GetReal Institute

EU Legislative Interests

GetReal activities are mainly focused on the following EU legislations: 1. The European Union (EU) legal framework for pharmaceuticals (Regulation (EC) No 726/2004) 2. Regulation on Health Technology Assessment – Regulation (EU) 2021/2282 3. Proposal for a regulation – The European Health Data Space (COM(2022) 197/2) 4. A pharmaceutical Strategy for Europe (COM(2020) 761 final) Potentially GetReal Institute will focus on the following legislations as well: 5. Legislation around the use of the AI act 6. Data Act The GetReal Institute focuses on advancing the generation and use of real-world evidence (RWE) to support regulatory and health technology assessment (HTA) decision-making within the evolving European policy landscape. Part of its work examines how key EU frameworks influence evidence requirements, methodological standards, and decision-making processes across the product lifecycle. In parallel, the Institute assesses the implications of these frameworks for different stakeholder groups, including regulators, HTA bodies, industry (including SMEs), academia and patients, with particular attention to feasibility of evidence generation, access to data, and the meaningful integration of patient perspectives. Through its activities, including conferences, workshops, webinars, research and publications, the GetReal Institute facilitates dialogue, disseminates best practices, and translates methodological advances into actionable insights for stakeholders operating within these EU policy contexts.

Communication Activities

Communications and Stakeholder Engagement Activities The GetReal Institute delivers a range of communication and engagement activities designed to advance understanding and practical application of real-world evidence (RWE) across Europe. Through its education and training initiatives, including the GetReal Academy and Shared Learning Forum, the Institute develops targeted learning materials and platforms to build capacity in the generation and use of RWE among stakeholders. A central component of its work is the Shared Learning Forum, a multi-stakeholder platform that brings together regulators, HTA bodies, researchers, clinicians, industry, and patients. The Forum enables open dialogue, exchange of experiences, and the development of best practices, supporting greater alignment and trust in the use of RWE for decision-making. The annual GetReal Conference serves as a central event in our calendar, convening regulators, HTA representatives, and other stakeholders to explore policy developments and practical challenges in applying RWE. Discussions focus on real-world implementation, including preparedness for evolving EU frameworks and the translation of RWE into decision-ready evidence. The Institute promotes awareness of European policy and data initiatives through its communication activities and facilitates informed dialogue on their implications for real-world evidence (RWE). Through multi-stakeholder webinars and related activities, it provides a platform for timely exchange, knowledge sharing, and dissemination of best practices. The Institute is also a member of the GREG consortium, supporting broader stakeholder engagement across the European RWE ecosystem. Across all activities, the Institute works in partnership with stakeholders from regulatory authorities, HTA bodies, industry, academia, and patient organisations to develop practical outputs and foster a shared understanding of how RWE can support high-quality, sustainable healthcare decision-making in Europe.

Interests Represented

Does not represent commercial interests

Member Of

N/A

Organisation Members

List of current member organisations can be found on our website: https://getreal-institute.org/people/#members