Farmacovigilanza: Safety Monitoring, Risk Management, Quality Assurance Nella Digital Health Era - Secondo Livello

Pharmacovigilance is an important training and local monitoring activity for the development and use of a drug. It comprises all actions aimed at collecting and assessing information on the safety of drugs on an ongoing basis, including suspected adverse drug reactions (ADR). Based on a continuous review of the drugs? safety profiles, pharmacovigilance determines the application of appropriate precautionary measures, ensuring that not only drugs available on the market, but also those undergoing clinical trials, have a favourable risk-benefit balance for the population, under the authorised conditions of use. In this regard, pharmacovigilance is a fundamental activity to gain better knowledge of drugs, to properly inform doctors prescribing such drugs and protect patients taking them. Pharmacovigilance relies on the close collaboration of all professionals involved, as well as of local, national and international health authorities and pharmaceutical companies, to ensure that the use of drugs remains safe over time.

The programme aims to develop professionals with the necessary theoretical and practical knowledge base regarding risk assessment and monitoring of adverse effects associated with a medical treatment.
Each pharmaceutical company operating on the Italian and European market is required to have a pharmacovigilance service for its products, ensuring continuous safety monitoring, updating of safety information, as well as implementation of risk management and risk minimisation plans.
Moreover, the Italian Medicines Agency (AIFA), under the direction of the Ministry of Health, manages the Italian national pharmacovigilance system and the National Pharmacovigilance Network (RNF) for the collection of spontaneous reports, in collaboration with the Regional Centres of Pharmacovigilance and the Local Pharmacovigilance Managers working at local healthcare authorities (ASL), hospitals and scientific institutes for research, hospitalisation and healthcare (IRCCS).