The Italian Medicines Agency organised the training course on the new National Pharmacovigilance Network (RNF), which is the system by which reports of suspected adverse drug reactions (ADRs) are collected, managed and analysed in Italy.

The course, which was held in Rome on 24, 25 and 26 May 2022, was attended in presence and via streaming by over 500 Pharmacovigilance Managers and their collaborators working at Regions, Regional Centres, Hospitals, IRCSS and ASLs.

The speakers' speeches focused on the presentation of all the functionalities of the new RNF, which will be active from 20 June 2022 and in which the international standard ISO Individual Case Safety Report (ICSR) ICH E2B(R3) format will be implemented for the reporting of suspected adverse drug reactions as provided for in Article 26(2)(a) of the Implementing Regulation (EU) No 520/2012.

he new RNF will feature advanced functions for the management and analysis of suspected adverse reaction reports to ensure an increasingly accurate assessment of the safety profile of medicines.

During the course, all transition measures that will be implemented during the period of transition from the current system to the new RNF were also explained.

As of 30 June 2022, the use of the new international ISO ICSR standard will become mandatory in all EU countries for sending and receiving reports of suspected adverse reactions to and from the EudraVigilance System, the European database of suspected adverse reactions to medicinal products authorised or under investigation in the European Economic Area (EEA), with which the RNF is closely linked.

The new RNF is the result of years of intense teamwork, which required the involvement of the Italian Medicines Agency's top pharmacovigilance and information technology experts.

The event also provided an important opportunity for the Agency to exchange views with all the Pharmacovigilance Managers operating in the various Italian regions, who contribute through their activities to ensuring the continuous monitoring of reports of suspected adverse drug reactions, thus guaranteeing the safety of medicines on the market.

Published on: 26 May 2022