Strengthening Collaboration in Real-World Evidence: MetReal Cluster Multistakeholder Meeting in Copenhagen
2–3 March 2026 | Danish Medicines Agency, Copenhagen
On 2–3 March 2026, the REDDIE project organised a Multistakeholder Meeting in Copenhagen, kindly hosted by the Danish Medicines Agency (DMA), and held in close collaboration with the MetReal Cluster. The two-day meeting brought together representatives from REALM, More-EUROPA, ONCOVALUE, Real4Reg, Insafedare & REDDIE, as well as regulators, HTA bodies, industry, and patient representatives to strengthen dialogue on real-world evidence (RWE) and its growing role in regulatory and HTA decision-making across Europe.
The meeting opened with welcome remarks by Claus Møldrup (DMA) and Julia Mader (MUG), setting the tone for two days of constructive exchange. A central highlight of the first day was a dedicated REDDIE session, which provided a comprehensive overview of the project, followed by presentations from the different work packages and an interactive discussion with participants. This session offered valuable insights into REDDIE’s objectives, methodological framework and ongoing activities, while also creating space for feedback from a diverse stakeholder audience.
The afternoon broadened the discussion to the wider European RWE landscape. Participants heard the industry perspective, explored joint MetReal insights under the theme “Evidence to Impact,” and reflected on the use of RWE in regulatory and HTA decision-making for both medicines and medical devices. The Q&A session that followed underscored a shared understanding: while numerous initiatives across Europe are actively advancing real-world evidence, stronger coordination and communication between projects are essential to maximise collective impact.
The second day shifted the focus towards practical implementation and future priorities. Discussions focused on the Lithuanian Health Data Reuse Pathway and the importance of linked data in generating stronger evidence, as well as perspectives on the use of patient registry data in medical decision-making. Interactive breakout sessions encouraged participants to engage more deeply with key strategic questions, including what type of evidence is most valuable for HTA and regulatory decisions, how RWE standards can be improved across products and diseases, and what future EU RWE projects should prioritise. The meeting concluded with a joint wrap-up and closing remarks, reaffirming the importance of continued collaboration within the MetReal Cluster and beyond.
By organising this multistakeholder meeting, REDDIE reinforced its commitment to fostering dialogue between projects and key decision-makers. The exchange clearly demonstrated that advancing real-world evidence in Europe requires not only robust methodologies and high-quality data, but also sustained cooperation and alignment across initiatives. REDDIE looks forward to continuing this collaborative effort to help shape a more coherent and impactful European RWE landscape.
