Local Responsible for Pharmacovigilance/Local Contact Point
Under the provisions of Directive 2001/83/EC, as amended, Competent Authorities in individual EU Member States may require the appointment of a Local Responsible for Pharmacovigilance/Local Contact Point to manage pharmacovigilance activities at national level, working in close collaboration with the EU Qualified Person Responsible for Pharmacovigilance (EU-QPPV). Consequently, the requirement for such an appointment remains at the discretion of each EU Member State.
In Italy the appointment of an Local Responsible for Pharmacovigilance/Local Contact Point is necessary for the execution of all national pharmacovigilance activities. These processes are conducted in Italian and managed through the National Pharmacovigilance Network (RNF) of the Italian Medicines Agency (AIFA).
UK legislation mandate that Marketing Authorization (MA) Holders of UK-authorized medicinal products must have a UK Qualified Person Responsible for Pharmacovigilance (UK-QPPV) who resides and operates within the UK or the EU/EEA, responsible for the establishment and maintenance of the pharmacovigilance system. Furthermore, if the UK-QPPV is based outside the UK, the MA Holder is required to appoint a “National Contact Person for Pharmacovigilance in the UK.”
Our Solutions
Di Renzo Regulatory Affairs operates a specialized pharmacovigilance unit, comprising highly trained experts qualified to act as Local Responsible for Pharmacovigilance/Local Contact Point and Deputies in Italy.
Leveraging our international reach and a robust network of consultants across EU and non-EU territories, we enable Companies to establish a dedicated pharmacovigilance network. By integrating Local Responsible for Pharmacovigilance/Local Contact Points within the specific markets of interest, we provide a tailored solution customized to the product portfolios and the jurisdictions in which they are authorized.
Our core service offerings include:
- Acting as Local Responsible for Pharmacovigilance/Local Contact Point for Italy – including the provision of Deputy support
- Management of the entire pharmacovigilance quality system and assuming the role of Pharmacovigilance Quality Assurance Responsible
- Periodic screening of national scientific literature for medicinal products and active substances
- Medical assessment of adverse drug reaction (ADR) reports
- Follow-up management
- Exchange of safety data with commercial Partners and translation into English of Italian ICSRs in CIOMS format and/or in XML format in accordance with the E2B standard
- Periodic case reconciliation
- Drafting, reviewing, and updating Safety Data Exchange Agreements/Pharmacovigilance Agreements (SDEAs/PVAs).
- Periodic training for the internal staff of the MA Holder on pharmacovigilance, on the methods of sharing any adverse reaction reports and on the applicable pharmacovigilance procedures
- Periodic training for sale force on pharmacovigilance and on the methods of sharing any adverse reaction reports