The Coordination Centre will develop and manage a network of real-world healthcare data sources across the EU standardised to the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM) and will conduct scientific studies requested by medicines regulators and, at a later stage, requested by other stakeholders.
Synapse will provide project management services, collaborating along with Erasmus MC and other subcontractors in the set up of the necessary infrastructure of the Coordination Centre, and establishing the required business services. DARWIN EU® will be able to leverage the extensive work done within the European Health Data and Evidence Network (EHDEN) project funded by the Innovative Medicines Initiative (IMI), and the Observational Health Data Sciences and Informatics (OHDSI) community.
The vision of DARWIN EU® is to give EMA and national competent authorities in EU Member States access to valid and trustworthy real-world evidence, for example on diseases, patient populations, and the use, safety and effectiveness of medicines, including vaccines, throughout the lifecycle of a medicinal product.
Source: Erasmus MC News Press Release
The European Medicines Agency (EMA) and the European Medicines Regulatory Network established a coordination centre to provide timely and reliable evidence on the use, safety and effectiveness of medicines for human use, including vaccines, from real world healthcare databases across the European Union (EU). This capability is called the Data Analysis and Real World Interrogation Network (DARWIN EU®).