Joint Heads of Medicines Agencies (HMA)/European Medicines Agency (EMA) Multistakeholder workshop on Patient Registries
Event
Human
Corporate
Medicines
Date
- Monday, 12 February 2024, All dayTuesday, 13 February 2024, All day
Location
- European Medicines Agency, Amsterdam, the Netherlands
Event summary
This joint two-day 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 novel methodologies.
The event 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.
Video recording
Registration
In person participation is organised via EU associations and direct invitations to allow a broad range of stakeholders to participate. In person attendees will take part in face-to-face breakout sessions.
Virtual participation (in Webex) is possible upon registration by 12 January 2024:
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.