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Session 1 Key Note
Session Chair(s)
Michael Richardson, MD, FFPM, FRCP
Senior Vice President, WorldWide Patient Safety
Bristol-Myers Squibb, United Kingdom
The EU PV legislation, which came with clearly defined objectives, has been in force since 2012. This session will ask key Regulators the following questions: Has the implementation been achievable, practical and complete? Have the deliverables of transparency, simplification and enhanced evaluation of benefit risk been achieved? Are the regulators gaining better oversight and insight to the use of medicines within Europe and have Patients and Healthcare providers received better and clearer information on the products they use. Are industry and regulators better able to collaborate and communicate in the oversight of the use of medicines and does the QPPV have greater oversight of the safety of the products for which they have responsibility?
Speaker(s)
Update on Three-Years of Operation of the new EU Pharmacovigilance System
Peter Richard Arlett, MD, FFPM, FRCP
European Medicines Agency, Netherlands
Head Data Analytics and Methods Task Force
SCOPE: Standards of collaboration to Operate Pharmacovigilance in Europe
Mick Foy
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Director of Delivery
Industry Perspective - Building on 3 Years of EU Pharmacovigilance Legislation
Michael Richardson, MD, FFPM, FRCP
Bristol-Myers Squibb, United Kingdom
Senior Vice President, WorldWide Patient Safety
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