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Pharmacovigilance - Medicinal products for veterinary use

In this area Di Renzo Regulatory Affairs is able to offer the following services:

  • Assuming the role of QPPV (Qualified Person Responsible for Pharmacovigilance)
  • Handling relations with the company, the Ministry of Health, the European Medicines Agency (EMA) and all concerned national and international organizations
  • Management of Adverse Drug Reactions (ADRs), requests for follow-ups of ADRs, preparation of CIOMS, medical evaluations
  • Periodic searches of cases in national and international scientific literature
  • Preparation of Periodic Safety Update Reports (PSURs)
  • Training for company personnel
  • Preparation of the quality system, preparation of internal Standard Operating Procedures (SOPs) and audit
  • Continuous availability