Key Features/Benefits

  • Complies with CVMP and VICH reporting requirements
  • Provides full electronic reporting
  • VedDRA support
  • PSUR report preparation

Background

As with human drug development, the safety of animals is a high concern for the major regulatory agencies.  As such there are also stringent rules for the collection and reporting of adverse event data and all veterinary drug manufacturers are required to comply.  The rules are also complex and recently they have been updated to support electronic reporting.

LifeSphere Vet Safety - Veterinary Safety Reporting

LifeSphere Vet Safety is a comprehensive veterinary safety reporting system that is compliant with the CVMP and VICH specifications.  Through LifeSphere Vet Safety, veterinary drug manufacturers and collect, assess and report adverse events in accordance with the regulatory obligations.  With full electronic reporting, LifeSphere Vet Safety offers an easy way to comply with the latest regulations.

adverse event reporting software