
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
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Latest News
Successful Multi-Stakeholder Workshop on RWD in Regulatory and HTA Decision-Making
Read more: Successful Multi-Stakeholder Workshop on RWD in Regulatory and HTA Decision-MakingOn Thursday, 6 February 2025, the Multi-Stakeholder Workshop on Real-World Data (RWD) in regulatory and Health Technology Assessment (HTA) decision-making took place at BfArM, in Bonn, Germany.
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Latest News
Real4Reg Partners’ Participation in Key Events: a Brief Recap of 2024
Read more: Real4Reg Partners’ Participation in Key Events: a Brief Recap of 2024As 2025 begins, it’s a good moment to look back at some of the key events that marked the Real4Reg journey in 2024. From important discussions to collaborative initiatives, the past year was full of activities and achievements.
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.