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 , 16:00 - 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 facilitate the long-term follow-up of patients with Alzheimer’s Disease (AD), and to enable the generation of meaningful evidence using patient registries on the safety and effectiveness of medicines.

Specific objectives of the day:

• To raise awareness of the evidence gaps related to current and upcoming therapies that could potentially be addressed using real-world data (RWD).
• 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.
• To agree on recommendations regarding patient consent, governance for accessing and sharing data, quality assurance and registry interoperability.
• 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. 
   

Documents

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

Draft

Registration

To attend this event in person or online via Webex, registration is required. 

Please register using this link: Joint HMA/EMA Multi-stakeholder workshop on Patient Registries for Alzheimer's Disease - 15 December 2025

• The deadline for in-person participation is close of business on 27 October. 
  Expenses reimbursement might be possible on a case-by-case basis.
  Due to room capacity constraints, in-person participation will be on invitation only. A selection will be made by EMA based on information provided by individuals on their experience working with Alzheimer's Disease registries. This is to ensure a diverse audience with sufficient expertise and to facilitate discussions. Individuals not selected for in-person attendance will still have the possibility to join the meeting online via Webex for active oral participation.
   
• The deadline for online active participation to the plenary and breakout sessions via Webex is close of business on 28 November.

The workshop’s plenary sessions are broadcast live from this webpage. If you would only like to listen to the discussions, please follow the live broadcast. In this case, registration via the form is not required.

Video recording

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