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 
Dr. Toshiyoshi Tominaga, Office Director, Office of International Programs, PMDA  |
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) |