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SESSION 1: OPERATIONAL EXPERIENCE WITH EUDRAVIGILANCE (PART I)
Session Chair(s)
Sabine Brosch, PHARMD, PHD, MPHARM
Data Protection Officer
European Medicines Agency, Netherlands
Anja Van Haren, MSC
Eudravigilance coordinator
Medicines Evaluation Board (MEB), Netherlands
This session provides an overview of the initial experience gained with the operation of the new and enhanced EudraVigilance system as well as the use of the new ICH E2B(R3) ICSR format. Aspects addressed will include an overview of data processed and accessed so far as well as key features of release 5 of EudraVigilance. Lessons learned in using the new ICSR format will be shared. Process related aspects in the context of the EudraVigilance download of ICSRs will be discussed based from a MAH perspective. The panel will be available to address questions from the audience.
Speaker(s)
EudraVigilance achievements to date and next steps
Francois Domergue
European Medicines Agency, Netherlands
EV Auditable Requirement Project Manager, Business Data and Analytics Department
Operational experience with EudraVigilance – a MAH perspective
Margaret Anne Walters
Merck, Sharp & Dohme Ltd, United Kingdom
Deputy EU Qualified Person for Pharmacovigilance
Implementing the ISO/ICH E2B(R3) standard in a pharmacovigilance system – challenges and lessons learned
Claudia M. Lehmann
Boehringer Ingelheim Pharma GmbH & Co KG, Germany
Head Global Pharmacovigilance Operations
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