Real4Reg – Unlocking Real-World Data with AI
Real4Reg is a consortium of ten European institutions which aims to promote the use of real-world data (national healthcare registers and claims data) to support the regulatory decisions about medicines. Real4Reg will take advantage of ground-breaking technologies such as artificial intelligence and machine learning.
The structure and approach of our project aim to facilitate the implementation of the effective use of real-world data in regulatory decision-making and health technology assessment.
Data & Methods
Real4Reg will use data sources from four European countries (Denmark, Finland, Germany, and Portugal) and will develop solutions to address the data analytical needs of regulatory agencies.
From a methodological point of view, the project is aligned with the decision-making process in regulatory agencies, which can be broadly broken down into the pre-authorisation, evaluation, and post-authorisation phases of the product lifecycle.
Use Cases
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Latest News
Real4Reg Shares Insights on RWD External Control Arms at GAA Meeting
Read more: Real4Reg Shares Insights on RWD External Control Arms at GAA MeetingReal4Reg 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.
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Latest News
Highlights from the Real4Reg 2024 Workshops
Read more: Highlights from the Real4Reg 2024 WorkshopsOn October 14, the Real4Reg 2024 workshops provided an engaging platform for discussing the perspectives and insights surrounding real-world data (RWD) and real-world evidence (RWE). These sessions focused on the views and expectations of both professionals and patients, offering valuable input on the evolving role of RWD in healthcare.
Who we are
Our consortium assembles ten partners from six different European countries with experience in the field of RWD analyses, including experts from regulatory agencies and health technology assessment bodies, academia, and patient organisations.
A project for the Patients
Real4Reg integrates two patient organisations to incorporate the patients’ perspectives and expectations along its work.