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[V8-S5] Drug Development Activation in Pan-Asia Region
Session Chair(s)
Junko Sato, PHD
Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
In drug development, East Asia region, such as Japan, China, Taiwan and Korea, tends to be focused as “Asia” region, however, an environment to conduct multinational clinical trials in ASEAN region has been significantly improved. Indeed, ICH-GCP-complied multinational clinical study results with ASEAN countries have become on public. With this context, in this session, actual practice and situations of clinical study conduct in ASEAN region are to be introduced, and then potential activities in order to further enhance the momentum will be discussed. In order to achieve an ultimate goal, ie. early access to innovative new drug in Asian region, collaboration between East Asia and South East Asia as well as the joint contribution, ie. All Asia, to the drug development will be extensively discussed.
Speaker(s)
Hiroshi Watanabe, MD, PHD
Vice President, Hamamatsu University School of Medicine, Japan
TBC
Jianzhong Zhao
Senior Reviewer, Center for Drug Evaluation, China Food and Drug Administration, China
Current Status and Future Expectation of Clinical Studies by Academia
Yasuto Otsubo
Review Director, Office of New Drug II , Pharmaceuticals and Medical Devices Agency (PMDA), Japan
PMDA's Experiences with New Drug Applications including Data from Multi Regional (Asian) Clinical Trials