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European Medicines Agency

Nov 14, 2017 8:00 AM - Nov 14, 2017 4:45 PM

30 Churchill Place, Canary Wharf, London, E14 5EU, United Kingdom

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.

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

Session Chair(s)

Vicki  Edwards, RPH

Vicki Edwards, RPH

Vice President, Pharmacovigilance Excellence and International QPPV, Abbvie, United Kingdom

June  Raine, MD, MSC, FRCP

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)

Emma  Du Four, MBA

Framework for utilising data to support decision making - Industry experience

Independent Regulatory and R&D Policy Professional, Independent, United Kingdom

Alison  Cave

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

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

Kaisa  Immonen

Patients' involvement in generating impact relevant data

Director of Policy , European Patients' Forum, Belgium

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