|Event Date/Time: Oct 15, 2008||End Date/Time: Oct 16, 2008|
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 â€œAsk the Regulatorsâ€ will be held.