Apri 12,2011
Pharmaceuticals and Medical Devices Agency
Pharmaceuticals and Medical Devices Agency (PMDA) co-hosted "the Second China-Japan Symposium on Drug Development focusing on IND, Pre-Consultation, GMP and DMF System" in Beijing on March 29th 2011
Time / Date
9:00 - 17:40,March 29th(Tuesday),2011 (The symposium has already been held)
Venue
Hotel New Otani Chang Fu Gong
26 Jianguomenwai Avenue, Beijing, 100022, China
Agenda
Please click (
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| Chair: Mr. Xue Bin, (Deputy Director General ,CCPIE) | |
|---|---|
| 9:00 - 9:10 | Introduction & Opening Remarks |
| 9:10 - 9:50 | Key-note speech - SFDA /PMDA perspective on drug regulation Mr. Zhang Wei, Director General, Department of Drug Registration, SFDA  |
| Chair: Mr. Seiji Miyazawa (Director of International Affairs,JPMA) | |
| 9:50 - 10:50 | Theme: 1. IND system and Pre-Consultation system Objectives: To discuss and find ways how China and Japan improve each country's system Clinical Trial Notifications and Scientific Consultation System in Japan Mr. Yusuke Moriyama, Director of Review Management Division, Office of Review Management, PMDA IND Review Process and Consulting System in China Ms, Chen Xiaoyuan, Center for Drug Evaluation, SFDA |
| 11:00 - 11:40 | Theme: 1. IND system and Pre-Consultation system Clinical Trial Application and Consultation Systems in East Asia with Expected Improvements in China and Japan from an Industry Point of View Mr, Tetsuomi Takano, Asia Subcommittee, International Affairs Committee, JPMA (Head of Asian Project Management, Asian Development, Astellas Pharma Inc.) China Clinical Trial Application and Consultation System- an Industry Aspect- Dr. Wen Chang, RDPAC (Vice President, North Asian Regulatory Strategy & China Regulatory Sciences, BMS) |
| 11:40 - 12:00 | Q & A Session: |
| 12:00 - 13:00 | Lunch Break |
| Chair: Mr. Seiji Miyazawa (Director of International Affairs,JPMA) | |
| 13:00 - 14:40 | Theme: 2. GMP Objectives: To know new Chinese GMP system and seek the way of Mutual cooperation The Implementation Status and Schedule of China Drug GMP Supervision Mr. Wang Zhexiong, Chief Inspector, Department of Drug Safety & Inspection, SFDA GMP system in Japan and Globalization Efforts Dr. Shingou Sakurai, Office Director, Office of GMP/QMS Inspection, PMDA Activities of GMP Sub-Committee in JPMA Quality & Technology Committee Mr.Tsutomu Watanabe, GMP Subcommittee, Quality & Technology Committee, JPMA (Director, Regional Quality Operations Japan, Industrial Affairs, Sanofi-Aventis K.K.) Quality Risk Management for Quality System Dr. Xie Xin, RDPAC (Quality Director, Pfizer China) |
| 14:40 - 15:00 | Coffee Break |
| Chair: Dr. Kyoichi Tadano, Division Director of Planning and Coordination, Office of International Programs, PMDA | |
| 15:00 - 16:40 | Theme: 3. Drug master file (DMF) System Objectives: To understand Japanese DMF system and seek the way of Mutual cooperation Guidance on Drug Master File System in Japan Dr. Takashi Yoshitani, Master File Management Group, Administration Division I, Office of Review Administration, PMDA Research on the Administrative Rules of APIs, Pharmaceutical Excipients and Auxiliary Materials Master File Ms.Hou Renping, Director, Division of Pharmaceuticals, Department of Drug Registration, SFDA Pharmaceutical Company and (Drug) Master File in Japan Mr. Yoichi Takashita, Asia Subcommittee, International Affairs Committee, JPMA (Senju Pharmaceutical Co., Ltd.) To Establish a DMF System in China ? A Proposal by RDPAC Dr. Charles Tong, RDPAC (Director of Global CMC, Pfizer Global Research and Development, Pfizer China) |
| Chair: Dr. Toshiyoshi Tominaga (Office Director of International Programs, PMDA) | |
| 16:40 - 17:30 | Panel discussion: Focus on GMP/DMF System and Mutual cooperation |
| 17:30 - 17:40 | Closing Remarks Mr. Koichi Nishikawa (JPMA) |