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14th DIA Japan Annual Meeting 2017

[V4-S6] How Should a Collaboration between Academia & Industry be Promoted for an Efficient Medicine/Medical Device Development

    Session Chair(s)
      Hiroi  Kasai

      Hiroi Kasai

      • Head of Study Management Department, iACT
      • Kyoto University Hospital, Japan
    A strategic collaboration such as an investigator initiated clinical trial (IICT) for registration between academia and industry is the key to success to develop medicine/medical device more efficiently. Actually, there are successful cases of the strategic collaboration led to regulatory approval with IICT collaboration. There is the one advanced example of the three-way collaboration for a combination product consisting of medicine and medical device. In this session, an ideal collaboration model will be discussed from various points of view, academia, industry, and PMDA plays as the Japan NDA review.
      Manabu  Muto, MD, PhD

      Point of Consider to Collaborate with Industry on Investigator Initiated Clinical Trial for Registration - Academia’s Standpoint -

      Manabu Muto, MD, PhD

      • Professor, Department of Therapeutic Oncology, Graduate School of Medicine
      • Graduate School of Medicine, Kyoto University, Japan
      Izumi  Okugaito

      A Better Academia-Industry Collaboration Aiming for Regulatory Approval - The Experience of Cooperation with Investigator Initiated Clinical Trials -

      Izumi Okugaito

      • Department Manager, Prescription Products Development Department
      • Zenyaku Kogyo Co., Ltd., Japan
      Ken  Hatogai, MD, PhD

      Effective Coordination Between Academia and Industry from the Reviewer Side

      Ken Hatogai, MD, PhD

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

      Fumiaki Kobayashi, PhD

      • President
      • CTD inc., Japan

Contact us

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

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