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Regulators’ Utilization of Real-World Data in Pharmacovigilance Activities
Session Chair(s)
Michael Blum, MD, MPH
Deputy Director, Office of Pharmacovigilance and Epidemiology, CDER
FDA, United States
Regulatory agencies have conducted real-world studies of postmarketing safety concerns to inform their regulatory decision-making and explored safety surveillance methods using real-world data. This session will discuss the approach of the FDA, EMA, Health Canada, and PMDA, the challenges faced in exploring new methods and designing and conducting these studies, and future areas of research, including opportunities for international collaborative research.
Learning Objective : Explain the progress of utilizing real-world data in regulatory activities; especially in pharmacovigilance activities; Share examples of use of pharmacoepidemiological methodology to evaluate risk of medical products.
Speaker(s)
Regulator’s Utilization of Real-World Data in Pharmacovigilance Activities
Yoshiaki Uyama, PHD, MS, RPH
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Associate Executive Director
FDA's Sentinel Program
Michael D. Nguyen, MD
FDA, United States
FDA Sentinel Program Lead, OSE, CDER
EMA Perspective
Agnès Saint-Raymond, DrMed
European Medicines Agency, Netherlands
Head of Division International Affairs
Improving the Use of Real World Evidence in the Regulatory Environment: Where Are We Heading in Canada?
Rhonda Kropp, BSN, MPH
Health Canada , Canada
Director General, Marketed Health Products Division