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14th DIA Japan Annual Meeting 2017

[V6-S2] Paradigm Shift in Global Development Strategy - How to Utilize ICH E17 GL in New Drug Development? -

    Session Chair(s)
      Manabu  Yanagisawa, PhD

      Manabu Yanagisawa, PhD

      • Associate Director, Japan Development Regulatory Affairs
      • Eisai Co., Ltd., Japan
    The ICH E17 guideline is expected to reach Step 4 in 4Q 2017. This session will provide an opportunity to discuss how to utilize E17 appropriately, where global development strategy move toward, and what can be done to induce a change in our strategy. We have experienced so many evaluations of consistent or similar results among ethnic groups under E5 guideline and we know how difficult evaluation of ethnic differences and consistency among ethnic groups are. Given those experiences, this session will also address the points to consider in planning a global development program by means of E17, newly introduced pooling strategies (pooled region, pooled subpopulation), what kind of information is need for pooling, when such information to be obtained, how to present results from the Multi-Regional Clinical Trials. Those discussions would contribute to your readiness for the paradigm shift in global development strategy.
      Nobushige  Matsuoka, PhD

      How should be the Future of Simultaneous Global Drug Development? - Road to Implementation of ICH E17 -

      Nobushige Matsuoka, PhD

      • Clinical Statistics
      • Pfizer Japan Inc., Japan
      Masahiro  Tohkin, PhD

      Ethnic Differences on Efficacy and Safety in a Multi-Regional Clinical Trial

      Masahiro Tohkin, PhD

      • Professor
      • Nagoya City University, Japan
      Koichi  Miyazaki, PhD

      The Impact of ICH-E17 on Clinical Development Strategy and Operations

      Koichi Miyazaki, PhD

      • Senior Director, Clinical Development Group, Asia Development Dept., R&D Div.
      • Daiichi Sankyo Co., Ltd., Japan
      Osamu  Komiyama

      Osamu Komiyama

      • Senior Manager, Regulatory Policy, Regulatory Affairs
      • Pfizer Japan Inc., Japan
      Yoshiaki  Uyama, PhD

      Yoshiaki Uyama, PhD

      • Director, Office of Medical Informatics and Epidemiology
      • Pharmaceuticals and Medical Devices Agency (PMDA), Japan
      Hiroshi  Takeda, MS

      Hiroshi Takeda, MS

      • Technical Officer
      • Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Contact us

Please contact the DIA Japan office in Tokyo for further information.

Tel: +81-3-6214-0574
Fax: +81-3-3278-1313