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Session 1: EudraVigilance
Session Chair(s)
Sabine Brosch, PharmD, PhD, MPharm
Data Protection Officer
European Medicines Agency, Netherlands
This session gives insight into the EudraVigilance functionalities to be audited in accordance with Article 24 of Regulation (EC) 726/2004 and a status update on the preparations for the literature monitoring activities by the Agency in line with Article 27 of the Regulation.
Speaker(s)
EudraVigilance functionalities to be audited
Sabine Brosch, PharmD, PhD, MPharm
European Medicines Agency, Netherlands
Data Protection Officer
EudraVigilance functionalities to be audited
Nick Halsey
European Medicines Agency, Netherlands
Scientific Administrator
Status update on the monitoring of medical literature and the entry of relevant information into EudraVigilance
Steven Le Meur
European Medicines Agency, Netherlands
Scientific Administrator
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