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[V2-S6] RMP in the Era of Medical Big Data
Session Chair(s)
Rei Maeda
Consultant, Independent Consultant for Drug PV, Japan
Medical Information Database research will soon be included in additional pharmacovigilance activities as one of the post-marketing surveillance. Going back to the concept of ICH E2E “Pharmacovigilance Planning,” we will discuss what pharmacovigilance activities should be like in RMP in general.
Speaker(s)
Guidance of ICH E2E "Pharmacovigilance Planning"
Tsugumichi Sato, PhD
Junior Associate Professor, Department of Pharmacy, Faculty of Pharmaceutical Sc, Tokyo University of Science, Japan
Epidemiological Review for Pharmacovigilance Planning in New Drug Applications
Chieko Ishiguro, PhD, MPH
Section Chief of Clinical Epidemiology, Department of Data Science, National Center for Global Health and Medicine, Japan
Is Your RMP Optimal?
Kotonari Aoki, MS
Head of Real World Data Science Dept. Drug Safety Div., Chugai Pharmaceutical Co., Ltd., Japan
Wataru Asakura, PhD
Office Director, Office of New Drug IV, Pharmaceuticals and Medical Devices Agency (PMDA), Japan