WP2 is where regulatory science meets real-world practice. Co-Led by the University of Oxford, University of Edinburgh and Bayer, this work package engages regulators and stakeholders to co-create evidence-based best practice recommendations as well as tools for using Real-World Data (RWD) and Real-World Evidence (RWE) in regulatory decision-making for medicines, medical devices, and drug-device combinations.
Regulatory bodies like the European Medicines Agency (EMA), National Competent Authorities (NCAs), and Notified Bodies ensure the safety, efficacy, and timely marketing authorisation of medicines and medical devices. However, challenges such as variability in data quality, methodological inconsistencies, and or lack of clarity of regulatory expectations (limited best-practice guidance) hinder the use of RWD and RWE in decision-making.
WP2 addresses these gaps by establishing a Stakeholder Regulatory Forum (launched on 2nd April 2026) to collaborate with regulators, healthcare professionals, patients, and industry experts, ensuring GREG’s guidance aligns with regulatory needs by identifying current and emerging RWD/RWE requirements.
It also compiles and analyses real-world examples of RWE use in regulatory evaluations through a general living library of case studies as well as deep dive analyses, covering the full lifecycle of medicines, medical devices, and drug-device combinations to serve as a foundation for practical recommendations and tools. A general living library is expected to increase visibility and learnings from regulatory precedents.
Additionally, WP2 works with WP1 to develop templates for regulatory submissions and RWE study design tools and collaborates with WP4 and WP5 to conduct regulatory Use Cases (UCs) to test and refine GREG’s practical recommendations and tools in real-world scenarios and with stakeholder feedback.
WP2 will demistify RWE for regulatory decision-making, providing clear, actionable tools and examples to build trust and accelerate development of innovative therapeutics and approvals. Collaborations with WP3 (HTA) ensure alignment between regulatory and HTA expectations, while WP6 supports testing use cases with the necessary data infrastructure.
Together with the Co-leads from University of Oxford, University of Edinburgh and Bayer, contributions to WP2 from Edwards Lifesciences, Pfizer, Uppsala Clinical Research Centre, the Aragonese Institute of Health Sciences, Erasmus University Medical Centre Rotterdam, Sanofi, Novo Nordisk, the GetReal Institute, Amgen, Medtronic, Bristol-Myers Squibb, and GSK are vital for the success of WP2 aims and ambitions.
By fostering collaboration between regulators, industry, and academia, WP2 ensures GREG’s outputs are practical, actionable, and aligned with decision-makers’ needs. The goal is to increase predictability and acceptability of RWE in regulatory evaluations, leading to faster patient access to safe and effective treatments across Europe.
In the coming years, expect tools, templates for RWE/RWD submissions, reflection papers, and lessons learned from Use Case analyses. Stay tuned for updates on WP2’s progress and its impact on the future of RWE in regulatory decision-making!
