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Session 2: EudraVigilance access by MAHs – Tools for Signal Detection and Validation
Session Chair(s)
Sabine Brosch, PHARMD, PHD, MPHARM
Data Protection Officer
European Medicines Agency, Netherlands
Sabine Straus, MD, PHD, MSC
Former PRAC Chair
Medicines Evaluation Board (MEB), Netherlands
This session will provide an overview of the EudraVigilance access and data provided to MAHs via the EudraVigilance Data Analysis System (EVDAS) together with the tools and statistical method to support signal detection and validation. The provision of level 2b access through EudraVigilance WEB trader (EVWEB) which includes the case narratives will also be demonstrated.
Speaker(s)
The MAH Pharmacovigilance queries dashboard: Principles of the EVDAS access for MAHs and EVDAS reports
Gianmario Candore
European Medicines Agency, Netherlands
Data Scientist
The MAH Pharmacovigilance queries dashboard: Principles of the EVDAS access for MAHs and EVDAS reports
Rodrigo Postigo
European Medicines Agency, Netherlands
Signal Management Lead, Pharmacovigilance Office
Level 2b access: How to retrieve the case narratives (live demonstration) in EVWEB
Nick Halsey
European Medicines Agency, Netherlands
Scientific Administrator
The electronic Reaction Monitoring Report (eRMR): Tool for signal detection in EudraVigilance
Cosimo Zaccaria
European Medicines Agency, Netherlands
Signal Management Lead, Pharmacovigilance Department