Pharmacovigilance: Safety Monitoring, Risk Management and Quality Assurance in the Digital Health Era

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).