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Session 2: Hot Topics for QPPV Oversight
Session Chair(s)
Vicki Edwards, RPh
Vice President, Pharmacovigilance Excellence and International QPPV
Abbvie, United Kingdom
This will be year five 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)
EFPIA updates related to Pharmacovigilance (RWE)
Vicki Edwards, RPh
Abbvie, United Kingdom
Vice President, Pharmacovigilance Excellence and International QPPV
ICH E19 – Optimisation of Safety Data Collection
Guy Demol
MSD, Belgium
EU QPPV
ICH E2D – Post-Approval Safety Data Management
Sue Rees, MS
Sue Rees Consultancy Ltd, United Kingdom
Director
EFPIA International Groups Achievements
Willemijn van der Spuij, MSc
Switzerland
Executive Director, WorldWide Patient Safety International, Europe
Medical Device Regulation & Risk Management Planning
Magnus Ysander, MD
AstraZeneca, Sweden
EU & UK QPPV & Head Pharmacovigilance Excellence
Reference Safety Information
Judith Weigel, MSc
vfa - Association of Research-Based Pharmaceutical Companies, Germany
Pharmacist, Pharmacovigilance/ Interface Regulatory Affairs,
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