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Session 2: Hot Topics – Industry Perspectives, What Do I Need to Know?
Session Chair(s)
Vicki Edwards, RPh
Vice President, Pharmacovigilance Excellence and International QPPV
Abbvie, United Kingdom
This will be year four for this very popular session. Typically the session invites speakers who are leading discussions between industry trade associations and Regulatory Authorities on the key issues of the moment. The session provides insight into what are the hot topics under discussion, what progress has been made and what are the next steps. The session is of value to participants from both large and small companies alike as there is limited attendance possible at the public meetings with EMA so this is a fantastic opportunity to hear about these topics from individuals who are directly involved. The session consists of a series of short, concise presentations that cover the key messages. This session is always a crowd pleaser!
Speaker(s)
Update on collection of safety data from PSPs
Sue Rees, MS
Sue Rees Consultancy Ltd, United Kingdom
Director
Update on EV new functionalities
Margaret Anne Walters
Merck, Sharp & Dohme Ltd, United Kingdom
Deputy EU Qualified Person for Pharmacovigilance
Update on RSI
Willemijn van der Spuij, MSc
Switzerland
Executive Director, WorldWide Patient Safety International, Europe
Country level signal notification requirements
Willemijn van der Spuij, MSc
Switzerland
Executive Director, WorldWide Patient Safety International, Europe
EV Signalling Metrics
Valerie E. Simmons, MD, FFPM
Eli Lilly and Company Ltd, United Kingdom
Senior Medical Fellow, Global Patient Safety
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