June 25,2010
Pharmaceuticals and Medical Devices Agency
Pharmaceuticals and Medical Devices Agency (PMDA) co-hosted the "2010 China-Japan Symposium on Global Clinical Trials and Ethnic Factors."
Date / Time
Friday, May 28, 2010 / 9:00 - 17:40
(The symposium has already been held)
Venue
JW Marriott Hotel Beijing
83 Jian Gguo Road, China Central Place, Chaoyang District, Beijing 100025, China
Agenda
Please click 
to read the presentation file
| Chair: Mr. Xue Bin, (Deputy Director General ,CCPIE) | |
|---|---|
| 9:00 - 9:05 | Opening Remarks Dr. Tatsuya Kondo (Chief Executive, PMDA)  |
| 9:05 - 9:45 | Keynote Speech |
| 9:05 - 9:25 | Dr. Tatsuya Kondo (Chief Executive, PMDA) |
| 9:25 - 9:45 | Mr. Zhang Wei (Director General, Department of Drug Registration, SFDA) |
| Chair: Mr. Xue Bin, (Deputy Director General ,CCPIE) | |
| 9:45 - 10:45 | Session 1: Government efforts to promote Global Clinical Trials and current situation of Pharmaceutical regulations |
| 9:45 - 10:15 | The Current Status of GCP Implementation in China Dr. Li Jinju (Department of Drug Registration, SFDA) |
| 10:15 - 10:45 | Japan's Regulatory Initiative to promote Global Clinical Development Mr. Shinobu Uzu (International Planning Director, MHLW) |
| 10:45 - 11:00 | Coffee Break |
| Chair: Mr. Seiji Miyazawa, Director of International Affairs, JPMA | |
| 11:00 - 12:00 | Session 2: Current and future trends in clinical research on Ethnic Factors |
| 11:00 - 11:30 | Global Clinical Trials in China Dr. Cui Yimin (Peking University) |
| 11:30 - 12:00 | Ethnic differences in PK and PD of anti-rheumatic drugs Prof. Shinichi Kawai (Internal Medicine (Omori), School of Medicine, Faculty of Medicine, Toho University) |
| 12:00 - 13:30 | Lunch |
| Chair: Dr. Kyoichi Tadano, Division Director of Planning and Coordination, Office of International Programs, PMDA | |
| 13:30 - 16:00 | Session 3: Challenges on Clinical trials and approval reviews in consideration of Ethnic Factors |
| Reviewer's Viewpoints | |
| 13:30 - 14:00 | Registration and Review system in China Dr. Yang Zhimin (Center for Drug Evaluation, SFDA) |
| 14:00 - 14:30 | Global Drug Development in Consideration of Ethnic Factors Dr. Yoshiaki Uyama (Review Director, Office of New Drug III, PMDA) |
| Industry's Viewpoints | |
| 14:30 - 15:00 | China's current state of global clinical trials conducted by Japanese pharmaceutical manufacturers Mr. Shii Man (JPMA-Beijing) |
| 15:00 - 15:30 | New Strategy on Multinational Clinical Trials in China and Japan in Consideration of Ethnic Factors Mr. Tetsuomi Takano (Director, Head of Asian Project Management, Asian Development, Astellas Pharma Inc., JPMA) |
| 15:30 - 16:00 | A Bridging Strategy Driven by Patient Need and Contemporary Science Mr. John Powell (Scientific Advisor of Roche Product Development Center in Asia Pacific , RDPAC) |
| 16:00 - 16:20 | Coffee Break |
| Chair: Dr. Toshiyoshi Tominaga, Office Director of International Programs, PMDA | |
| 16:20 - 17:30 | Panel Discussion |
Panelists:
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|
| 17:30 - 17:40 | Closing Remarks |
| Mr. Koichi Nishikawa (JPMA) | |