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Pharmacovigilance- Medicinal products for human use

The core services offered in this area by Di Renzo Regulatory Affairs are as follows:

  • Assuming the role of QPPV (Qualified Person Responsible for Pharmacovigilance), Local Contact Point and Deputy
  • Availability over 24 hours
  • Contacts with the Italian Drug Agency (AIFA), the European Medicines Agency (EMA), the Coordination Group for Mutual Recognition and Decentralized Procedures - Human (CMDh) and with all partners involved
  • Daily monitoring of the National Network of Pharmacovigilance (RNF) of the AIFA
  • Monitoring of national and international literature, both for the product and the active substance
  • Management of reports, requests for follow-ups, preparation of CIOMS and medical evaluation of Adverse Drug Reactions (ADRs)
  • Insertion of Individual Case Safety Reports (ICSRs) in the Drug Safety database and National Network of Pharmacovigilance (RNF) / EudraVigilance
  • Pharmacovigilance training for companies
  • Preparation, maintenance and updating of the Pharmacovigilance System Master File (PSMF)
  • Preparation of the quality system, preparation of internal Standard Operating Procedures (SOPs) and audits
  • Data entry
  • Preparation of Periodic Safety Update Reports (PSURs)
  • Preparation of the Risk Management Plans (RMPs)
  • Drafting, reviewing and updating of Safety Data Exchange Agreement (SDEA)