Project
GREG – “Testing, improving, and co-creating Guidance and Tools for Real World Evidence Generation and Use for Decision-Making in Europe”, is a 60-month initiative that began in May 2025, funded by the Innovative Health Initiative Joint Undertaking (IHI JU).
The generation and use of Real-World Evidence (RWE) to inform the development and evaluation of medicines, medical devices and drug-device combinations have globally increased. However, many challenges persist in the implementation of multiple guidelines and recommendations to generate reliable RWE, limiting the uptake and acceptance of RWE by key actors, including patients, healthcare professionals (HCP), regulators, Health Technology Assessment (HTA) agencies, payers, and industry.
The GREG consortium, uniquely positioned to make an impact on European RWE practices, united to bring a longstanding expertise in the planning, generation, appraisal, RWE for the development and evaluation of medicines and medical devices.
In order to respond in an agile way to needs for guidance and tools throughout the project, an iterative approach will be followed to develop, test, and disseminate the GREG guidance and tools. Multiple cycles of a 7-step process will be completed for each combination of products (medicines, medical devices, drug-device combinations) in their different applications (development, regulation, HTA).
GREG’s 7-step cycle
GREG’s 7-step cycle
Use cases
A selection of Regulatory and Health Technology Assessment (HTA) use cases will be reviewed to map relevant topics, needs, and barriers, facilitating consistent learnings, and the development of the above-mentioned guidance and tools. A library of regulatory use cases for medicines, medical devices, and drug-device combinations will be developed, highlighting scenarios where Real-World Evidence (RWE) plays a crucial role in the regulatory process.
This effort will involve engagement with key ongoing and upcoming Real-World Evidence (RWE) initiatives focused on regulatory action, as well as collaboration with the EMA, NCA, Notified Bodies, and relevant industry stakeholders.
Work Packages
WP1
Real-world data guidance to generate evidence for decision- makingLead by IACS & Novo
Creation of practical real-world evidence (RWE) guidance by reviewing guidelines, learning from cases, and collaborating with key actors for effective implementation.
WP2
Real-world evidence for regulatory decision makingLead by Galway & Bayer
Assessment of real-world evidence (RWE) methods for medical devices, as well as the identification of the best regulatory approaches, and testing of the GREG tools in real-world cases.WP3
Real-world evidence for health technology assessmentLead by NICE & MDT
Refinement of real-world evidence (RWE) submission tools, assessment of barriers, and support of post-marketing and lifecycle evaluation of medicines and medical devices together with Health Technology Assessment (HTA) bodies and relevant actors.WP4
Real-world evidence for medicines development and evaluationLead by EMC & Sanofi
Design and execution of use cases to evaluate existing real-world evidence (RWE) generation methods and guidelines, as well as pilot-test the upcoming GREG evidence-based tools and guidance.WP5
Development and evaluation of medical devices and drug- device combinationsLead by UOXF & Edwards
Assess RWE methods for medical devices and drug-device combinations, identify the best approaches for regulatory and Health Technology Assessment (HTA) review, and pilot-test GREG guidance and tools in real-world cases.WP6
Real-world data and federated analyticsLead by EMC & Pfizer
Tools provision and federated data analysis to support studies in work packages 2, 3, 4, and 5.WP7
Patients and patient communities in real- world evidenceLead by EUPATI & Novo
Prioritization of patients and empowerment of European patient and citizen communities to understand the value of real-world evidence (RWE) and real-world data (RWD) in decision-making.WP8
Communication, training, and sustainabilityLead by ESC & Sanofi
Maximization of project’s impact through sharing project outcomes, developing sustainability strategies, fostering collaboration with related initiatives, and conducting training programs.WP9
Project coordination and managementLead by Synapse & Novo
Responsible for overall project coordination, providing scientific and technical oversight, and ensuring accurate and effective execution.
Facts and Figures
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 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).
IHI supports collaborative research projects and builds networks of industrial and academic experts in order to boost health research and innovation in Europe. This Joint Undertaking receives support from the European Union’s Horizon Europe research and innovation programme and COCIR, EFPIA, Europa Bío, MedTech Europe, and Vaccines Europe.
