Multiple sclerosis workshop - Registries initiative

• Date:
  Friday, 7 July 2017, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

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.

Documents

Agenda – Registries initiative – Multiple sclerosis workshop

Reference Number: EMA/648996/2017

Presentation – Multiple sclerosis workshop - Pre-work package

Table of recommendations - Multiple sclerosis workshop

Reference Number: EMA/651859/2017

Details of the German and Italian national registries

Reference Number: EMA/674603/2017

Report on multiple sclerosis registries

Reference Number: EMA/548474/2017