Good Vigilance Practice
The safety and efficacy of a veterinary medicinal product continue to be monitored after authorisation. This seminar covers the fundamentals of veterinary pharmacovigilance and explains how suspected adverse events are recorded, safety signals assessed and risk-minimisation measures developed where appropriate.
Seminar content
- Legal and regulatory framework for veterinary pharmacovigilance
- Veterinary Good Pharmacovigilance Practices (VGVP)
- The pharmacovigilance system and Pharmacovigilance System Master File (PSMF)
- Responsibilities of the Qualified Person Responsible for Pharmacovigilance (QPPV)
- Recording and assessment of adverse events
- Union Pharmacovigilance Database and EudraVigilance Veterinary (EVVet)
- Signal detection, validation and evaluation
- Continuous signal management
- Risk-minimisation measures and risk communication
- Pharmacovigilance inspections
Post-authorisation pharmacovigilance
Because clinical trials involve limited numbers of subjects, they cannot always detect rare adverse events. That is why veterinary medicinal products continue to be monitored after authorisation. Reports and other safety information are assessed to identify new signals and continually evaluate the benefit-risk balance.
Since 2022, the focus has been on continuous signal detection and assessment; the former periodic safety update reports (PSURs) for veterinary medicinal products have been replaced by continuous signal management.
This seminar provides a practical overview of the pharmacovigilance system for veterinary medicinal products, from recording adverse events and managing signals to benefit-risk assessment and regulatory action. You will learn about the key tasks, responsibilities and electronic systems used in veterinary pharmacovigilance.