EMA Workshop to Explore Which Registry Data are ‘Fit for Purpose.’
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The EMA is interested to receive cross-industry nominations for in-person attendance representing pharmaceutical companies holding marketing authorisations for medicinal products intended for at least two diseases covered by any of the registries: Cystic Fibrosis, diseases with CAR T-cell therapy, Multiple Sclerosis, Spinal Muscular Atrophy, Huntington’s disease, Niemann-Pick Disease and Hemophilia.
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:
- 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 (12 February, afternoon)
- 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 (13 February, all day)
EUCOPE reports it foresees two potential short presentations from Industry:
- Lessons learnt following qualification of registries and impact on medicines development (Day 1)
- A use case highlighting opportunities & challenges of registries for regulatory decision-making (Day 2)
In addition, representatives will be expected to actively take part in the 2-day dedicated breakout sessions.
Virtual participation (in Webex) is possible upon registration by 5 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.