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 2: GETTING IT RIGHT: SYSTEMATIC COLLECTION OF IMPACT RELEVANT DATA THROUGHOUT THE PRODUCT LIFE-CYCLE

Session Chair(s)

Vicki Edwards, RPh

Vice President, Pharmacovigilance Excellence and International QPPV

Abbvie, United Kingdom

June Raine, MD, MSc, FRCP

Chief Executive

Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

This session looks at the generation of impact relevant data as a systematic process considering the need for, the nature of and the approach to data collection throughout a product’s life-cycle.

Speaker(s)

Framework for utilising data to support decision making - Industry experience

Emma Du Four, MBA

-, United Kingdom

Regulatory and R&D Policy Professional

How could novel technologies and access to real world data facilitate impact research?

Alison Cave, PhD

Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Chief Safety Officer

Patients' involvement in generating impact relevant data

Kaisa Immonen

European Patients' Forum, Belgium

Director of Policy

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