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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
Merck, Sharp & Dohme Ltd, United Kingdom
Deputy EU Qualified Person for Pharmacovigilance
Medical Literature Monitoring
Tom Paternoster-Howe, MSc
European Medicines Agency, Netherlands
Scientific Administrator, Data Analytics & Methods, Task Force, Healthcare Data
EudraVigilance
Francois Domergue
European Medicines Agency, Netherlands
EV Auditable Requirement Project Manager, Business Data and Analytics Department
Article 57 Database of Medicinal Products
Ana-Silvia Cochino
European Medicines Agency, Netherlands
Scientific Administrator
PSUR Repository
Ana Zanoletty Perez
European Medicines Agency, Netherlands
Head of Clinical Trials Transformation Workstream
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