
Real4Reg – Unlocking Real-World Data with AI
Real4Reg is a consortium of ten European institutions which aims to promote the use of real-world data (national healthcare registers and claims data) to support the regulatory decisions about medicines. Real4Reg will take advantage of ground-breaking technologies such as artificial intelligence and machine learning.
The structure and approach of our project aim to facilitate the implementation of the effective use of real-world data in regulatory decision-making and health technology assessment.

Data & Methods
Real4Reg will use data sources from four European countries (Denmark, Finland, Germany, and Portugal) and will develop solutions to address the data analytical needs of regulatory agencies.
From a methodological point of view, the project is aligned with the decision-making process in regulatory agencies, which can be broadly broken down into the pre-authorisation, evaluation, and post-authorisation phases of the product lifecycle.
Use Cases
Latest News
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Real4Reg Partners Convene for Productive Virtual Meeting
Read more: Real4Reg Partners Convene for Productive Virtual MeetingOn September 11th, the Real4Reg project partners convened virtually for a meeting that addressed key aspects of the collaborative initiative. The meeting covered a range of topics, including progress reports from working groups and challenges in OMOP mapping and data access. Despite the virtual format, participants engaged actively, demonstrating their commitment to advancing their collective…
Latest Events
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Real4Reg Consortium Meeting in Copenhagen
Read more: Real4Reg Consortium Meeting in CopenhagenThe Real4Reg consortium had its first hybrid meeting in the Danish capital city. The gathering brought together all consortium partners and advisory board members for productive discussions and presentations on the progress of the work packages and was hosted by the Danish Medicines Agency (DKMA) in collaboration with the Consortium coordinator, the Federal Institute for…
Who we are
Our consortium assembles ten partners from six different European countries with experience in the field of RWD analyses, including experts from regulatory agencies and health technology assessment bodies, academia, and patient organisations.
A project for the Patients
Real4Reg integrates two patient organisations to incorporate the patients’ perspectives and expectations along its work.