The Joint Heads of Medicines Agencies (HMA)/European Medicines Agency (EMA) Multistakeholder workshop on Patient Registries 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:
- 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.
In person participation is organised via EU associations and direct invitations to allow a broad range of stakeholders to participate.
The Day 2 plenary sessions of the workshop will also be broadcast via the EMA corporate website. Registration is not required to follow the event online. A video recording of the Day 2 plenary sessions will be available after the event.