The GREG project officially commenced with a two-day Kick-Off Meeting held in Rotterdam on 14–15 May, where around 80 participants from academia, industry, regulatory bodies, and patient organisations took part. Supported by the Innovative Health Initiative (IHI JU), GREG aims to co-create and deliver evidence-based guidance and tools to support the generation and use of RWE for regulatory and health technology assessment (HTA) decision-making across Europe and beyond.
A Collaborative Start
The meeting in Rotterdam served as a platform to align expectations, define working methods, and lay the foundation for a series of work packages (WPs) that will guide GREG over the coming years. Central to the project is an iterative approach, which cycles through evaluation, co-creation, pilot testing, consultation, and dissemination – ensuring robust and actionable outputs.
Initial discussions on the first day reinforced the importance of cross-work package coordination, clear communication channels, and a shared commitment to practical, stakeholder-driven outcomes. There was a strong focus on laying the groundwork for the early identification and evaluation of use cases, ensuring that future outputs reflect both regulatory and patient needs.
Key Outcomes and Next Steps
Over the following months, GREG will focus on:
- Scoping and aligning methodologies across WPs dedicated to HTA, regulatory processes, and medical devices.
- Launching stakeholder forums, including patient advisory and regulatory stakeholder groups.
- Developing initial use cases and protocols to pilot guidance tools.
- Mapping available data and assessing feasibility through real-world data partners using federated approaches.
On the second day the GREG Consortium dedicated time to breakout sessions to have open discussions on how to assess the relevance and feasibility of proposed use cases. These sessions underscored the need for transparent criteria, the value of patient engagement, and the importance of learning from both successful and unsuccessful RWE submissions.
Building a Patient-Cantered, Interoperable Framework
True to its commitment to a patient-centred approach, GREG will engage patient communities in shaping guidance outputs and ensuring relevance to those most affected by health decisions. Sustainability and impact are also top priorities—with dedicated efforts in training, communication, and long-term integration into European health systems.
Looking Ahead
Following the conclusion of the GREG Kick-Off Meeting, partners moved forward with clear takeaways and immediate action points, including the refinement of the use case submission template, preparation of feasibility standard operating procedures (SOPs), and strengthened communication structures across work packages. Stakeholders will reconvene with early deliverables and protocols, setting the stage for a transformative journey in how real-world data informs healthcare decisions.
For more information about the project, follow the progress of the GREG project on our website and LinkedIn page.
