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14th DIA Japan Annual Meeting 2017

[DIAmond Session 2] To Deliver Innovative Drugs to the Patients Appropriately and Quickly – Recent Topics and Visions for Future of Regulatory Authorities among US, EU and Japan

    Session Chair(s)
      Yasuhiro  Fujiwara, MD, PhD

      Yasuhiro Fujiwara, MD, PhD

      • Director General, Strategic Planning Bureau
      • National Cancer Center, Japan
    Lots of efforts have been made by academia, industry and regulatory agencies, in order to deliver innovative drugs to patents quickly. In this session, representative from FDA, EMA and MHLW will introduce their own activities as well as examples and they will discuss future direction under the recent high-uncertainly environment. The discussion includes their accelerated approval process (ie. FDA: Breakthrough designation, EU: PRIME and Japan: Sakigake) would how to be applied to accelerate appropriate medicine to patients. Also, how efficacy and safety of new therapy to rare disease, where usually typical double-blind trial is difficult to be conducted, is to be evaluated with sufficient validity from scientific and ethical point of views, in order to be delivered to the patients. Efforts by regulatory authorities to incorporate emerging novel science and regulatory science into the processes to establish new medicine, as well as the various collaboration among academia, industry and regulatory agencies globally, will be discussed by the presenters as panel discussion format.
      Francesco  Pignatti, MD

      Early Access Mechanisms: EMA Experience with Oncology Drugs

      Francesco Pignatti, MD

      • Head of Oncology, Haematology, Diagnostics
      • European Medicines Agency (EMA), United Kingdom
      Kazuhiko  Mori, MSc

      To Deliver Innovative Drugs to the Patients Appropriately and Quickly

      Kazuhiko Mori, MSc

      • Councilor for Pharmaceutical Affairs, Minister’s Secretariat
      • Ministry of Health, Labour and Welfare (MHLW), Japan
      Rajeshwari  Sridhara, PhD

      US Food and Drug Administration Expedited Programs for Serious Conditions

      Rajeshwari Sridhara, PhD

      • Director, Division of Biometric V, Office of Biostatistics, OTS, CDER
      • FDA, United States

Contact us

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

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