pharmacovigilance

pharmacovigilance

The pressure to ensure drug safety increases every day and effective implementation of Pharmacovigilance procedures is becoming ever more critical for Animal Health companies.  The multilingual and multi-disciplinary veterinary and regulatory team at Triveritas can assist you in keeping up to date and compliant with the latest Pharmacovigilance regulatory requirements and can oversee the complete process on your behalf.
We can offer:

  • compilation of data exchange contracts
  • EU QPPV
  • to receive, process, review and follow-up all adverse event reports
  • pharmacovigilance Standard Operating Procedures tailored to your exact requirements
  • compilation of the Detailed Description of a Pharmacovigilance System for inclusion in Part I of your dossier
  • management of serious adverse events
  • expedited reporting to local authorities and reference member states
  • compilation, review and submission of aggregate reports (e.g. PSURs)
  • signal detection activities and continuing evaluation of the risk/benefit balance
  • pharmacovigilance training
  • maintenance of a safety database and paper records
  • eudravigilance registration consulting
  • surveillance of published literature
  • help with preparation for Pharmacovigilance audits
  • pharmacovigilance in clinical trials of investigational veterinary products