In Europe, numerous initiatives and networks have created multiple guidelines and recommendations for the use of RWE. However, many challenges persist in the implementation of these guidelines and recommendations, limiting their uptake, use and acceptance by key stakeholders. Additional challenges remain due to the variability in the use and adoption of RWE for the evaluation of health technologies by regulators and HTA, and for the development and assessment of medicines and medical devices.

The GREG project was initiated to take on these challenges. Guidance and tools generated during the project will be practical and co-created with and for its users. This will not only include reports and publications, but also online resources and software tools designed to address adoption barriers among European regulators, HTA bodies, healthcare professionals, and industry sponsors.

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A Collaborative and Multidisciplinary Effort

The GREG project is uniquely designed to change the landscape of RWE by bringing together many different entities including academia, regulators, HTA agencies, non-governmental organizations (NGOs), project management experts and industry leaders from the medicines, medical device and drug-device sectors. The consortium is led by 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). Bringing together twenty-nine (29) partner organizations from fifteen (15) countries, the GREG initiative will continue for five years with a budget of €26.2 million, of which €13.2 million is funded by IHI, and €13.0 million by industry.

SYNAPSE brings extensive project management expertise to the project and takes the lead in project management and coordination of the GREG initiative. This includes day-to-day project management, supporting the project leader and coordinator, and managing partnerships as well as financial and administrative tasks. Furthermore, SYNAPSE is involved in the generation of communication tools and the project website, as well as the design of an exploitation and sustainability plan.

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"At SYNAPSE we are proud of leading the project management of the GREG initiative, and contributing to the communication and exploitation of results. The use of Real World Evidence will be improved by the generation and dissemination of guidance and tools in GREG, with the ultimate goal of faster access to better medicines for European patients." - Montse Camprubí (Senior Project Manager)

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Main Objectives

The main objective of the GREG project is to generate, pilot test, and disseminate evidence-based guidance and tools for the use of RWE. This will be used to inform the development and evaluation of medicines, medical devices and drug-device combinations supporting and guiding regulatory and HTA decision-making. The evidence-based guidance and tools will include input from key decision-making bodies and all involved stakeholders will be trained in the use of this output.

Future vision

The GREG initiative is a cutting-edge project focused on creating a sustainable framework that provides up-to-date guidance and tools. This project will galvanize the generation of more robust and consistent RWE submissions to European HTA and regulators and consistent assessment by regulators and HTA bodies. Altogether, this will result in faster access to better medicines, medical devices and drug-device combinations for European patients and citizens.

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For more information, check GREG website and follow the project on LinkedIn.

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