Menu Back toV7-S1

14th DIA Japan Annual Meeting 2017


[V7-S1] Draft Regulatory Guidance for Patient Registry and the Current Situation

    Session Chair(s)
      Akihiro  Hirakawa, PhD

      Akihiro Hirakawa, PhD

      • Project Associate Professor, Department of Biostatistics and Bioinformatics
      • Graduate School of Medicine, The University of Tokyo, Japan
    Under the Clinical Innovation Network (CIN) scheme, which aims for promoting medicine development by effective utilization of medical information generated by patient registries, an intensive development of patient registry has been preceded by an industry wide consortium of National Medical Research Centers (NCs) and Pharmaceutical companies, which was proposed by Ministry of Health, Labuor and Welfare. Under this circumstance, academic societies and PMDA have been dedicating to discuss data quality standard regarding the registry data which to be used for Japan NDA. There are various perspectives about data quality and way of registry operation. Is this session, we will discuss regulations surrounding the patient registry and issues for the ideal effective utilization of registry data.
    Speaker(s)
      Taro  Shibata, MSc

      Discussion on “Draft: Basic Principles on the Reliability of Patients Registry Data When Utilized in the Application for Marketing Authorization and Post-Marketing Surveillance of Medical Products”

      Taro Shibata, MSc

      • Director, Biostatistics Division
      • Center for Research Administration and Support, National Cancer Center, Japan
      Harumasa  Nakamura, MD

      Current Status and Issues of Remudy in an Effort to Promote Clinical Innovation Network

      Harumasa Nakamura, MD

      • Section Chief of the Department of Clinical Research Support
      • National Center of Neurology and Psychiatry, Translational Medical Center, Japan
      Kazuhito  Shiosakai

      Expectation for the Disease Registry Data from a Pharmaceutical Company

      Kazuhito Shiosakai

      • Manager, Statistical Analysis Group, Biostatistics & Data Management Department
      • Daiichi Sankyo Co., Ltd., Japan
      Shimon  Tashiro, PhD

      Shimon Tashiro, PhD

      • Head, Office for Bioethics, Center for Public Health Science
      • 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