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[V3-S4] Global Direction of Safety Assessment with Pharmaco-Epidemiology
Session Chair(s)
Yoshiaki Uyama, PhD, RPh
Associate Executive Director
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
For the safety assessment of medical products, a pharmaco- epidemiological approach utilizing electronic medical records has been progressing, but the situation for usage of electronic medical records differs considerably by country. In this session, regulators from US, EU and Japan will share the current status and challenges regarding active utilization of e-medical records to have convincing evidences for postmarketing safety measures that each regulatory authority requires. At the panel discussion, we will focus on how to build a foundation for international cooperation and discuss challenges.
Speaker(s)
PMDA’s Activities Promoting Pharmaco-Epidemiological Safety Assessment (MIHARI & MID-NET Initiatives)
Yoshinori Takeuchi, DVM, PhD, MPH
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Office of Medical Informatics and Epidemiology
US FDA's Activities in Pharmacoepidemiological Safety Assessment
Gerald Dal Pan, MD, MHS
FDA, United States
Director, Office of Surveillance and Epidemiology, CDER
EMA’s Activities Promoting Pharmaco-Epidemiological Safety Assessment Including EnCepp Initiative (Tentative) <Remote Presentation via Internet>
Peter Richard Arlett, MD, FFPM, FRCP
European Medicines Agency, Netherlands
Head Data Analytics and Methods Task Force
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