GREG – “Testing, improving, and co-creating Guidance and Tools for Real World Evidence Generation and Use for Decision-Making in Europe”.

This is achieved through a close collaboration with 29 public and industry partners from 15 countries, over a period of 5 years (May 2025 – May 2030). The project is divided in 9 work packages.

The overarching aim of the GREG project is to generate, pilot-test, and disseminate evidence-based guidance and tools for the use of Real-World Evidence (RWE) to inform the development and evaluation of medicines, medical devices, and drug-device combinations to support and guide regulatory and Health Technology Assessment (HTA) decision-making. Learnings from existing RWE initiatives in Europe will be leveraged to meet this aim.

Our outputs will include evidence-based guidance documents and tools, with input and/or endorsement from key decision-making bodies, training for all involved stakeholders on the use of our guidance and tools, online resources, software tools, practical documents, and structured templates. Together, these will lead to more robust and consistent RWE submissions to European HTA and regulators, consistent assessment by regulators and HTA bodies, aiming at faster access to better medicines, medical devices, and drug-device combinations for European patients and citizens.