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Pharmacovigilance Services

Regulatory Pharma Net

RPN offers comprehensive services within the pharmacovigilance area, from system establishment to daily maintenance activities.

Pharmacovigilance System Master File (PSMF)

  • Gap analysis of the company pharmacovigilance system
  • SOPs preparation
  • PSMF preparation
  • PSMF maintenance (planning and management)

Pharmacovigilance system maintenance activities (local and EU level)

  • Registration of a RPN representative in the ‘Rete nazionale di Farmacovigilanza’ (RNF) as local contact person who refers to the EU QP PV
  • Regular check of any report of suspected adverse drug reaction (ADR) entered into the Italian database by the people responsible for pharmacovigilance at local health authorities/hospitals
  • Regular check of any communication received from the Italian Agency through the database; check of the local literature and data entry of any Italian serious literature case into the system
  • Request for additional details/follow-up on a report entered through the database
  • English translation of reports which occur in the Italian territory and generation of CIOMS
  • Management of EudraVigilance (RPN is certified for ICSRs reporting and XEVMPD)
  • PSURs preparation and submission
Quick Contact Pharmacovigilance Services