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DIA 2018 Global Annual Meeting

PMDA Town Hall

    Session Chair(s)
      Toshiyoshi  Tominaga, PhD

      Toshiyoshi Tominaga, PhD

      • Associate Executive Director (for International Programs)
      • Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    During this forum, PMDA will share its activities to promote high-quality, innovative medical research and clinical trials meeting or exceeding international standards as well as its advocacy for the application of “Big Data” in medical practice. PMDA will present the latest details of regulatory aspects regarding its three primary services (review, safety, and the adverse event relief system (the “PMDA Safety Triangle”)) in addition to updates on its advanced product review system, regulatory capacity building activities, and international collaborations.
    Learning Objective : Discuss the latest information on Japanese regulatory initiatives and regulations; Identify how to update SAKIGAKE designation, MID-NET projects, etc. which were introduced in the PMDA Town Hall session in DIA the previous year.
      Nobumasa  Nakashima, PhD

      MHLW and PMDA’s General Policies on Regulating Innovative Products

      Nobumasa Nakashima, PhD

      • Director, Office of International Regulatory Affairs
      • Ministry of Health, Labour and Welfare (MHLW), Japan
      Tatsuya  Kondo, MD, PhD

      PMDA’s Innovation and Review System in Japan

      Tatsuya Kondo, MD, PhD

      • Chief Executive
      • Pharmaceuticals and Medical Devices Agency (PMDA), Japan
      Shinobu  Uzu, MSc

      New Pharmacovigilance Approach: Use of Real-World Data

      Shinobu Uzu, MSc

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