EMA/HMA – Joint Heads of Medicines Agencies HMA/EMA Multistakeholder workshop on Patient Registries: the report and materials of the event are now available

The EMA published the report, the presentation materials and the video recording of the Joint Heads of Medicines Agencies (HMA)/European Medicines Agency (EMA) Multistakeholder workshop on Patient Registries held the 12 and 13 February 2024.

Summary of the event

This joint two-day hybrid HMA/EMA workshop on Patient Registries followed on the successful disease-specific workshops held between 2017 and 2019, as well as the EMA multi-stakeholder workshop on qualification of novel methodologies.

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

• Day 1 – 12 February afternoon: Discuss the EMA qualification procedure for patient registries with the aim to clarify the benefits, identify current limitations, and propose measures to optimise the process;
• Day 2 – 13 February all day: Establish the value and enable the use of patient registries for regulatory decision-making by considering contexts of use for which registry data are ‘fit for purpose’, and examining tools to support data discoverability and assessment.

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