Pharmacovigilance services in Italy

If you are a pharmaceutical manufacturer, healthcare provider, or life sciences organization operating in Italy, explore pharmacovigilance services in Italy to ensure drug safety and regulatory compliance. From adverse drug reaction reporting to compliance with AIFA pharmacovigilance regulations, the right PV partner shapes everything: signal detection, risk management planning, safety reporting, and successful market authorization.

Expert Pharmacovigilance Services for the Italy Market

The Italian Ministry of Health and the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA) are responsible for overseeing all regulatory and pharmacovigilance services for pharmaceutical products in circulation in the country. AIFA is the national authority responsible for drug regulation in Italy. AIFA collaborates with other organizations and committees: the National Institute of Health, research institutes, patient associations, healthcare professionals, scientific societies, the pharmaceutical industry, and distributors. The mission of AIFA in pharmacovigilance is to ensure a favourable risk/benefit ratio for all authorised drugs through continuous monitoring of all safety information and adverse drug reactions (ADRs). Marketing Authorisation Holders (MAHs) must appoint a Qualified Person Responsible for Pharmacovigilance (QPPV) for ADR report management. All reports of adverse reactions are merged into the European database EudraVigilance. This activity is aimed at the identification of changes in risk or new risks through signal analysis. Although Italy has a good system and robust structure, there exist significant differences between regional and local activities. Physicians and healthcare professionals are required to report all suspected serious or unexpected ADRs which they learn from their activity in order to improve the system.

• + ICSR Processing & Submission
  • Triage of initial and follow-up ICSRs, SUSARs
  • Case processing through E2B(R3)-compliant databases and other relevant databases integrated with WHO DD and MedDRA
  • Quality check, medical reviews
  • Submission of cases as per agency timelines
  • Maintaining ICSR monitoring & tracking sheets
  • Reconciliation processes with customers
• + Risk Management Plan (RMP)
  • Drafting, reviewing, and maintaining RMPs and REMS with support through submission methods
  • Preparing customised procedures to classify safety risks and deliver tailored risk management strategies
  • Assessment of potential risks and missing information; preparing reports that recommend risk minimization methods
  • Implementation of supplementary measures, including Post-Authorization Safety Studies (PASS), observational examinations, and follow-up questionnaires
  • Conveying risks through labelling: Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL)
• + Aggregate Reports
  • Periodic Safety Update Reports (PSURs)
  • Development Safety Update Reports (DSURs)
  • Annual Safety Reports (ASRs)
• + Signal Management
  • Identification of new safety signals or changes in risks from ICSR databases, literature, aggregate reports , and regulatory agency website monitoring
  • Use of in-house tools and databases for signal detection and tracking
  • Review safety signals and recommendations by PRAC (Pharmacovigilance Risk Assessment Committee)
  • Perform label update analysis
  • Provide recommendations from signal assessments including risk minimisation approaches
  • Preparation of Signal Management Trackers, Annual Signal Reports
• + Qualified Person Responsible for Pharmacovigilance (QPPV)
  • Review of Pharmacovigilance System Master File (PSMF), Safety Data Exchange Agreements (SDEAs), agreements with commercial partners, Pharmacovigilance Standard Operating Procedures (SOPs), etc.
  • Review of PSMF, SDEA agreements, agreements with commercial partners, PV SOPs etc.
  • Review & sign-off of aggregate reports, signal reports, and RMPs
  • Retainer services for QPPV services and deputy
  • Local Safety Responsible functions
  • Monthly reconciliation
  • Medical review of signal detection; signal surveillance meetings (quarterly)
  • Monthly communication report / provision of compliance metrics
  • PV Quality Management System oversight
• + PV Audit & Compliance
  • Review compliance audits to applicable PV guidelines, regulations, Safety Data Exchange Agreements (SDEAs), SOPs, and work instructions
  • Optimise well-constructed audit plans and conduct mock audits to prepare organizations for PV inspections by the competent authority (AIFA)
  • Regular gap assessments of PV staff at site location
  • Provide organizational training on safety audits and inspections