Meeting with EMA


As the EHR4CR project prepares for deployment, engagement with key stakeholders has been increasing. The project was pleased to accept the invitation from the EMA's GCP Inspectors Working Group to present at their recent meeting in September. Members of the Communication Task Force presented and discussed key aspects of the project:

  • the opportunities that are being created to improve the efficiency of clinical research and healthcare operations through access to de-identified health records
  • the technical solutions that are being developed
  • the business model and approach to addressing data security, privacy and governance challenges
  • the deployment plans
  • Engagement with European regulators is critical to ensuring that the approach the project has adopted is robust and adequately addresses today's needs and concerns. During the meeting, a number of concerns raised by the EU GCP IWG were discussed with regard to the main challenges this project will have to address. Overall, the GCP inspectors welcomed the initiative and requested that the project keeps them updated on outcomes from the pilots.