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Pharmacovigilance and Risk Management Strategies Conference


Session 6: Europe Region Updates

Session Chair(s)

Stella  Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP

Stella Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP

  • Vice President, Global Head of Early Access and Risk Management
  • IQVIA, United Kingdom
Sarah  Vaughan

Sarah Vaughan

  • Pharmacovigilance Information Unit Systems Manager
  • 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)

Hans-Georg  Eichler, MD, MSc

An EMA Perspective on What is Happening in Europe

Hans-Georg Eichler, MD, MSc

  • Senior Medical Officer
  • European Medicines Agency, Netherlands
Sarah  Vaughan

A UK Perspective on What is Happening in Europe

Sarah Vaughan

  • Pharmacovigilance Information Unit Systems Manager
  • Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Vicki  Edwards, RPh

An EFPIA Perspective on What is Happening in Europe

Vicki Edwards, RPh

  • Vice President, Pharmacovigilance Excellence and QPPV
  • AbbVie, Inc., United Kingdom