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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
Associate Executive Director, Regulatory Science Center, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
FDA's Sentinel Program
Michael D. Nguyen, MD
FDA Sentinel Program Lead, OSE, CDER, FDA, United States
EMA Perspective
Agnès Saint-Raymond, DrMed
Head of Division International Affairs, European Medicines Agency, Netherlands
Improving the Use of Real World Evidence in the Regulatory Environment: Where Are We Heading in Canada?
Rhonda Kropp, BSN, MPH
Director General, Marketed Health Products Division, Health Canada , Canada