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Session 5: EV Requirements: Where are we now?
Session Chair(s)
Willemijn van der Spuij, MSc
Executive Director, WorldWide Patient Safety International, Europe
Switzerland
This session will provide an opportunity to review experience with EudraVigilance from several perspectives more than one year since launch. The speakers will also explore some of the more pressing practical challenges encountered to-date, including causes and possible mitigation towards preventing duplicate reporting
Speaker(s)
EV Requirements: Inspection Findings (Signalling, Download, Tracking)
Kiernan Trevett, MSc
Genentech, A Member of the Roche Group, United States
Principal Quality Lead, PDQ Quality Assurance Process GVP
Maarten Lagendijk, MSc
MSD, Netherlands
Deputy EU QPPV
Challenges and Approaches to Handling High Volume Downloads
Balwant Heer
Mylan Inc., United Kingdom
VP, Global Head Product Safety & Risk Management, EEA QPPV
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