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[V3-S4] What is the New GPSP Ordinance Requirements for Post-Marketing Studies Using Healthcare Database?
Session Chair(s)
Mitsune Yamaguchi, PhD
Director, Office of Non Clinical and Clinical Compliance I
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
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)
Basic Principles on Warranty of Reliability of Data when Preparing Re-examination Application Dossier by Using Electric Medical Record Database
Satoru Nakamura
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Inspection Director, Office of Non-clinical and Clinical Compliance
How to Utilize Data from MID-NET® for Re-Examination Application
Sayoko Harada, MPharm, RPh
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Office of Medical Informatics and Epidemiology
Readiness for GPSP among Database Vendors
Jin Uesawa, MBA
JMDC Inc., Japan
President
Pilot Study Using the Healthcare Database Looking ahead to GPSP Inspection
Shimpei Niwa, PhD
Daiichi Sankyo Company, Limited, Japan
Safety and Risk Management Department