Presentation Files

Mon. April 14

Chair: Mr. Shuuichi Kishida, Senior Executive Director, PMDA (Japan)

13:30-13:40 Opening Remarks

Dr. Tatsuya Kondo, Chief Executive, PMDA (Japan)

13:40-14:00 Report for the Director-General level Meeting on the tripartite project on Clinical research

Dr. Toshiyoshi Tominaga, International Planning Director (Pharmaceutical Affairs), Minister's Secretariat, MHLW (Japan)

14:00-14:30 Global Development: China's perspective and the Role of SFDA

Mr. Zhang Wei, Director General Department of Drug Registration, SFDA (China)

14:30-15:00 Global Development: Korea's perspective and the Role of KFDA

Dr. Young-Chan, Kim, Director General, Pharmaceuticals Headquarters, KFDA (Korea)

15:00-15:30 Global Development: Japan's perspective and the Role of MHLW

Dr. Tatsuo Kurokawa, Councilor, Minister's Secretariat, MHLW (Japan)

15:30-16:00 Coffee Break

Mon. April 14: Session 1

Session 1 Current Status and Future Direction of GMP

Purpose: As pharmaceutical production and distribution became global, this session will focus on current status regarding standards, inspection practices and industry performance relative to GMP in the three countries for future collaboration in the region.

Chair: Dr. Yukio Hiyama, Section Manager, Division of Drugs,
National Institute of Health Sciences (Japan)

16:00-16:30 Latest Trend of Drug Quality / GMP in Korea

Dr. In-Kyu, Kim, Director, Chemistry & Cardiovascular Team,
KFDA (Korea)

16:30-17:00 Latest Trend of Drug Quality / GMP in Japan

Mr. Shingou Sakurai, Director for GMP Inspection, Office of Compliance and Standards, PMDA (Japan)

17:00-17:30 Latest Trend of Drug Quality / GMP in China

Ms. Li Jinju, Consultant Department of Drug Safety Inspection, SFDA (China)

17:30-18:00 Panel Discussion

Panelists: Dr. In-Kyu, Kim, Ms. Zhang Yanli, Mr. Shingou Sakurai

Mon. April 14: Session 2

Session 2 Post-Marketing Safety Measures

Purpose: The post marketing safety measures are becoming more and more importance with the progress of simultaneous world-wide development and the emergence of innovative biopharmaceuticals. This session will discuss the current status of and the possible cooperation in the post-marketing safety measures in the three countries with a view to ensuring appropriate use of new drugs.

Chair: Mr. Kaoru Misawa, Director, Office of Safety, PMDA (Japan)

16:00-16:30 Post-Marketing Safety Measures in China

Ms. Li Jinju, Consultant Department of Drug Safety Inspection, SFDA (China)

16:30-17:00 Post-Marketing Safety Measures in Korea

Dr. Joon-Su, Shin, Deputy Director, Pharmaceutical Management Team, KFDA (Korea)

17:00-17:30 Post-Marketing Safety Measures in Japan

Mr. Akira Kawahara, Chief Safety Officer, PMDA (Japan)

17:30-18:00 Panel Discussion

Panelists: Ms. Li Jinju, Dr. Joon-Su, Shin, Mr. Akira Kawahara

Mon. April 14: Reception

18:15-20:15 Reception

Tue. April 15 AM

Global Clinical Trial and Development / Industry's View

Purpose: As part of simultaneous and worldwide drug development strategies, China, Korea and Japan have all begun to take part in Global Clinical Trials in these days.
The purposes of this session are to introduce the perspectives of pharmaceutical industries and regulators and to discuss the possibility of mutual cooperation toward the progress of drug development in the East Asian region.

Chair: Mr. Kazuhiko Mori, Associate Center Director, PMDA (Japan)

9:30-10:00 Global Clinical Trial and Development: JPMA's Perspective

Mr. Hidetoshi Shuto, Corporate Officer / Vice President, Clinical Development I, Development Astellas Pharma Inc. (Japan)

10:00-10:30 Global Clinical Trial and Development: PhRMA's Perspective

Dr. Timothy R. Franson, Vice President for Global Regulatory Affairs Operational Committee Member, Eli Lilly (USA)

10:30-11:00 Global Clinical Trial and Development: EFPIA's Perspective

Dr. Tsutae Den Nagata, Director General, EFPIA Japan
Statutory Auditor, Medical Advisor, GlaxoSmithKline K.K. (Japan)

11:00-11:30 Coffee Break

Global Clinical Trial and Development / Regulator's View I

Chair: Mr. Kazuhiko Mori, Associate Center Director, PMDA (Japan)

11:30-12:00 Review Policies for Global Drug Development: Singapore's Perspective

Dr. Christina LIM, Administrator, Health Products Regulation Group, Senior Advisor, International Collaboration, HSA (Singapore)

12:00-12:30 Review Policies for Global Drug Development: Thailand's Perspective

Dr. Yuppadee Javroongrit, Assistant Director & Head of International Affairs & IND Section, Food and Drug Administration,
Thai FDA (Thailand)

12:30-13:40 Lunch

Tue. April 15 PM

Global Clinical Trial and Development / Regulator's View II

Chair: Dr. Toshiyoshi Tominaga, International Planning Director
(Pharmaceutical Affairs), Minister's Secretariat, MHLW (Japan)

13:40-14:10 Review Policies for Global Drug Development: Korea's Perspective

Mr. In-Beom, Kim, Deputy Director, Pharmaceutical Safety Policy Team, KFDA (Korea)

14:10-14:40 Review Policies for Global Drug Development: China's Perspective

Mr. Feng Yi, Chief of Office, Center for Drug evaluation, SFDA (China)

14:40-15:10 Review Policies for Global Drug Development: Japan's Perspective

Mr. Kazuhiko Mori, Associate Center Director, PMDA (Japan)

15:10-15:30 Japan's Study Group on Ethnic Factors in Clinical Data: Purpose and Current State

Dr. Masahiro Tokin, Section Manager, Division of Medical Safety Science, National Institute of Health Sciences (Japan)

15:30-16:00 Coffee Break

16:00-17:30 Panel Discussion

Panelists: Mr. In-Beom, Kim, Mr. Feng Yi, Mr. Kazuhiko Mori, Dr. Christina LIM, Dr. Yuppadee Javroongrit

17:30-17:40 Short Break

17:40-18:00 Summary Report

Dr. Satoshi Toyoshima, Executive Director, PMDA (Japan)

18:00-18:10 Closing Remarks

Mr. Toshiro Nakagaki, Director, Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, MHLW (Japan)

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Pharmaceuticals and Medical Devices Agency
Ministry of Health, Labour and Welfare

Secretariat of EAPRS 2008 PH (c/o Japan Convention Services, Inc.)
Tel:+81-3-3508-1243 Fax:+81-3-3508-1703 E-mail:eaprs08ph@convention.co.jp