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Session 6: Europe Region Updates
Session Chair(s)
Stella Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP
Strategy
Consultant, United Kingdom
Sarah Vaughan
Head of Vigilance Operations
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Brexit, if it happens/has happened, will make an impact on how the EU authorization and pharmacovigilance system operates in the region. The move to Amsterdam has already had a significant effect on EMA resources including loss of both people and expertise. At the same time, all regulators are reacting to the ongoing challenges which are happening outside of this. This session will provide an update on recent events in the European region and how this is affecting the EU regulatory system from different viewpoints of an EMA regulator, UK regulator, and the European Pharmaceutical Industry.
Learning Objective : At the conclusion of this session, participants should be able to:- Know the changes occurring in the broader European region
- Comprehend the implications
- Understand the effects and challenges of these on different stakeholders
Speaker(s)
An EMA Perspective on What is Happening in Europe
Hans-Georg Eichler, MD, MSc
Austrian Association of Social Security Bodies, Austria
Consulting Physician
A UK Perspective on What is Happening in Europe
Sarah Vaughan
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Head of Vigilance Operations
An EFPIA Perspective on What is Happening in Europe
Vicki Edwards, RPh
Abbvie, United Kingdom
Vice President, Pharmacovigilance Excellence and International QPPV