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The implementation of adverse event reporting, signal management and the continuous safety evaluation of veterinary medicinal products by trained and competent personnel is one of the essential requirements of the EU pharmacovigilance legislation and the guidelines on good veterinary pharmacovigilance practice.
All personnel involved in adverse event reporting and signal management should have received specific training according to their role profile.
The objective of this course is to provide an understanding of the requirements for the collection, reporting and recording of suspected adverse events in the Union pharmacovigilance database (EV VET 3, Eudravigilance Veterinary), the various processes and procedures involved in veterinary signal management, data sources for signal management, annual statement submission in the IRIS portal, uploading of sales volumes to the UPD, regulatory inspection and the importance of veterinary pharmacovigilance communication in the benefit-risk assessment process.