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Pharmacovigilance activities for human medicinal products as LCP

According to the current legislation and the Good Pharmacovigilance Practice (GVP), the Marketing Authorisation (MA) holder is requested to implement several pharmacovigilance activities with the ultimate purpose of ensuring a continuous control of the safety of the marketed drugs.

Di Renzo Regulatory Affairs has a special unit dedicated to pharmacovigilance, with several experts with appropriate training and experience to assume the role of LCP and Deputy

The main services offered in this field are:

  • Assumption of the role of Local Contact Point for Italy  – including the availability of a Deputy
  • Periodic verification of Italian scientific literature for medicines and active ingredients
  • Medical evaluation of adverse drug reactions
  • Follow-up management
  • Checks of the Italian National Pharmacovigilance Network (RNF)
  • Safety data exchange with business partners and English translation of Italian ICSRs in CIOMS and/or in XML format according to the E2B standard
  • Periodic reconciliation of the cases
  • Drafting, review and updating of safety agreements for the exchange of information (Safety Data Exchange Agreements – SDEA)
  • Periodic training for internal staff of MA Holders/Italian Affiliates on pharmacovigilance and operational procedures
  • Periodic pharmacovigilance training for medical sales representatives (Informatori Scientifici del Farmaco – ISF)