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Pharmacovigilance activities for human medicinal products as EUQPPV

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 EUQPPV and Deputy.

The main services offered in this field are:

  • Assumption of the role of European Qualified Person for Pharmacovigilance (EU-QPPV) – including the availability of a Deputy
  • Screening for adverse reactions in EudraVigilance and case management
  • Periodic verification of Italian and international scientific literature for medicines and active ingredients
  • Medical evaluation of adverse drug reactions
  • Follow-up management
  • Activities related to the Italian National Network of Pharmacovigilance (RNF)
  • Data Entry and Quality Control of the ARD reports (ICSR) in the safety database
  • Submission of ICSRs to Competent Authorities (Eudravigilance)
  • Safety data exchange with business partners and English translation of Italian ICSRs in CIOMS and/or in XML format according to the E2B standard
  • Insertion and updates of medicines in the EMA database Extended EudraVigilance Medicinal Product Dictionary (XEVMPD)
  • Preparation of the Periodic Safety Update Report (PSUR)
  • Preparation of the Risk Management Plan (RMP)
  • Preparation and maintenance of the Pharmacovigilance System Master File (PSMF)
  • Drafting, review and updating of safety agreements for the exchange of information (Safety Data Exchange Agreements – SDEA)
  • Periodic review of safety data
  • Signal Analysis
  • Insertion of the back log of ADRs in the safety database
  • Pharmacovigilance Due Diligence following the extension of the company’s product portfolio by purchase from other MA holders
  • 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)