HMA/EMA – A Joint Heads of Medicines Agencies (HMA)/European Medicines Agency (EMA) multistakeholder workshop on Patient Registries for Alzheimer’s disease will be held the 15 December 2025

Summary of the event:

This joint hybrid HMA/EMA Patient Registries workshop aims to facilitate the long-term follow up of medicines for Alzheimer’s Disease (AD), and enable the generation of meaningful safety and efficacy/effectiveness data using existing patient registries.

The event will bring together representatives of registry holders, regulatory agencies, pharmaceutical companies, patients, healthcare professionals, academia, and health technology assessment bodies to address the following objectives:

• To raise awareness on the evidence gaps on current and upcoming therapies that could be – at least partly – addressed via the use of real-world data (RWD). This will include aspects on specific safety and efficacy/effectiveness considerations including risk minimisation measures, and on the need for long-term follow-up data on treated patients.
• To agree on recommendations on core data elements to be collected to permit the evaluation of the safety and efficacy/effectiveness of individual therapies, but also the comparison between therapies, as well as the evaluation of the effectiveness of imposed risk minimisation measures.
• To agree on recommendations on patient consent, governance for accessing and sharing data, quality assurance and registry interoperability.
• To agree on recommendations to optimise collaboration among registry holders, marketing authorisation holders or applicants (MAHs/MAAs) and regulators to facilitate the long-term follow up of AD products in a real world setting and enable the generation of meaningful safety and efficacy/effectiveness data using existing or upcoming registries.

More information on the EMA Website.

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