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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)
Mamoru Narukawa, PhD, RPh
Professor, Kitasato University, Japan
Pharmacovigilance in RMP and Pharmacovigilance in Post Approval Re-Examination System
Kotonari Aoki, MS
Head of Real World Data Science Dept. Drug Safety Div., Chugai Pharmaceutical Co., Ltd., Japan
Why? What is the root cause of current PharmacoVigilance systems in Japan?
Akiko Ogata
Division Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
The transition of Pharmacovigilance in JAPAN
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