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