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14th DIA Japan Annual Meeting 2017

[V1-S6] Optimal Use Guidelines (Future Direction of the System, Discussion of the NDA Review Process, and Status of Actual Medical Practice)

    Session Chair(s)
      Yuji  Kashitani

      Yuji Kashitani

      • Director, Regulatory Development, Regulatory Affairs Department
      • Takeda Pharmaceutical Company Limited, Japan
    Discussion on the direction toward the official introduction of ‘Optimal Use Guidelines’ being in trial operation from FY2016. This session will discuss including the future issues, the target products planned for the Guidelines, impact on creating NDA dossiers or review for NDA approval when introduced the Guidelines, or any change or impact to the actual medical practice when Guidelines are introduced.
      Eri  Sugiyama, MS

      About a Background and a Summary of Optimal Clinical Use Guidelines

      Eri Sugiyama, MS

      • Pharmaceutical Evaluation Division, Pharmaceutical Safety and Environmental Heal
      • Ministry of Health, Labour and Welfare (MHLW), Japan
      Hiroyuki  Muta

      Optimal Use Guidelines : from the Viewpoints of Pharmaceutical Industry

      Hiroyuki Muta

      • Senior Director, Regulatory Management
      • Ono Pharmaceutical Co., Ltd., Japan
      Makoto  Tahara, MD, PhD

      Optimal Use Guidelines: Impact on Medical Practice

      Makoto Tahara, MD, PhD

      • Head and Neck Medical Oncology
      • National Cancer Center Hospital East, Japan
      Yasuhiro  Fujiwara, MD, PhD

      Yasuhiro Fujiwara, MD, PhD

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

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

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