Newsletter March 2026

Dear Subscriber,

Welcome to the eleventh edition of the Real4Reg’s newsletter!
In this issue, we highlight our upcoming Patients Workshop “Real-World Data and Patients: Breaking the Ice” and present the MetReal cluster projects.

Furthermore, you’ll be able to find news about the Experts Workshop that took place in January, a new scientific publication, a new website section and an article with a recap of Real4Reg’s participation in dissemination events in 2025. At the end, you will be able to stay up to date on upcoming events.

Real4Reg Patients Workshop 2026 – 13th April: “Real-World Data and Patients: Breaking the Ice”

On April 13th, at 15:00-16:30 CET, Real4Reg will present an online Workshop, under the theme “Real-World Data and Patients: Breaking the Ice”.

This event, dedicated to patients and general public, will focus on how patients view real-world data (RWD), regarding its importance, future impact and willingness to share it with researchers in healthcare context. An explanation on how RWD can be used in multiple healthcare areas, namely in academic research, public health research and monitoring, regulatory and other government agencies and private sector research, will be provided by Martin Russek (BfArM).

In addition, the platform PatientsLikeMe, where patients can share their health-related data and keep in touch with people under the same circumstances, will be presented by Erlyn Macarayan. Some of the explored topics will be the different sections within the website that patients can use and the patient’s reported benefits of being part of an initiative like this.

MetReal Cluster

The MetReal cluster is a group of research projects, funded by the 2022 EU Horizon Europe program, with durations that range from three to five years. The projects are: INSAFEDARE, More-EUROPA, ONCOVALUE, REALM, Real4Reg, and REDDIE. The underlying common topic is “New methods for the effective use of RWD and/or synthetic data in regulatory decision-making and/or in health technology assessment (HTA)”.

Besides Real4Reg, here are the aims of each project:

INSAFEDARE – Innovative Applications of Assessment and Assurance of Data and Synthetic Data for Regulatory Decision Support

INSAFEDARE main goal is to support medical device regulation, making it more reliable and economically efficient, through the elaboration of a toolkit. The validation and assurance procedures will incorporate RWD and synthetic data. 

More-EUROPA – More Effectively Using Registries to Support Patient-Centered Regulatory and HTA Decision-Making

The main goal of More-EUROPA is to define standards and develop methods to successfully incorporate RWD in drug development, registration and assessment in Europe, making this process more efficient. The consortium aims to provide supportive information to traditional clinical trials and deliver real-world evidence (RWE) that can help regulatory agencies and HTA bodies assessment across the drug lifecycle.

ONCOVALUE – Implementing Value-Based Oncology Care at European Cancer Hospitals

ONCOVALUE seeks to demonstrate how European cancer centres can use RWD to generate RWE, which can be helpful to relate the effectiveness of new cancer therapies with their economic burden. The consortium’s target stakeholders - healthcare providers and regulatory bodies - will receive tools and training to implement this methodology.

REALM – Real-World Data Enabled Assessment for Health Regulatory Decision-Making

REALM focuses on creating a standardised platform to develop, assess and certify medical software, through a joint and transparent approach. It will include different functionalities, for example regulatory and post-authorisation surveillance tools, data resources, and a living lab for testing.

REDDIE – Real-World Evidence for Decisions in Diabetes

REDDIE’s main goal is to improve diabetes prevention and treatment through the inclusion of RWD to supplement traditional clinical trials and evaluate new technologies. To accomplish that, standards, techniques, and methodologies that permit the incorporation of RWD will be developed, allowing a better assessment of safety, efficacy, and cost-effectiveness in this area. 

