November 9, 2011
Pharmaceuticals and Medical Devices Agency
It is our great pleasure to bring your attention to the 2011 APEC Multi-Regional Clinical Trials TOKYO Workshop, held in Tokyo, Japan, from November 1 to 2, 2011.
The TOKYO Workshop succeeds "2010 APEC Multi-Regional Clinical Trials SEOUL Workshop" and keeps its aim of promoting Multi-Regional Clinical Trials in the Asia-Pacific region. As this year's host nation, Japan sets TOKYO Workshop's theme as "Seeking to promote Multi-Regional Clinical Trials in the APEC economies". TOKYO Workshop is co-organized by the Ministry of Health, Labour and Welfare, the Pharmaceuticals and Medical Devices Agency, the Society for Regulatory Science of Medical Products, and the APEC Harmonization Center.
Prior to TOKYO Workshop, the 4th China-Korea-Japan Director-General Meeting will also be held in Tokyo, chaired by MHLW/PMDA. The Director-General Meeting will discuss the tripartite cooperation in clinical studies and other items.
TOKYO Workshop, taking the outcome of the China-Korea-Japan Director-General Meeting into account, aims to further advance what SEOUL Workshop achieved. The Workshop invites speakers from the regulatory authorities, industries and academia in the APEC economies, to have the following 4 sessions of presentations and discussion.
1) DG meeting report symposium
2) Importance of Asia in global development strategy
3) Study design of Multi-Regional Clinical Trials
4) Case studies (oncology)
At the closing of the Workshop, panel discussion will be held and concluding remarks will be given to summarize the outcome.
Tuesday, November 1 and Wednesday, November 2, 2011
(The workshop has already been held.)
Hitotsubashi Memorial Hall
National Center of Sciences Building 2-1-2, Hitotsubashi, Chiyoda-ku, Tokyo 101-0003 Japan
|Co-hosted by:||Ministry of Health, Labour and Welfare (MHLW)
Pharmaceuticals and Medical Devices Agency (PMDA)
Society for Regulatory Science of Medical Products (SRSM)
APEC Harmonization Center (AHC)
|Supported by:||Japan Pharmaceutical Manufacturers Association (JPMA)|