Newsletter July 2025

Dear Subscriber,

Welcome to the latest edition of the Real4Reg newsletter!

In this issue, we highlight our partner Aarhus University and present Work Package 1 – Use Cases in Pre-Authorisation & Evaluation.

You’ll also find a news article about our recent hybrid Consortium Meeting in Lisbon, discover the new Publications section on our website, and explore upcoming events in the field.

Real4Reg is using real-world data to improve research on breast cancer and ALS

Learn how Real4Reg is supporting health research through Work Package 1 (WP1), focusing on breast cancer and amyotrophic lateral sclerosis (ALS). By using health data from several European countries and applying artificial intelligence, the project aims to enhance the reliability and effectiveness of real-word data analysis in regulatory and health technology decisions.

WP1 uses a common data model to unify diverse datasets and applies machine learning to better understand these diseases and support earlier treatment access. Led by Aarhus University and in collaboration with partners across Europe, this work supports improved patient care and decision-making.

Partner presentation: Aarhus University

Aarhus University (AU) is a leading public research university located in Aarhus, Denmark. It offers a wide range of academic programs and is renowned for its research in areas such as climate, health, and technology. Department of Clinical Epidemiology (DCE) at the Department of Clinical Medicine is a large full-service academic department carrying out research, teaching and supervision. The department is affiliated both with the Aarhus University and Aarhus University Hospital.

Aims

DCE, founded in 2000, is a highly specialised research department working with clinical epidemiology at international level. Its mission is to improve clinical care through high-quality clinical epidemiological research, education, and translation of knowledge into clinical practice. DCE seeks to fulfil its mission by four means: 

• Free and independent research at an internationally high level
• Methods development
• A graduate programme
• Consulting clinical departments and public authorities regarding clinical epidemiology

DCE’s research is focused on prevention, diagnostics, treatment, and prognosis. DCE covers 16 research areas, most of them related to diseases. All research areas address important scientific and public health issues, not only relevant to Denmark, but to many countries around the world. DCE also work within related areas such as biostatistics, evidence-based medicine, e-health, and quality assessments. In addition, DCE offers consultancy services to health authorities as well as to the pharmaceutical and biotech industries.

DCE builds on a long tradition of research and teaching within epidemiology at Aarhus University. It strives to maintain an international and stimulating work environment with highly qualified employees with good social skills.

Role in Real4Reg

In Real4Reg, DCE AU contributes its expertise in the analysis of data from Danish population-based health and administrative registries, and with clinical epidemiology expertise in the successful execution of the use cases of the project. Since 1 September 2024, DCE AU has been leading Work Package 1 (WP1), whose overall objective is to prepare a good practice example for the analysis of real-world data (RWD) in the pre-authorisation stage and to improve methods for assessing external validity in observational data. Primarily, WP1 will investigate the value of RWD from European national registers and statutory health insurance data (claims data) in generating high-quality, accessible, population-based information on breast cancer and ALS (diagnosis, treatment, outcome).

DCE AU in media

News

Real4Reg Consortium Holds X Consortium Meeting in Lisbon

The Real4Reg European consortium held its annual in-person meeting on May 21–22, 2025, in Lisbon, in a hybrid format. The event brought together international experts, clinical specialists, and representatives from partner institutions to discuss recent developments and preliminary results of the project. 

Publications Section on Our Website

We’ve added a section featuring articles published as part of the project to our website.

Upcoming Events

22-26 August 2025, Washington DC, USA
41st Annual Meeting International Society for Pharmacoepidemiology
Real4Reg was selected to present Real4Reg was selected to present three posters:

• ‘EU-Wide Survey on Key Stakeholders’ Knowledge, Opinions and Interests on Real-World Evidence in the Regulatory Process‘,
• ‘Feasibility of Supplementing Single-Arm Trials with External Control Arms – Evaluation of German Real-World Data,
• Oral antibiotic use with focus on fluoroquinolones during 2010-2021 in four European countries: Finnish results of the HORIZON-EU project “Real4Reg”.

Go to event


23-25 September – Münster, Germany
Annual conference of DGEpi "Changing the face of epidemiology"

Go to event

For more information on additional events in the realms of real-world data, artificial intelligence, and health, please consult our Events page.

Follow Real4Reg on Social Media

RealReg is a project funded by the European Union under the Horizon Europe programme –Project No. 101095353. The consortium of ten European institutions aims to promote the use of real-world data to support regulatory decisions about medicines. For media inquiries, please contact: real4reg@infarmed.pt

Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or the European Commission. Neither the European Union nor the granting authority can be held responsible for them.

Imprint

Federal Institute for Drugs and Medical Devices (BfArM)
Represented by the President
Prof. Dr Karl Broich

Headquarters Bonn:
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn
Germany

Headquarters Cologne:
Waisenhausgasse 36-38a
50676 Köln

Phone: +49 (0)228 99 307-0
Fax: +49 (0)228 99 307-5207
E-mail: poststelle@bfarm.de

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