The 5th Multitrack Workshop in Japan

Venue: Town Hall Funabori

Location: Tokyo, Japan

Event Date/Time: Oct 15, 2008 End Date/Time: Oct 16, 2008
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To effectively develop new pharmaceutical products, clinical studies conducted in Europe, North America and Asia have become more global. At the same time the development of leading-edge therapies such as regenerative medicine and preventive drugs is advancing. With this focus in mind this workshop will identify and discuss the latest developments and practical issues in domestic and international pharmaceutical development. The workshop aims to be a venue for active exchange of opinions between people involved in pharmaceutical development worldwide.
The keynote address will be delivered by Dr. Tatsuo Kurokawa, Councilor of the Ministry of Health Labour and Welfare, and Dr. Hiroo Imura, Advisor to the President, Japan Science and Technology Agency, and Chairman, Foundation for Biomedical Research and Innovation.
The first day will focus on new issues related to regulations, with talks by regulators (FDA, PMDA) and businesses and a panel discussion session on Adaptive Design. In addition, there will be a session on safety as well as a session on regulatory updates from various Asian countries regarding global development based in each country.
On the second day, there will be discussion of global development issues and medical writing, eCTD, and clinical trial quality control. In the afternoon, a session called “Ask the Regulators” will be held.


4-1-1 Funabori, Edogawa-ku