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Session 2: The New EudraVigilance (EV) System – Where we are now?
Session Chair(s)
Margaret Anne Walters
Deputy EU Qualified Person for Pharmacovigilance
Merck, Sharp & Dohme Ltd, United Kingdom
Major system changes, of which EV is a prime example, inevitably have a settling period during which both technical and procedural issues not seen in testing are likely to arise. The EMA are already aware of many concerns and challenges raised by industry and are addressing them on an urgent basis, plus some more specific challenges can be related to how an MAH has understood and implemented the requirements in their company. This session will review the current situation with respect to ICSR download and (very early) signalling experience, sharing knowledge gained and taking into account perspectives from across Industry (large, small, generics etc.) and Regulators. Additionally, the Panel Discussion will allow participants to directly interact with individuals working on both current issues and future development.
Speaker(s)
Resolving, Ongoing and New Challenges – an ICSR Focus
Sabine Brosch, PharmD, PhD, MPharm
European Medicines Agency, Netherlands
Data Protection Officer
NEW ICSR Processes - The SME Perspective
Elspeth McIntosh, MBA, RN
Castle Pharmacovigilance Ltd, United Kingdom
Director
Initial Experience with the E/V Signal Pilot: Practicalities and Possibilities
Magnus Ysander, MD
AstraZeneca, Sweden
EU & UK QPPV & Head Pharmacovigilance Excellence
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