The initiative aims to provide robust and up-to-date evidence on the use, safety, and effectiveness of medicines for human use, including vaccines, by analysing real-world healthcare data from across the European Union. In 2024, the DARWIN EU® Coordination Centre is expected to deliver dozens of studies to the EMA and the EU medicines regulatory network.

The project required the prior mapping of healthcare data using the OMOP Common Data Model (OMOP CDM). This work resulted from a collaborative effort involving the CAC-EMHA Board of Directors, the Information Technology Departments of the Gaia and Espinho, Entre Douro e Vouga, and Aveiro Region Local Health Units, the Department of Electronics, Telecommunications and Informatics at the University of Aveiro, and MTG Research and Development Lab.