Newsletter December 2024

Dear Subscriber,

Welcome to the latest edition of the Real4Reg newsletter. In this edition, we bring you highlights from the Real4Reg 2024 workshops, where professionals and patients shared their perspectives on the evolving role of real-world data in healthcare. We are also pleased to introduce one of our partners, the Data Analytics Centre of the Danish Medicine Agency, whose collaboration is pivotal to the project. As we approach the end of the second year of Real4Reg, we look forward to continuing to share updates and developments in the coming months.

Highlights from the Real4Reg 2024 Workshops

Workshop 1: Insights into Stakeholder Needs

This workshop targeted professionals from various fields, including regulatory agencies, health technology assessment bodies, academia, industry, payers, healthcare institutions, and patient associations, among others.

The workshop included a presentation by Luca Giraldi (European Medicines Agency, EMA) on the EMA's vision for RWE and the Big Data Training Curriculum, findings from the Real4Reg survey on RWD, AI/ML, and training needs, and a multistakeholder panel discussion.

Workshop 2: Demystifying Real-World Data for Patients

This session aimed to simplify the concepts of RWD and RWE, providing patients and the general public with a clearer understanding of the field while addressing common questions related to data privacy and ethics.

The workshop included a presentation by Nicolas Thurin (University of Bordeaux) on RWD and its uses, an overview of the Real4Reg project, a session by Chloé Antoine (University of Namur) on ethical and privacy considerations in RWD, and a roundtable discussion addressing these issues from patient perspectives.

You can find a summary of the discussions, key takeaways, recordings, and presentations on our website.

Partner presentation: Data Analytics Centre (DAC), Danish Medicine Agency

The Danish Medicines Agency (DKMA) (Lægemiddelstyrelsen) is an agency under the Ministry of the Interior and Health (https://www.ism.dk/english). The purpose of the agency is to ensure that medicinal products used in Denmark are of satisfactory quality, are safe to use and that they have the desired effect. It supervises companies manufacturing and distributing medicinal products. This is done through administering the Danish legislation on medicinal products, reimbursement, pharmacies, medical devices and euphoriants. The agency performs most of the tasks in close cooperation with colleagues from regulatory authorities and organisations in other EU countries.

Data Analytics Centre

The Data Analytics Centre (DAC) of the Danish Medicines Agency is located in Copenhagen, Denmark. DAC leverages to utilise big data to generate insights and develop methods & tools to support the use of safer and more effective medicines to benefit patients, pharma, payers, providers, policymakers and DKMA/European Medicines Agency (EMA).

DAC collaborates with a diverse range of partners both domestically and internationally. A strategic partnership with the Danish National Genome Centre (NGC) forms the backbone of DAC, providing access to NGC’s High-Performance Computing System. DAC also works closely with the Danish scientific community and is establishing connections with leading international research institutions. DAC has established collaborations with other national competent authorities within the EU, aiming to build a robust European network of regulators in health data analytics and regulatory science.

DAC utilises a wide range of data sources. Through the Danish Health Data Authority, the National Clinical Registries, and others, DAC has access to some of the most sophisticated and comprehensive patient-level health data in the world. Analyses are conducted on the Danish National Genome Centre’s supercomputer, which adheres to the highest standards of data and IT security.

Role in Real4Reg

DKMA/DAC led Work Package 1 (January 1, 2023 to August 31, 2024) and was responsible for the coordination and management of use cases 1 and 2. DAC obtains protocol-based access to data from the Danish population registries, which are owned by Danish Data Health Authority. Additionally, DAC is involved in data analyses for all use cases. In the period September 1, 2024 to December 31, 2026 DAC will continue supporting Real4Reg in close collaboration with the new Work Package 1 leaders at Aarhus University.

DKMA in media

News

Real4Reg Shares Insights on RWD External Control Arms at GAA Meeting

Real4Reg members participated in the 31st Annual Meeting of the German Drug Utilisation Research Group (GAA), held from 21-22 November 2024 at the Federal Institute for Drugs and Medical Devices, BfArM, in Bonn.

Real4Reg at INFARMED’s Annual Conference

INFARMED organised its 2024 Annual Conference on 20 November in Lisbon, under the theme "Innovative Future of Medicines and Health Technologies: Regulatory Strategies, Digitalisation, and Integration". The event brought together national and international experts who discussed the emerging challenges and opportunities in the health sector.

The Real4Reg project was frequently mentioned throughout the day as a prime example of an innovative initiative in the field.

Upcoming Events

19-21 February 2025, Amsterdam, The Netherlands - TRICALS Masterclass 2025
Read more

18-20 March 2025, Basel, Switzerland - DIA Europe 2025
Read more

19-21 March 2025, Singapore - AI in Health Summit
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

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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