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)  |
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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 |
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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)  |
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12:00 - 13:30 |
Lunch |
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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 |
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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)  |
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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 |
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Chair: Dr. Toshiyoshi Tominaga, Office Director of International Programs, PMDA |
16:20 - 17:30 |
Panel Discussion |
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Panelists:
- Dr. Li Jinju (Department of Drug Registration, SFDA)
- Mr. Shinobu Uzu (International Planning Director, MHLW)
- Dr. Yang Zhimin (Center for Drug Evaluation, SFDA)
- Dr. Yoshiaki Uyama (Review Director, Office of New Drug III, PMDA)
- Mr. Shii Man (Chairman of the Board/General Manager, OBRI)
- Mr. Tetsuomi Takano (Director, Head of Asian Project Management, Asian Development, Astellas Pharma Inc., JPMA)
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17:30 - 17:40 |
Closing Remarks |
|
Mr. Koichi Nishikawa (JPMA) |