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Tokyo Big Sight

2017 年 11 月 12 日 9:30 上午 - 2017 年 11 月 14 日 5:30 下午

3-11-1 Ariake, Koto-ku, Tokyo, 135-0063 Japan

14th DIA Japan Annual Meeting 2017

[V8-S5] Drug Development Activation in Pan-Asia Region

Session Chair(s)

Junko  Sato, PhD

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

TBC

Hiroshi Watanabe, MD, PhD

Hamamatsu University School of Medicine, Japan

Vice President

Jianzhong  Zhao

Current Status and Future Expectation of Clinical Studies by Academia

Jianzhong Zhao

Center for Drug Evaluation, China Food and Drug Administration, China

Senior Reviewer

Yasuto  Otsubo

PMDA's Experiences with New Drug Applications including Data from Multi Regional (Asian) Clinical Trials

Yasuto Otsubo

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Review Director, Office of New Drug II

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