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[V3-S4] Global Direction of Safety Assessment with Pharmaco-Epidemiology
Session Chair(s)
Yoshiaki Uyama, PhD, MS, RPh
Associate Executive Director, Regulatory Science Center, 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)
Yoshinori Takeuchi, DVM, PhD, MPH
Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
PMDA’s Activities Promoting Pharmaco-Epidemiological Safety Assessment (MIHARI & MID-NET Initiatives)
Gerald Dal Pan, MD, MHS
Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
US FDA's Activities in Pharmacoepidemiological Safety Assessment
Peter Richard Arlett, MD, FFPM, FRCP
Head Data Analytics and Methods Task Force, European Medicines Agency, Netherlands
EMA’s Activities Promoting Pharmaco-Epidemiological Safety Assessment Including EnCepp Initiative (Tentative) <Remote Presentation via Internet>
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