HMA/EMA – Joint Heads of Medicines Agencies (HMA)/European Medicines Agency (EMA) multistakeholder workshop on Patient Registries for Alzheimer’s disease will be held the 15th December
This joint hybrid HMA/EMA workshop on Patient Registries follows on the successful disease-specific workshops held between 2017 and 2019, as well as the EMA multi-stakeholder workshop on qualification of Patient Registries held in 2024.
The event will bring together representatives of registry holders, regulatory agencies, pharmaceutical companies, patients, healthcare professionals, academia and non-for-profit research organisations, health technology assessment bodies and payers to explore how we can work all together 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.
Specific objectives of the day:
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To raise awareness of the evidence gaps related to current and upcoming therapies that could potentially be addressed using real-world data (RWD).
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To agree on recommendations for core data elements to be collected in registries to enable the evaluation of therapies, and the effectiveness of their risk minimisation measures.
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To agree on recommendations regarding patient consent, governance for accessing and sharing data, quality assurance and registry interoperability.
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To agree on recommendations for optimising stakeholders’ collaboration to facilitate the long-term follow-up of patients using registries, and enable the generation of meaningful data for regulatory decision-making.
More information of the event page on the EMA Website.
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vroby (22 novembre 2025). HMA/EMA – Joint Heads of Medicines Agencies (HMA)/European Medicines Agency (EMA) multistakeholder workshop on Patient Registries for Alzheimer’s disease will be held the 15th December. ELSIBI. Consulté le 19 janvier 2026 à l’adresse https://doi.org/10.58079/156rr





