Joint Heads of Medicines Agencies (HMA)/European Medicines Agency (EMA) multistakeholder workshop on Patient Registries for Alzheimer's disease

• Date:
  Monday, 15 December 2025 , 09:00 - 12:00 Amsterdam time (CET)
  Monday, 15 December 2025 , 13:00 - 17:30 Amsterdam time (CET)
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands
  Live broadcast

Event summary

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 brings 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 foster the use of registry data for regulatory decision-making in the field of Alzheimer’s Disease.

More specifically, the main objectives of the workshop are 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 evidence on the safety and effectiveness of medicines using patient registries. These objectives will be addressed by:

• Raising awareness of the evidence gaps related to current and upcoming therapies that could potentially be addressed using real-world data (RWD).
• Identifying core data elements to be collected in registries to enable the evaluation of therapies, and the effectiveness of their risk minimisation measures.
• Aligning on recommendations regarding patient consent, governance for accessing and sharing data, quality assurance and registry interoperability.

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Note: In according with the EMA Guideline on registry-based studies, “Patient registry” (referred to as “registry” in the rest of the agenda) is defined as: Organised system that collects uniform data (clinical and other) to identify specified outcomes for a population defined by a particular disease, condition or exposure. The term ‘patient’ highlights the focus of the registry on health information. It is broadly defined and may include patients with a certain disease, pregnant or lactating women or individuals presenting with another condition such as a birth defect or a molecular or genomic feature.

Documents

Programme - Joint HMA/EMA multi-stakeholder workshop on Patient Registries December 2025

Draft

Registration

The deadline for online participation is 28 November close of business.

Please complete the following form to receive the connection details: Joint HMA/EMA Multi-stakeholder workshop on Patient Registries for Alzheimer's Disease - 15 December 2025

The registration for in-person participation is now closed. Face-to-face attendance is by invitation only.

Video recording

A video recording of the plenary sessions is made available after the event.