News

Experts Workshop “Real4Reg Use Case 1: Lessons Learned on Exploring Real World Data”

On 27 January 2026, Real4Reg hosted an online Experts Workshop “Real4Reg Use Case 1: Lessons Learned on Exploring Real World Data”, with an audience of over 200 people. The invited speakers were Vera Ehrenstein (Aarhus University) and Mohamed Aborageh (Fraunhofer SCAI) and the topics addressed were the Use Case 1 – “Description of Study Population: Breast Cancer and ALS” results and the challenges in implementing the Observational Medical Outcomes Partnership (OMOP) common data model. Afterwards, a multistakeholder roundtable discussion took place, with Daniel Morales (EMA), Lucía Ortiz (Plataforma de Organizaciones de Pacientes), Piia Rannanheimo (Fimea), and Ruben van Eijk (University Medical Center Utrecht). If you missed the event, the recording and the presentation are available on our website. 

Real4Reg New Scientific Publication

On 20 December 2025, Real4Reg published its’ latest scientific article “Key Stakeholders’ Knowledge, Opinions, and Interests on Real-World Evidence in the Regulatory Process – Results of an EU-Wide Survey”, in Clinical and Translational Science journal. This publication addresses the different perspectives of multiple stakeholders, specifically regulatory authorities, HTA bodies, pharmaceutical industry, academia, payers, patients, and physicians, on RWD and implementation of artificial intelligence (AI) in HTA and regulatory decision-making. The main findings include the consensual opinion among different stakeholders regarding the importance of RWD in the future and some barriers that might prevent its’ utilisation, such as data quality, access, and standardisation.  

Summary Statistics – New Section

A new section has been added to the Real4Reg’s website called Summary Statistics. Here you are able to find key characteristics of the conditions and medications studied in Real4Reg (breast cancer, amyotrophic lateral sclerosis (ALS), antibiotic consumption and diabetes medicines), for example demographic characteristics and overall survival of breast cancer and ALS patients, number of antibiotics prescriptions or mean age at prescription for SGLT-2 inhibitors.  

Real4Reg Partners’ Participation in Key Events: a Brief Recap of 2025

Since the beginning of the project, 2025 has been the year with most participations in dissemination events, such as meetings, conferences, workshops, and congresses. This article summarises Real4Reg’s journey throughout the year, including oral communications, poster presentations or roundtable discussions in events like the 5th Nordic RWE and AI Conference, the International Society for Pharmacoepidemiolgy (ISPE) Annual Conference 2025, and the GetReal Conference 2025. These events are crucial to spread Real4Reg’s mission, goals and obtained results.

Upcoming Events

📅 8 April 2026, Online

RWE4Decisions Webinar: Improving Rare Disease Data Availability and Quality for HTA/Payers

Go to event

📅 14 April 2026, Brussels (Belgium) 

REALM Academy Workshop “From Data Federation to Medical AI Model Evaluation”

Go to registration 

📅 29 April 2026, online

More-EUROPA Webinar “Using Patient Registries to Support Regulatory Decision-Making: Exploring the Role of Patient Advocates – Insights From More-EUROPA”

Go to registration 

📅 17-20 May 2026, Philadelphia, USA

ISPOR 2026

Go to event page 

📅 25-28 May 2026, Genoa, Italy

Medical Informatics Europe (MIE) 2026 – “Opening the Personal Gate Between Technology and Health Care”.
INSAFEDARE Workshop “Assurance-Driven Certification of Medical Devices Using Synthetic Datasets: Demonstrating INSAFEDARE Tools”

Go to event page

📅 3-5 June 2026, Tromsø, Norway 

NordicEpi & NorPEN Conference 2026

Go to event

📅 19 June 2026, Brussels, Belgium

REALM Academy training – How to realize safe and effective AI in clinical practice

This one-day REALM Academy training brings together key stakeholders to explore how to develop, evaluate, and implement safe and effective AI in clinical practice.
Participants will gain insights into REALM methodologies and tools for artificial intelligence evaluation, including performance metrics, data quality, model validation, and regulatory considerations, as well as emerging approaches such as synthetic data and automated monitoring.

Location: Herman Teirlinck – Transitielab (Brussels, Belgium);
Participants: REALM stakeholders – limited to 30 attendees

Go to event page and registration

For more information on additional events in the realms of RWE, AI, 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

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