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Session 6 QPPV Oversight - PV system updates
Session Chair(s)
Margaret Anne Walters
Deputy EU Qualified Person for Pharmacovigilance
Merck, Sharp & Dohme Ltd, United Kingdom
EMA have several major deliverables scheduled throughout 2015 to support business activities of the revised pharmacovigilance legislation, including implementation of the Article 57 database, EMA Medical Literature Monitoring, the PSUR repository and Eudravigilance auditable activities. In line with implementation of these projects, QPPVs will need to ensure through oversight and/or input that company systems are enabled to meet these requirements in a timely fashion, and this session will focus on challenges and success factors for business change. In addition, this session will look to explore the role of the EU QPPVs and that of the National PV Responsible person(s) – together with Inspector expectations and experience with respect to interactions between these roles.
Speaker(s)
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
Ilaria Del Seppia
European Medicines Agency, Netherlands
Scientific Administrator, Data Standardisation and Analytics Department
PSUR Repository
Irene Rager
European Medicines Agency, Netherlands
Head of Service E, Procedure Management Department
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