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European Medicines Agency Scientific Guidance on Postauthorization Efficacy Studies
Session Chair(s)
Kevin Blake, MD, PhD
Clinical Epidemiologist
European Medicines Agency, Netherlands
The session will review the draft European Medicines Agency (EMA) guidance on postauthorization efficacy studies (PAES). PAES can be imposed by European regulators as conditions of a marketing authorization. Hear about when PAES might be required, and what you might need to include.
Learning Objective : Describe the legal mandate for the European Medicines Agency in cooperation with stakeholders to develop scientific guidance on postauthorization efficacy studies; Discuss the approach taken including current thinking on use of clinical trial and observational data and situations in which these studies might be required of pharmaceutical companies in practice.
Speaker(s)
Strategy on Registries
Peter Richard Arlett, MD, FFPM, FRCP
European Medicines Agency, Netherlands
Head Data Analytics and Methods Task Force
Industry Perspective
Emma Du Four, MBA
-, United Kingdom
Regulatory and R&D Policy Professional
European Regulatory Perspective
Álmath Spooner, PhD
AbbVie, Ireland
Head of Europe Regulatory Policy & Intelligence (RPI)
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Ways to register
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