Newsletter September 2023

Dear Subscriber,

we are pleased to welcome you to the inaugural edition of the Real4Reg newsletter! In this edition, we introduce you to the Real4Reg project - a groundbreaking initiative that stands for the development, optimisation, and implementation of artificial intelligence methods for real-world data analyses in regulatory decision-making and health technology assessment along the product lifecycle. In the following editions, we will explore various topics within the project's scope. Stay tuned with us.

Introducing Real4Reg - Unlocking Real-World Data with AI

In an era driven by data and innovation, the Real4Reg project emerges as a source of transformative potential. To leverage the potential of real-world data (routinely collected data relating to patient health status or the delivery of health care from a variety of sources other than traditional clinical trials), the project will use artificial intelligence methods to develop and implement analyses throughout the medicines' life cycle. This initiative is positioned to make a difference in how regulatory decisions are made and health technologies are assessed.

In the pre-authorisation and evaluation phase of medicines, the project will focus on investigating the utility of real-world data (RWD) in providing population-based information and addressing questions that are not conventionally addressed through clinical trials. This exploration will be carried out in the context of two distinct disease domains: breast cancer and amyotrophic lateral sclerosis (ALS). Additionally, in the post-authorisation phase, the analysis will encompass the safety assessment of drugs within the broad-spectrum antibiotic class fluoroquinolones, as well as the repurposing of existing drugs for novel therapeutic applications, exemplified by SGLT-2 inhibitors.

For a more in-depth understanding of the project's structure and methodologies, use cases, and innovative approaches, we encourage you to explore our website. Alongside information for experts in the field, a section aimed at the public, named “Information for Patients” is also available.

A Collaborative Network of Excellence

At the heart of Real4Reg lies a consortium of ten distinguished institutions from six European countries. This partnership brings together the expertise and perspectives of regulatory and health technology assessment agencies, academic institutions, and patient associations.

The advisory board is composed of prominent experts from various stakeholders involved in real-world evidence in the regulatory and health technology assessment (HTA) context. These stakeholders include regulatory agencies, European patient organisations, HTA, clinical experts, as well as representatives from the industry and payers. The board's role is to offer in-depth analysis and guidance for the project.

Real4Reg will also foster synergies with other health-related EU programs and European infrastructures (EHDS, DARWIN EU, MetReal Cluster).

Please visit our website to learn more about the consortium partners, the composition of our advisory board, and related projects.

News

Real4Reg Partners Convene for Productive Virtual Meeting

On 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 goals.

Real4Reg study received an ENCePP Seal

The Real4Reg study was registered in the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) database, a network coordinated by the European Medicines Agency (EMA). Following its adherence to the ENCePP Code of Conduct and internationally recognized guidelines, the Real4Reg study has been awarded an ENCePP Seal.

Upcoming Events

26 -28 September 2023, Würzburg/Germany: 18th annual meeting of the German Society of Epidemiology (Deutsche Gesellschaft für Epidemiologie, DGEpi). The Real4Reg project was selected for an oral presentation at the DGEpi meeting. This year’s motto is “Epidemiology in Transition – Innovations and Challenges”.
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15-16 November 2023, Virtual: DIA Innovating Clinical Trials in Europe Conference. The Real4Reg project will be presented within the session “Real-World Evidence in Regulatory and HTA Decision Making: Report on MetReal Cluster covering 5 European Horizon Europe Projects”.
read more

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

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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