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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)
June Raine, MD, MSC, FRCP
Chief Executive, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Revised PRAC Strategy for measuring impact of regulatory decisions
Vicki Edwards, RPH
Vice President, Pharmacovigilance Excellence and International QPPV, Abbvie, United Kingdom
Impact evaluation of pharmacovigilance activities – industry perspective
Mona Vestergaard Laursen, MPHARM
Senior Advisor, Data Analytics Centre, Danish Medicines Agency, Denmark
A conceptual framework for the evaluation of effectiveness of risk minimisation: Experience at the Danish Medicines Agency
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