As coordinators of the GREG project, we are thrilled to share the first edition of the GREG Newsletter with you. These newsletters will be published bi-annually and provide regular updates including progress of the project, achievements and upcoming events. In addition, each issue will spotlight a key topic. We hope you enjoy reading this newsletter and look forward to sharing more information on the project’s progress and achievements in the years to come.
Daniel Prieto Alhambra, Project Coordinator, Erasmus University Medical Center: “As RWE needs increase, there is a clear need for alignment on the best methods, data, and tools for the generation and use of this evidence to inform the development and evaluation of medicines and devices. GREG will deploy a dedicated team of experts to review existing guidelines, fill the gaps in the literature, and generate and pilot-test evidence-based guidance and tools for better RWE generation in Europe.”
Emel Mashaki Ceyhan, Industry Lead, Novo Nordisk: “The field of Real-World Evidence has been gathering much deserved attention in recent years as RWE has the potential to generate valuable and high-quality evidence which could complement clinical trials and inform decision making in clinical development, regulatory review as well as health technology assessments. This potential has not been fully reached despite the recent significant efforts and advancements in this field. Therefore, we strongly believe and remain confident that the outcomes of the GREG project will transform the way RWE is utilized in decision making and enable its use and implementation with confidence by sponsors, to bring innovative treatments to patients faster.”
Our Project
The GREG project officially launched on the 1st of May 2025 to address persistent challenges in the generation, implementation, and acceptance of Real-World Evidence (RWE) for medicines, medical devices, and drug-device combinations in Europe. GREG is a public-private partnership supported by the Innovative Health Initiative Joint Undertaking (IHI JU), set to impact Real-World Evidence practices in Europe. The GREG initiative aims to create, test, and share practical, evidence-based guidance and tools to help generate and use RWE. By improving how RWE informs the development and evaluation of medicines, medical devices, and drug-device combinations, we will support better decision-making for regulators and HTA bodies.
GREG Consortium
GREG brings together 29 partner organizations from 15 countries, uniquely positioning the project to drive advancements in European RWE practices. The consortium is led by the Erasmus University Medical Center (The Netherlands) as the Coordinator, Novo Nordisk (Denmark) as the Project Lead and Sanofi (France) as the co-lead and is supported by the University of Oxford (United Kingdom).
This project gathers 15 public entities, of which eight are top-tier academic institutions, two small- and medium-sized enterprises, two Health technology assessment bodies (HTA), two non-profit organizations, one Healthcare professional organization, and one multistakeholder forum; and 14 industry leaders representing the (bio) pharmaceutical and the medical devices fields.
The first 6 months of GREG
Following the start of GREG, the Kick-off meeting in Rotterdam (The Netherlands) provided an excellent opportunity for productive discussions gathering the full consortium together. The Kick-off meeting focused on aligning expectations, defining working methods and laying the foundation of the WPs goals. A key takeaway from the meeting was the importance of strong collaboration and clear communication across all work packages to ensure alignment in the work generated from all workstreams.
Since the launch of GREG in May, the consortium has made significant progress across several key topics.
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Members were recruited for four external advisory boards: the Scientific Advisory Board, Ethics Advisory Board, HTA Expert Forum and Regulatory Stakeholder Forum.
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A first version of the GREG RWD Catalogue was developed – an interactive dashboard of datasets.
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Significant progress was made on the GREG Chatbot to recommend users, supported by a large knowledge base (currently under development).
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Establishment of Use Case selection processes to assess relevance and feasibility of submitted Use Cases.
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Shaping of the Living Library of RWE Use Cases to identify and compile learnings.
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Contribution to IHI’s strategy and plans for interaction between projects with regulation-related deliverables.
The GREG Consortium also participated in the European Society of Cardiology (ESC) Congress 2025 in Madrid, one of the leading global events in cardiovascular medicine. During one of the official ESC TV Connect sessions, GREG hosted a dedicated discussion on the increasing influence of real-world data and registry-based evidence on regulatory frameworks, particularly under the EU Medical Device Regulation. Featuring contributions from GREG partners Dr. Lars Wallentin (Uppsala Clinical Research Centre) and Prof. Tom Melvin (University of Galway), the session highlighted the importance of high-quality, standardised real-world evidence and federated data analysis to support regulatory decision-making while preserving data privacy. The discussion showcased GREG’s vision for strengthening collaboration between clinicians, regulators, and innovators to enable smarter, faster, and more patient-centred cardiovascular care.
Spotlight: Use Cases
Over the past months, a major area of focus has been on establishing the foundations for the Use Cases relevance and feasibility processes. Last month, the steering committee convened in Paris for a 2-day Use Case Workshop, where we discussed and tested these processes using the first wave of Use Cases submissions. This was a great opportunity to make significant progress in the Use Case processes and ensure alignment between Work Packages.
A key aspect of the use cases processes is the selection of analytical use cases. In WP3, Use Case selection process was designed, undertaking prioritisation of potential analytical projects submitted by consortium partners. The submitted use cases are judged according to their relevance to best support the development of practical RWE guidance, as well as feasibility. For example, relevance considers elements such as potential to explore important or innovative methods, potential generalisability of learnings, whether a topic of public health interest is addressed, and whether it covers a range of important areas e.g. treatments, drug device combinations, rare diseases. The evaluation and ranking of the first-round Use Case submissions have been completed by the consortium members.
To support the development of evidence-based practical guidance, members were recruited for two fora serving as external advisory boards in GREG, namely the Stakeholder Regulatory Forum and the HTA Expert Forum. The Stakeholder Regulatory Forum and HTA Expert Forum will support generation of harmonised guidance for use of RWE across regulatory settings and HTA settings, respectively, offering expertise in scientific and technical evaluation. The Fora members are also invited to contribute to the Living Library of Use Cases, by submitting previous important case studies, including both successful and unsuccessful applications of RWE. The living library will also include “deep dives” focusing on specific topics, covering the use of RWE in the entire product lifecycle.
If you’d like to stay up to date with the GREG project, sign up to our biannual Newsletter, follow us on YouTube, and LinkedIn. Feel free to reach out to us at info@ihi-greg.eu if you have any questions!
