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Impact of Regulatory Measures to Optimise Benefit/Risk Decisions
Session Chair(s)
June Raine, MD, MSc, FRCP
Chief Executive
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
This session will outline approaches for measuring the impact of medicines regulation and of individual regulatory measures. The session will outline how impact measurement is critical to drive process improvement and improve regulatory systems for the benefit of patients. In four short presentations practical examples will be presented and the session will then have a discussion on how to collaborate for better impact measurement.
Learning Objective : 1) This review would provide an overview of the studies that assessed the impact of Risk Minimization Measures (RMMs) in Europe and try to showcase their strengths and limitations. 2) To our knowledge, there exists, no such review, on the studies evaluating the RMMs after the implementation of the new pharmacovigilance legislation 2012 in Europe.
Speaker(s)
Why Measure the Impact of Regulatory Action (and How)?
Peter Richard Arlett, MD, FFPM, FRCP
European Medicines Agency, Netherlands
Head Data Analytics and Methods Task Force
Measuring Regulation to Drive Process Improvement
Marieke De Bruin, PharmD, PhD
Utrecht Collaborating Centre for Pharmaceutical Policy and Regulation, Netherlands
Scientific Director
Assessment of the Studies Evaluating the Effectiveness of Risk Minimisation Measures in ENCePP e-Register
Vineet Jaiprakash Singh, MD, MSc
CSL Behring, Germany
Medical Evaluator, Global Clinical Safety & Pharmacovigilance
Martin Huber, MPH, MPharm
Federal Institute for Drugs and Medical Devices (BfArM), Germany
Pharmacovigilance Risk Assessment Committee (PRAC) Vice Chair
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