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3rd China - Japan Symposium on Drug Development

March 30, 2012

Pharmaceuticals and Medical Devices Agency (PMDA) co-hosted "the 3rd China-Japan Symposium on Drug Development focusing on Current Status of Global Clinical Trials, Utilization of Clinical Data and Clinical Trial Consultation System" in Beijing on March 22nd 2012.

Time / Date

9:00 - 18:00, March 22, 2012 (The symposium has already been held)


Venue: Beijing Marriott Hotel City Wall
7 Jian Guo Men South Avenue, Dongcheng District • Beijing, Beijing 100005 China


Please click () to read the presentation file.

9:00 - 9:10 Introduction & Opening Remarks (CCPIE)

Chaired by CCPIE

9:10 - 10:00 Key- note speech
-Mr. Zhang Wei, Director General, Department of Drug Registration, SFDA
The Latest Developments of Drug Registration Administration in China
-Mr. Takeyuki Sato, Associate Center Director, PMDA
Current Topics of Pharmaceutical Regulatory Affairs in Japan

Chaired by JPMA/CCPIE

10:00 - 12:35 Theme: 1. Current Status of Global Clinical Trials in China and Japan, and Utilization of Clinical Trial Data - case studies
Objectives: To report on the Current Status of Global Clinical Trials and on Case studies in the Data Utilization in applications and reviews in China and Japan, and exchange the views on further advancement of Global Clinical Trials
10:00 - 10:30 -Dr. Takahiro Nonaka, Reviewer, Office of New Drug V, PMDA
Review experiences of global clinical trials in Japan
10:30 - 11:00 -Mr. Wang Tao, Director, Office of Chemicals Pharmaceuticals Clinical Evaluation II, CDE of SFDA
SFDA 's Perspective of Medical Review for Drug Registration
11:00 - 11:20 Coffee break
11:20 - 11:50 -Dr. Masaaki Kuwahara, Vice-chairperson of Regulatory Affairs Committee, JPMA
Senior Director, Regulatory Affairs Dept, Pharmaceutical Development Div.
Takeda Pharmaceutical Company Ltd.
Overview on Multi-Regional Clinical Trials in Japan from Sponsor's Point of View- Advantages & Issues in MRCT involving China-
11:50 - 12:20 -Dr. Shii Man, General Manager, Otsuka Beijing Research Institute Ltd..
Cases and Opinions on Clinical Trials by Japanese Pharmaceutical Companies in China
12:20 - 12:35 Q&A
12:35 - 13:40 Lunch break

Chaired by PMDA/SFDA

13:40 - 16:45 Theme: 2. Clinical Trial Management and Clinical Trial Consultation Systems
Objective: To introduce China's and Japan's clinical trial management systems, crystallize the points to consider upon conducting Clinical Trial Consultation Systems, then, go on to discussions to design Clinical Trial Consultation Systems that would contribute to promotion of Global Clinical Trials
13:40 - 14:10 -Ms. Emiko Kondo, Director, Office of Conformity Audit, PMDA
The PMDA's GCP Inspection Methods, the Current State of Overseas GCP on-site inspections by PMDA
14:10 - 14:40 -Dr. Li Jinju, Director, Drug Research Supervision Division, Department of Drug Registration, SFDA
Drug Clinical Trials Quality Management and Subject Protection
14:40 - 15:10 -Ms. Hana Sugai, Reviewer, Office of New Drug I, PMDA
Overview of Consultation System in Japan
15:10 - 15:30 Coffee break
15:30 - 16:00 - Dr.Yasushi Hasebe, Vice-chairperson of Subcommittee on application, Regulatory Affairs Committee, JPMA
Director, Regulatory Affairs Group, New Drug Affairs Department, R&D Division, Daiichi Sankyo Co.,Ltd.
Clinical trial consultation system (utility and successful cases from company's point of view)
16:00 - 16:30 Mr. Li Weiping, Senior RA Director of Xian Janssen Chair of RA WG, RDPAC
Industry Perspective On Clinical Trial Environment In China
16:30 - 16:45 Q&A

Chaired by PMDA

16:50 - 17:50 Panel Discussion:
From a point of view that intends to promote Global Clinical Trials in China and Japan, the panels exchange their views on the differences in the regulations and the issues arose in conducting Clinical Trials in China and Japan. Then panels will go on discussing the forms of China-Japan mutual cooperation.
Panelist: All speakers of Theme 1 & 2
17:50 - 18:00 Closing Remarks(JPMA)

JCN 3010005007409

Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki,
Chiyoda-ku, Tokyo 100-0013 Japan

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