Real4Reg – Unlocking Real-World Data with AI
Real4Reg is a consortium of nine 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 is taking 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 is using data sources from four European countries (Denmark, Finland, Germany, and Portugal) and is developing 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
Description of Study population: breast cancer, ALS
Real4Reg is assessing the value of real-world data from national healthcare registers and claims data in generating high-quality, accessible, population-based information on breast cancer and amyotrophic lateral sclerosis (considering the diagnosis, treatment, and outcomes).
Historical controls and synthetic data: breast cancer, ALS
Real4Reg is demonstrating how the real-world data can contribute to questions that are not typically answered by clinical trials, due to ethical or practical issues. These questions need to be answered for regulatory evaluation and health technology assessment, in the improvement of external validity and statistical power and precision.
Safety: Fluoroquinolones
The overall objective of this use case is to prepare a good practice example for safety analyses of real-world data for the post-authorisation stage and to improve methods for risk estimation in observational data. Real4Reg is also evaluating the impact of regulatory warnings on the use of broad-spectrum antibiotics.
Effectiveness and drug repurposing: SGLT2 Inhibitors
Real4Reg is preparing a good practice example for drug effectiveness and drug repurposing analyses of real-world data for the drug post-authorisation stage. The case of Sodium-glucose Cotransporter-2 (SGLT2) inhibitors is being analysed. These antidiabetic medicines have shown beneficial effects on cardiovascular outcomes in recent years.
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Latest News
Real4Reg XIV Consortium Meeting in Bonn, Germany – Recent Developments and Upcoming Steps
Read more: Real4Reg XIV Consortium Meeting in Bonn, Germany – Recent Developments and Upcoming StepsOn May 19-20 2026, BfArM hosted Real4Reg’s annual in-person meeting in Bonn (Germany). The event was held in a hybrid format which allowed exchanges regarding Real4Reg’s latest developments between the members of each institution belonging to the consortium, Advisory Board and international specialists on the topics studied in the project. The first day started with…
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Latest News
Highlights from the 2026 Patients Workshop “Real-World Data and Patients: Breaking the Ice”
Read more: Highlights from the 2026 Patients Workshop “Real-World Data and Patients: Breaking the Ice”On April 13, Real4Reg hosted its second Patients Workshop entitled “Real-World Data and Patients: Breaking the Ice”. This event had an audience of over 100 people and even though patients and patients’ organisation representatives were a significant portion of the attendees, the workshop also showed to be interesting for pharmacists, nurses, regulatory affairs and pharmacovigilance…
Upcoming Events
- 3-5 June 2026 – Tromsø, Norway – NordicEpi & NorPEN Conference 2026
- 24-26 June 2026 – Madrid, Spain – ENCALS Meeting 2026
- 29-30 June 2026 – Utrecht, Netherlands – GetReal Institute Annual Conference “Translating Real-World Data Into Decision-Ready Evidence: Bringing Data, Methods, and Decisions Context Together”
- 29 August – 2 September 2026 – Milan, Italy – 42nd Annual Meeting ISPE
- 22-24 September 2026 – Ulm, Germany – 21st Annual Conference of the German Society for Epidemiology (DGEpi) “Epidemiology for the challenges of today and tomorrow”
Who we are
Our consortium assembles nine 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.