On 7 May, the second session of the training capsule series organised by Navarra Health Cluster in collaboration with Asphalion took place. This session focused on post-marketing surveillance activities for medicinal products and medical devices, and was delivered by Laura Eder Azanza, Associate Director of Drug Safety and Deputy EU-QPPV at Asphalion.
More than 30 members of the Navarra Health Cluster took part in the session, demonstrating the cluster members’ interest and commitment to staying up to date with best practices in pharmacovigilance and medical device surveillance.
The training covered key topics such as the legal framework for pharmacovigilance, adverse reaction management, and post-marketing surveillance of medical devices. Pharmacovigilance activities were discussed, including the management of Individual Case Safety Reports (ICSRs), signal detection, Periodic Safety Update Reports (PSURs), and Risk Management Plans (RMPs). In addition, the session addressed specific aspects of medical device surveillance and post-marketing surveillance, such as the interaction between the Post-Market Surveillance (PMS) system and other systems, PMS/PMCF plans and reports, and the management of incidents and Field Safety Corrective Actions (FSCAs).
This session is part of a series of short training modules aimed at providing specialised and up-to-date knowledge to healthcare professionals in Navarra.
We would like to extend our special thanks to CEIN for hosting us and providing the space to carry out this training session. Their support has been key to the success of this initiative and to fostering collaboration among the members of the Navarra Health Cluster.
We hope that these training capsules will continue to be a valuable tool for all healthcare professionals in Navarra, and that they will keep contributing to the development and improvement of monitoring practices for medicinal products and medical devices.
