Veterinary safety concerns monitoring, evaluating and improving the safety of veterinary medicines, with particular reference to adverse events in animals and human beings related to the use of these medicines.
It also involves collection of information on adverse events due to off-label use and investigations of the validity of the withdrawal period and of potential environmental problems.
Veterinary safety reports and human drug safety reports owing to veterinary product reactions can be tracked with a robust system that allows data to be generated in XMLs, FDA 1932 report format and in CVMP report formats.
Why PvVET?
PvVET offers a comprehensive veterinary safety reporting system that is compliant with the CVMP and VICH specifications. Through PvVET, veterinary drug manufacturers collect, assess, and report adverse events in accordance with the regulatory obligations. With full electronic reporting, PvVET offers an easy way to comply with the latest regulations.
PvVET also offers
- Provision to generate different report outputs
- Evaluate the data by allowing different workflow reviews
- Managing safety submissions by tracking of expedited timelines
- Generate draft and final outputs
- Reports to track the cases as listings and tabulations
- Dynamic dashboard to know the submission due timelines
- Querying of cases and copy cases option available
- User-friendly system for safety reporting along with audit trail for capturing history
- Ready for VedDRA support
- PSUR report preparation