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14th DIA Japan Annual Meeting 2017

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

    Session Chair(s)
      Junko  Sato, PhD

      Junko Sato, PhD

      • Office Director, Office of International Cooperation
      • 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.
      Hiroshi  Watanabe, MD, PhD


      Hiroshi Watanabe, MD, PhD

      • Head of Center for Clinical Sciences
      • National Center for Global Health and Medicine, Japan
      Jianzhong  Zhao

      Current Status and Future Expectation of Clinical Studies by Academia

      Jianzhong Zhao

      • Senior Reviewer
      • Center for Drug Evaluation, China Food and Drug Administration, China
      Yasuto  Otsubo

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

      Yasuto Otsubo

      • Reviewer, Office of New Drug II
      • Pharmaceuticals and Medical Devices Agency (PMDA), Japan

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