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Session 7 QPPV Oversight – Change Management in line with Pharmacovigilance System Updates
Session Chair(s)
Margaret Anne Walters
Deputy EU Qualified Person for Pharmacovigilance, Merck, Sharp & Dohme Ltd, United Kingdom
Sabine Brosch, PharmD, PhD, MPharm
Data Protection Officer, European Medicines Agency, Netherlands
The EMA have major deliverables scheduled in 2016/2017 to support impending key business changes under the revised PV legislation. This session will provide updates followed by a panel discussion with key EMA speakers towards better enabling effective QPPV oversight of timely and effective internal implementation.
Speaker(s)
Introduction from the MAH Perspective
Margaret Anne Walters
Deputy EU Qualified Person for Pharmacovigilance, Merck, Sharp & Dohme Ltd, United Kingdom
Medical Literature Monitoring
Tom Paternoster-Howe, MSc
Scientific Administrator, Data Analytics & Methods, Task Force, Healthcare Data, European Medicines Agency, Netherlands
EudraVigilance
Francois Domergue
EV Auditable Requirement Project Manager, Business Data and Analytics Department, European Medicines Agency, Netherlands
Article 57 Database of Medicinal Products
Ana-Silvia Cochino
Scientific Administrator, European Medicines Agency, Netherlands
PSUR Repository
Ana Zanoletty Perez
Head of Clinical Trials Transformation Workstream, European Medicines Agency, Netherlands
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