The description of the submission process was published on the DARWIN EU® website, including a review of the role data partners play and the ways they may benefit from being a part of the network.
At the time of the launch, and coinciding with the start of its second year, DARWIN EU® had a network of ten data partners and successfully published three studies on the EU PAS register. The ambition is to consistently onboard more data partners every year, who in turn will be asked to participate in the significant volume of studies that are expected throughout the initiative’s lifespan.
SYNAPSE, as lead of the CC’s Management Pillar, has overseen the development and execution of the Open Call, and will continue to manage and review submissions from interested custodians. Specifically, by building on its experience and success of the EHDEN Calls, and in collaboration with EMA, SYNAPSE has established a submission and review process that is accessible to all, promotes the benefits of participating in DARWIN EU®, and facilitates the evaluation of all submissions while also ensuring they are kept to a high standard of quality.
The Open Call will be an ongoing activity within DARWIN EU® and for SYNAPSE, with reviews of all submissions taking place at regular intervals within the project year.
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®).