On November 20, the European Medicines Agency (EMA) hosted its annual meeting for all members of the Patients’ and Consumers’ (PCWP) and Healthcare Professionals’ Working Parties (HCPWP). The meeting began with an introduction by Juan Garcia Burgos (EMA), who welcomed the participants and the co-chairs of the Working Parties, Marko Korenjak (PCWP) and Rosa Giuliani (HCPWP). The meeting covered a variety of important topics related to medicines and medical devices, including regulatory science, digitalisation and AI, shortages, and communications, and kicked off with a recap of some 2024 patient and healthcare professional engagement highlights, delivered by the Head of EMA’s Stakeholders and Communication Division, Melanie Carr. After an update from Ana Zanoletty (EMA) on ongoing clinical trial activities in the EU, Denis Lacombe (EMA) shared key takeaways from the ACT (Accelerating Clinical Trials) EU Multi-stakeholder Platform Annual Meeting, which focused on fostering collaboration between different organisations. Participants were also encouraged to explore the Clinical Trial Information System (CTIS) public portal, which has undergone recent improvements. Francesca Scotti (EMA) presented the updated portal, which features advanced search functionalities, a more user-friendly interface, and the ability to download search results and information on clinical trials. This update aims to make it easier for patients and healthcare professionals to access and navigate clinical trial information.
A new tool designed to help patients and healthcare professionals find clinical trials in the EU was also demonstrated by Ijsbrand van Rooijen (EMA). The tool, a trial map under development, was introduced in response to feedback from patient organisations seeking better access to trial data. The demo aimed to gather feedback before the tool's public launch in 2025. Participants were also informed about the planned 2025 relaunch of clinical data publication on the Clinical Data Portal, which will increase transparency and access to clinical data for research and regulatory purposes. In the area of medical devices, attendees were updated on EMA’s ongoing activities, including expert panel support for orphan medical devices. The meeting also covered the activities of the Big Data Steering Group and the progress of the AI multi-annual workplan (2023-2028), which focuses on the role of artificial intelligence in the medicinal product lifecycle. Luis Pinheiro (EMA) discussed the flexible nature of the workplan, which allows for annual revisions based on feedback and the rapid evolution of AI technologies. Participants were also briefed on the progress of the Union List of Critical Medicines (ULCM), which will be published in December 2024.
The list is vital for tracking the availability of critical medicines such as cancer treatments, antibiotics, and vaccines across the EU. João Ferreira provided an update on the ongoing work to assess the criticality of additional medicines and substances. The meeting also included discussions on medicine shortages and the new communication process for shortages unrelated to safety or efficacy issues. João Ferreira presented the streamlined Medicine Shortages Communication (MSC) template, which will help ensure better communication with healthcare professionals during critical supply shortages. The new MSC process will be piloted starting in October 2024 and is expected to be fully implemented by April-May 2025. EMA’s communication efforts were also highlighted in the final section of the meeting, with Giulia Gabrielli and Laure Herold providing an overview of their work on communicating about medicine shortages. They introduced a new co-created campaign focused on shortage management, as well as a pilot project on Respiratory Syncytial Virus (RSV) that aims to involve more patient and healthcare professional organisations.