group supports development decisions and filing activities developing countries. He is actively involved in advancing for NMEs and line extensions, using modeling and simulation regulatory policy for biologies and small molecules in emerging approaches as strategic tools in support of compound countries through various advocacy and outreach efforts. He selection, dose and dose-regimen selection, and clinical trial is a lecturer at various universities and holds an adjunct faculty design optimization. The group is also active in quantitative position at Thomas Jefferson University. Dr. Singh is currently an pharmacology and translational research at the preclinical- Executive Director of Global Regulatory & Safety at Arngen. He clinical interface, and in quantitative “landscape analysis” of obtained an undergraduate degree from St. Stephen’s College, efficacy and safety attributes of our development candidates doctorate from the University of Washington. relative to competitor products.

An holds a Pharmacy degree and Ph.D. in Pharmaceutical Dr. Jean Temeck is certified by the American Academy of Sciences from the University of Ghent, Belgium. During her Pediatrics in general pediatrics and in pediatric endocrinology. career, An has (co)authored more than 30 peer reviewed She graduated from the Georgetown University School of publications in scientific journals and book chapters. Medicine. She received her training in general pediatrics at Furthermore, An represents Janssen Research & Development the St. Louis Children’s Hospital and the Cardinal Glennon and co-leads the PK/PD Modeling Platform under the umbrella Memorial Hospital for Children in St. Louis. After completing a of the Dutch Top Institute Pharma, a public-private partnership fellowship in pediatric endocrinology at The New York Hospital of eleven academic and industry groups to develop mechanistic Cornell Medical Center, she joined their faculty as an Assistant PKPD modeling technologies in the fields of schizophrenia, Professor of Pediatrics and was appointed Director of the cardiovascular safety, and other domains in drug discovery and Pediatric Diabetes Clinic. Dr. Temeck joined the Food and development. 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. Presenters Biographies ALPHABETIZED BY LAST NAME 24

Ms. Chao-Yi (Joyce) Wang, Senior Specialist, Division of Drugs Mr. Adrian Waterson is a Pharmacist by training with 30 and New Biotechnology Products, Taiwan Food and Drug years’ experience spanning many of the key areas of the Administration, Department of Health, Taiwan. Pharmaceutical Industry, including R&D, Manufacturing and Commercial. Education: LL. M. (Master of Law), Department of Law, Soochow University, Adrian has worked in development roles in pre-formulation Taipei, Taiwan. M. S., Department of Preventive Medicine, College research and in formulation development. These have including of Medicine, Ohio State University, USA the design of solid, liquid and freeze dried formulations and instrumented tablet presses. Adrian then took these skills to Work Experience & Training: the manufacturing environment in technical and leadership roles • Section Chief, Division of Drugs and New Biotechnology including Management of a sterile products plant. Products, Taiwan Food and Drug Administration, Jan. 2010- Jan. 2011 Following a period in a commercially lead emerging markets • Section Chief, Bureau of Pharmaceutical Affairs, Department of business unit, Adrian has spent the last 10 years in Regulatory Health, Nov. 2006- Dec. 2009 Affairs leadership roles mainly focused on Latin America, Middle • Specialist, Bureau of International Cooperation, Department of East, Africa, Eastern Europe and Asia Pacific. Heath, Nov, 2004- Oct. 2006 • Visiting Scholar, Fulbright Foundation, USA, 2003 Adrian works for AstraZeneca and is currently Regulatory • Executive Education, John F. Kennedy School of Government, Director for Asia Pacific and Regulatory Portfolio Leader for Harvard University, USA, 2007 Oncology, Infection, Respiratory and Inflammation across all International Markets.

Dr. Rebecca Wang, FRCP, FACC, Head, Regional Center for Asia Pacific, Roche Product Development Safety Operation, Mr. Kum Cheun Wong, Director Global Regulatory Policy and Shanghai Roche Pharmaceutical Ltd. Rebecca serves a dual Intelligence, Asia Pacific, Janssen (a divison of Johnson & role as the Director of Safety Management at Shanghai Roche Johnson Pte Ltd) Pharmaceutical Companies of Johnson & Pharmaceuticals Ltd as well as the Head of the Regional Johnson Center for Asia Pacific for Roche Product Development Safety Operation. She leads a safety operation group in Beijing and a Kum Cheun (KC) is Director Global Regulatory Policy & safety evaluation group in Shanghai since joining Roche in 2007. Intelligence Asia Pacific in Janssen based in Singapore. KC leads in the development of regulatory policy guidance and Rebecca has worked in industry since 1999 . She had worked as intelligence for AP region. He is active in regional pharmaceutical a Clinical Research Physician in Heart Failure and Hypertension. harmonization activities in Asia Pacific including the ASEAN AstraZeneca LP US, Senior Medical Medicator of Cardiovascular PPWG harmonization and APEC LSIF. He is member and Products, Global Medical Affairs at Weyth US and Senior Medical technical expert of the ASEAN Pharmaceutical Research Industry Director of Clinical Drug Safety, AstraZeneca US. As the Global Association (APRIA) involved in the technical discussion with Drug Safety Physician for Crestor in AstraZeneca from 2003-7, the ASEAN regulators, member of ISPE and trade association she led the global Crestor safety surveillance team in performing regional regulatory networks. safety signal detection and anslysis, preparing periodic safety reports and regulatory submissions and imlementing a rigorous Prior joining J&J in 2007 as Associate Director, Global pharmacoviglance program on Crestor worldwide. Regulatory Policy & Intelligence Asia, KC was with Gillette Asia Pacific (P&G) where he developed regulatory strategy, systems Prior to her entry into the industry, Rebecca had held and processes to provide product registration and regulatory various academic and professional positions includng Chief compliance for consumer, cosmetics and medical devices for the of Cardiology , Philadelphia Geriatric Center and Chief of AP region. Cardiology in the University of Hong Kong. She was lsited as one of the top cardiologists for seniiors in the Philadelphia Magazine He was the former Drug Registration Branch’s Deputy Head in June 1998. responsible for leading a team of regulators in the Quality Evaluation and Submissions section of the Centre for Drug Rebecca received Her MD from the University of Hong Kong. Administration at the Singapore Health Sciences Authority. She is Board Certified in the areas of Geriatric Medicine, He was actively involved in the development of Singapore’s Cardiovasculatr Disease and Internal Medicine. She has registration regulations and policies, and contributed to the contributed more than 70 publications to various peer reviewed ASEAN Harmonization of Pharmaceutical Products technical journals. guidelines such as the ASEAN Process Validation Guideline and Stability Guideline for product registration.

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. NOTES 25 Presented by