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 3: METHODOLOGIES FOR IMPACT EVALUATION

Session Chair(s)

Bruce Guthrie

NHS Research Scotland Primary Care Research Champion, University of Dundee, United Kingdom

Mona Vestergaard Laursen, MPHARM

Senior Advisor, Data Analytics Centre, Danish Medicines Agency, Denmark

This session focuses on the validated methods for evaluating the impact of regulatory actions in terms of public health outcomes and what can we learn from case examples.

Speaker(s)

Christine Hallgreen, DRSC, PHD

Associate Professor, University of Copenhagen, Denmark

Methodological approaches to assessing risk minimisation interventions – study design, target population, data source, and outcome measures

Daniel Morales, MD, PHD, MRCP

Epidemiologist, European Medicines Agency, Netherlands

Time series regression as analytical approach – case examples

Nawab Qizilbash, MD, PHD, MRCP, MSC

Head, OXON Epidemiology, Spain

Outcome measures to evaluate the effectiveness of risk minimisation in EU PAS studies: A quantitative review

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