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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
Tokyo University of Science, Japan
Junior Associate Professor, Department of Pharmacy, Faculty of Pharmaceutical Sc
Epidemiological Review for Pharmacovigilance Planning in New Drug Applications
Chieko Ishiguro, PhD, MPH
National Center for Global Health and Medicine, Japan
Section Chief of Clinical Epidemiology, Department of Data Science
Is Your RMP Optimal?
Kotonari Aoki, MS
Chugai Pharmaceutical Co., Ltd., Japan
Head of Real World Data Science Dept. Drug Safety Div.
Wataru Asakura, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Office Director, Office of New Drug IV