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14th DIA Japan Annual Meeting 2017


[V1-S5] Regulations for Conditional Accelerated Approval System and Early Access to Drug Products

    Session Chair(s)
      Toshio  Fujimoto, MD, MBA

      Toshio Fujimoto, MD, MBA

      • Vice President, Medicines Development Unit Japan
      • Eli Lilly Japan K.K., Japan
    Recently, various regulations have been developed to make realize early access to drug products. In addition to the conventional Orphan Designation, Priority Review and Advanced Medical Care, plans for SAKIGAKE Designation, Conditional Accelerated Approval System, Expanded Access Trial and Patient-requested Treatment System have been established. This session will clarify the outline of Conditional Accelerated Approval System and compartmentalization with other regulations, discuss in depth for Expanded Access Trial and Patient-requested Treatment System including actions to be taken by pharmaceutical industry and in medical practice.
    Speaker(s)
      Yasuhiro  Araki

      Conditional Early Approval System and Other Comparable Approval System in Japan

      Yasuhiro Araki

      • Deputy Director, Pharmaceutical Evaluation and Licensing Division
      • Ministry of Health, Labour and Welfare (MHLW), Japan
      Kae  Nakashima, DVM, PhD, MS

      Conditional Early Approval System and Expanded Access Trials - Expectations and Challenges from Industry Perspective -

      Kae Nakashima, DVM, PhD, MS

      • Pfizer Japan Inc., Japan
      Taro  Shibata, MSc

      Can We, Academic Researchers, Contribute for an Expediting Access Scheme in Japan?

      Taro Shibata, MSc

      • Director, Biostatistics Division
      • Center for Research Administration and Support, National Cancer Center, Japan
      Yasuhiro  Fujiwara, MD, PhD

      Yasuhiro Fujiwara, MD, PhD

      • Director General, Strategic Planning Bureau
      • National Cancer Center, Japan

Contact us

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

Tel: +81-3-6214-0574
Fax: +81-3-3278-1313
Japan@DIAglobal.org
www.diajapan.org