The EMA has recently updated two key resources for veterinary pharmacovigilance:
1- Veterinary Union Pharmacovigilance Database – Best Practice Guide (v13)
2- Veterinary Signal Assessment Report Template (rev.2)
These updates provide practical guidance for all registered organisations and users submitting suspected adverse event reports in EudraVigilance Veterinary (EVV). Highlights include:
- Standardised signal reporting for all types of validated signals
- Detailed instructions for each section of the assessment report
- Mandatory analysis dates and EVV query references
- Standardised conclusions for consistent assessments
The updated Best Practice Guide also offers practical advice on implementing VGVP modules, including signal management, adverse event collection, and inspections, all integrated with EMA digital systems (IRIS and EVV Data Warehouse).
At Asphalion, we help veterinary organisations navigate these updates efficiently, ensuring compliance, accurate reporting, and smooth signal management. Let us help you streamline your pharmacovigilance processes and stay ahead of regulatory expectations. Contact us! [email protected]
