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[V7-S4] Future of the Pharmacovigilance from Development to Commercial – Where is the Spirit of ICH E2E Guideline in Japan?
Session Chair(s)
Tatsuo Kagimura, MPH
Chief, Department of Analysis
Translational Research Informatics Center (TRI), Japan
It has been a long time since the guidelines for consistent safety action from development to commercial. However, typical and routine postmarketing observational studies have been conducted in Japan based on the reexamination system. This has not been changed after the publication of ICH E2E guideline in 2005 and introduction of J-RMP in 2013. On the other hand, the science of pharmacovigilance has dramatically changed and the gap between US/EU and Japan is increasing. In this session, ideal pharmacovigilance in Japan will be discussed among important stakeholders.
Speaker(s)
Pharmacovigilance in RMP and Pharmacovigilance in Post Approval Re-Examination System
Mamoru Narukawa, PhD, RPh
Kitasato University School of Pharmacy , Japan
Professor, Department of Clinical Medicine (Pharmaceutical Medicine)
Why? What is the root cause of current PharmacoVigilance systems in Japan?
Kotonari Aoki, MS
Chugai Pharmaceutical Co., Ltd., Japan
Head of Real World Data Science Dept. Drug Safety Div.
The transition of Pharmacovigilance in JAPAN
Akiko Ogata
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Division Director
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