EMA Information Day on Measuring the Impact of Pharmacovigilance Activities

How to measure pharmacovigilance activities to be effective and efficient? At this EMA Info Day you will learn about the revised PRAC strategy for measuring the effectiveness of the EU pharmacovigilance activities.

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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