Newsletter January 2024

Dear Subscriber,

Welcome to the second edition of our newsletter! We share updates about the Real4Reg project, with a special focus on the insights gained from our first expert workshop held in November 2023. In this issue, we will also introduce you to one of our project partners, the INFARMED – National Authority of Medicines and Health Products, I.P., from Portugal. In upcoming editions, we will showcase our other project partners.

As the first year of Real4Reg is now concluded, we eagerly anticipate further development and growth in 2024. Wishing you a fantastic year ahead!

Real4Reg Workshop: Challenges in dealing with real-world data for Regulatory Purposes

The Real4Reg Consortium held its inaugural workshop on November 14, 2023, focusing on "Challenges in dealing with real-world data for Regulatory Purposes." The virtual event brought together participants from various backgrounds, including regulatory agencies, academia, industry, patient representatives, and payers’ representatives.

The keynote speaker Denise Umuhire from the European Medicines Agency (EMA) discussed the role of real-world data and evidence in medicines regulation, emphasising EMA’s pathways for generating real-world evidence. The presentation also delved into practical experiences outlined in the EMA report, “Real-World Evidence Framework to Support EU Regulatory Decision-Making” (available here), addressing challenges in the use of RWE and identifying opportunities for advancing regulatory decision-making.

The workshop also featured presentations from representatives of our MetReal Cluster sister projects ONCOVALUE and More-EUROPA and breakout sessions that facilitated discussions on data confidentiality, access, and harmonisation.

INFARMED, I.P., is a Portuguese agency, accountable to the Ministry of Health, that evaluates, authorises, regulates and controls human medicines as well as health products, namely medical devices and cosmetics for the protection of Public Health.

Aims

The institute’s main goal is to ensure the quality, safety and efficacy of medicines and the quality, safety and performance of health products to avoid the risks of their use while ensuring adequate standards of public health and consumer protection.
Amongst Infarmed’s top activities, the regulation and supervision of medicinal and health products from research up to their use by healthcare professionals and patients is particularly important.

Infarmed addresses a lifecycle approach for both human medicines and medical devices and is the body responsible for assessing evidence for the comparative effectiveness and cost-effectiveness of medicines and medical devices to be used by the Portuguese health system.

The institution monitors the utilisation of medicines in Portugal based on claims data, and more recently uses disease registries internally developed (for hepatitis C and Spinal Muscular Atrophy) or in collaboration with other entities (National Cancer Registry) to monitor and reassess pricing and reimbursement decisions.
Infarmed performs at national and European levels its competencies and responsibilities of National Competent Authority on medicines and health products and of Reference Laboratory on the Quality Control of Medicines within the scope of the Network of Official Medicines Control Laboratories (OMCL).

To fulfil its mission, Infarmed carries out Portugal's tasks within the framework of the European System of Medicines namely by ensuring the representation and participation in the various evaluation and supervision bodies and activities of the European Medicines Agency (EMA), of the European Commission and the European Network of Medicines and Health Products Competent Authorities.

INFARMED is also a member of the World Health Organization (WHO) Collaborating Centre for International Drug Monitoring through the Uppsala Monitoring Centre.

Role in Real4Reg

In Real4Reg, INFARMED contributes data from the Portuguese health system and coordinates the dissemination, communication, and exploitation of the project, ensuring that the results reach the stakeholders of EU member states.

News

Introducing Our Informative Brochure

Our project recently launched a brochure offering an overview of key facts, aims, use cases and work packages.

Consortium meeting

On December 12, the IV Real4Reg Consortium Meeting brought together project partners for extensive discussions and exchanges. The afternoon session featured experts from the Real4Reg Advisory Board and, for the first time, representatives from sister projects in the MetReal Cluster. A highlight of the day was a talk by Dr. Daniel Morales from the European Medicines Agency on "Federated Networks for Pharmacoepidemiology Studies.

Real4Reg Partners' Participation in Key Events

Throughout the past year, the Real4Reg partners have actively engaged with the scientific community, participating in various international events to exchange insights and showcase our project.

Upcoming Events

21-23 February 2024, Amsterdam, Netherlands: TRICALS Masterclass 2024. TRICALS is the largest European research initiative to find a cure for ALS. The TRICALS Masterclass is an informal meeting to discuss innovations in clinical trials where established researchers, industry, patient (representatives) and regulatory organisations can participate.
read more

12-14 March 2024, Brussels, Belgium: DIA Europe 2024. DIA Europe 2024 will focus on sustainability, innovation and collaboration – three key pillars for shaping the future of healthcare. DIA Europe 2024 will be the prime opportunity to discuss how collaboration and innovation can support sustainability in healthcare and each stakeholder’s role in making it happen.
read more

20-21 March 2024, Hannover, Germany: AGENS Methods Workshop (Arbeitsgruppe Erhebung und Nutzung von Sekundärdaten/ German Working Group on collection and utilisation of secondary data).
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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