16/10/2017: EMA communication: Publication of new outcome reports on cystic fibrosis and multiple sclerosis patient registries
The European Medicines Agency (EMA) has an initiative to make better use of existing patient registries and to facilitate the establishment of high-quality new registries, as needed. The initiative explores ways of expanding the use of patient registries and introducing and supporting a more systematic and standardised approach for their contribution to the benefit-risk evaluation of medicines within the European Economic Area.
The outcome reports of two workshops (cystic fibrosis and multiple sclerosis) are now available. The objectives for each workshop were to agree on implementable recommendations on the core data elements to be collected in registries, protocols, consents, governance and registry interoperability and on the actions needed from the stakeholder groups to advance registry use.