Menu Back toV3-S4

14th DIA Japan Annual Meeting 2017


[V3-S4] What is the New GPSP Ordinance Requirements for Post-Marketing Studies Using Healthcare Database?

    Session Chair(s)
      Mitsune  Yamaguchi, PhD

      Mitsune Yamaguchi, PhD

      • Director for MID-NET project, Office of Medical Informatics and Epidemiology
      • Pharmaceuticals and Medical Devices Agency (PMDA), Japan
      Kunio  Itoh

      Kunio Itoh

      • Director & PMS Manager, Clinical Research & Pharmacoepidemiology Dept.
      • Taiho Pharmaceutical Co., Ltd., Japan
    The new GPSP, which is planned to be effect in April 2018, will accept the database utilization as the post-marketing surveillance for re-examination submission package. First, in this session, PMDA (Office of Non-clinical and Clinical Compliance) is going to explain the basic principles on assurance of data reliability for post-marketing studies based on electronic health information data. Second, the data holders including MID-NET® will introduce their activities for complying with the GPSP. Third, from industry’s point of view, efforts for establishing internal system will be present. At the end, in the panel discussion, current issues and future perspectives will be discussed.
    Speaker(s)
      Satoru  Nakamura

      Basic Principles on Warranty of Reliability of Data when Preparing Re-examination Application Dossier by Using Electric Medical Record Database

      Satoru Nakamura

      • Inspection Director, Office of Non-clinical and Clinical Compliance
      • Pharmaceuticals and Medical Devices Agency (PMDA), Japan
      Sayoko  Harada, MPharm, RPh

      How to Utilize Data from MID-NET® for Re-Examination Application

      Sayoko Harada, MPharm, RPh

      • Office of Medical Informatics and Epidemiology
      • Pharmaceuticals and Medical Devices Agency (PMDA), Japan
      Jin  Uesawa, MBA

      Readiness for GPSP among Database Vendors

      Jin Uesawa, MBA

      • President
      • Japan Medical Data Center Co., Ltd., Japan
      Shimpei  Niwa, PhD

      Pilot Study Using the Healthcare Database Looking ahead to GPSP Inspection

      Shimpei Niwa, PhD

      • Safety and Risk Management Department
      • Daiichi Sankyo Co., Ltd., 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