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SESSION 1: THE REGULATORY FRAMEWORK FOR IMPACT EVALUATION OF PHARMACOVIGILANCE ACTIVITIES
Session Chair(s)
Marieke De Bruin, PharmD, PhD
Scientific Director
Utrecht Collaborating Centre for Pharmaceutical Policy and Regulation, Netherlands
Kaisa Immonen
Director of Policy
European Patients' Forum, Belgium
This session will provide an overview of the updated framework for the evaluation of the impact of regulatory decisions in pharmacovigilance based on workshop recommendations and practical experience.
Speaker(s)
Revised PRAC Strategy for measuring impact of regulatory decisions
June Raine, MD, MSc, FRCP
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Chief Executive
Impact evaluation of pharmacovigilance activities – industry perspective
Vicki Edwards, RPh
Abbvie, United Kingdom
Vice President, Pharmacovigilance Excellence and International QPPV
A conceptual framework for the evaluation of effectiveness of risk minimisation: Experience at the Danish Medicines Agency
Mona Vestergaard Laursen, MPharm
Danish Medicines Agency, Denmark
Senior Advisor, Data Analytics Centre
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