Multiple sclerosis workshop - Registries initiative

The EMA's initiative for patient registries explores ways of expanding the use of patient registries in the benefit-risk evaluation of medicines within the European Economic Area. The participants of the workshop on Multiple sclerosis registries included representatives from the European MS Platform (EMSP) and its EUReMS group, the “Big MS Data” group, national MS registries, marketing authorisation holders, health technology assessment and reimbursement bodies, patients, national competent authorities, and the EMA. The workshop objectives 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 in supporting regulatory benefit-risk evaluations.