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Measuring the Impact of Regulatory Pharmacovigilance in Europe and the United States
Session Chair(s)
Peter Richard Arlett, MD, FFPM, FRCP
Head Data Analytics and Methods Task Force
European Medicines Agency, Netherlands
Measuring the impact of pharmacovigilance allows us to improve performance and to demonstrate effectiveness. Frameworks for impact measurement will be discussed using EU/US situations as case studies. Views on optimal approaches will be explored.
Learning Objective : Distinguish between pharmacovigilance impact measures - process, behavior change and outcomes; Explore measuring outcomes in public health/administration in Europe/US; Illustrate measuring impact using the pharmacovigilance legislation; Identify expectations for measuring the impact of strengthened regulatory pharmacovigilance.
Speaker(s)
EU Perspective on Pharmacovigilance Impact
Peter Richard Arlett, MD, FFPM, FRCP
European Medicines Agency, Netherlands
Head Data Analytics and Methods Task Force
FDA Perspective on Pharmacovigilance Impact
Gerald Dal Pan, MD, MHS
FDA, United States
Director, Office of Surveillance and Epidemiology, CDER
Pharmacovigilance Impact Case Studies
Krista F. Huybrechts, PhD, MS, FISPE
Harvard Medical School, United States
Associate Professor of Medicine and Epidemiology
Panelist
Álmath Spooner, PhD
AbbVie, Ireland
Director of Regulatory Policy and Intelligence