DARWIN EU Initiative — How OHDSI Will Assist In Delivering Real-World Evidence & Supporting Regulatory Decision-Making Across Europe

The European Medicines Agency (EMA) recently announced the Data Analysis and Real World Interrogation Network (DARWIN EU) initiative to support the ability to deliver real-world evidence from across Europe on diseases, populations and the uses and performance of medicines.

This will enable the EMA and national competent authorities in the European medicines regulatory network to use these data whenever needed throughout the lifecycle of a medicinal product.

DARWIN EU will support regulatory decision-making by:
• establishing and expanding a catalogue of observational data sources for use in medicines regulation
• providing a source of high-quality, validated real world data on the uses, safety and efficacy of medicines
• addressing specific questions by carrying out high-quality, non-interventional studies, including developing scientific protocols, interrogating relevant data sources and interpreting and reporting study results

Video Presentation

Peter Rijnbeek, Head of the Department of Medical Informatics at Erasmus Medical Center, led this presentation about the DARWIN EU mission and five-year plan, the role of the coordinating center, and how OHDSI tools and standards can and will impact this initiative.

The EMA announced that the Erasmus University Medical Center would serve as the coordination centre for this project. Erasmus’ role is 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). Peter Rijnbeek, a long-time OHDSI collaborator and 2019 recipient of the Titan Award for Community Leadership, is the Head of the Department of Medical Informatics at Erasmus MC and is leading this effort, along with Dani Prieto-Alhambra, another Titan Award recipient who recently joined the Erasmus faculty.

Rijnbeek provides this presentation, which includes:

• information about the DARWIN EU mission, vision and five-year plan
• the DARWIN EU process for conducting studies
• information about data sources used by DARWIN EU
• the role of the coordinating center, and how OHDSI tools, including the OMOP Common Data Model, data standards and best practices can and will impact this initiative
• plenty more (including a fun video showing just how to sign ALL the papers needed for this contract)

The OHDSI community is proud to collaborate with Erasmus MC on this initiative to give the European Medicines Agency 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. 

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