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14th DIA Japan Annual Meeting 2017

[V2-S6] RMP in the Era of Medical Big Data

    Session Chair(s)
      Rei  Maeda

      Rei Maeda

      • Sr. Regulatory Scientist, Surveillance&Epidemiology, Global Patient Safety Japan
      • Eli Lilly Japan K.K., Japan
    Medical Information Database research will soon be included in additional pharmacovigilance activities as one of the post-marketing surveillance. Going back to the concept of ICH E2E “Pharmacovigilance Planning,” we will discuss what pharmacovigilance activities should be like in RMP in general.
      Tsugumichi  Sato, PhD

      Guidance of ICH E2E "Pharmacovigilance Planning"

      Tsugumichi Sato, PhD

      • Junior Associate Professor, Department of Pharmacy, Faculty of Pharmaceutical Sc
      • Tokyo University of Science, Japan
      Chieko  Ishiguro, MPH

      Epidemiological Review for Pharmacovigilance Planning in New Drug Applications

      Chieko Ishiguro, MPH

      • Office of Medical Informatics and Epidemiology
      • Pharmaceuticals and Medical Devices Agency (PMDA), Japan
      Kotonari  Aoki, MS

      Is Your RMP Optimal?

      Kotonari Aoki, MS

      • Director, Safety Real World Data and Science, Drug Safety Data Management Dept.
      • Chugai Pharmaceutical Co., Ltd., Japan
      Wataru  Asakura, PhD

      Wataru Asakura, PhD

      • Office Director, Office of New Drug IV
      • 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