REALM at Multi-Stakeholder Workshop on RWD in Regulatory & HTA Decision-Making
On February 6th, members of the MetReal cluster organised the first Multi-Stakeholder Workshop on Real-World Data (RWD) in Regulatory and Health Technology Assessment (HTA) Decision-Making at BfArM in Bonn, Germany.
The event, hosted by Real4Reg in collaboration with Insafedare, More-EUROPA, ONCOVALUE, REDDIE and REALM, brought together a diverse group of stakeholders, including regulatory and HTA agencies, academia, the representatives from the European Commission, industry representatives, patient organisations, payers and key initiatives focused on advancing RWD adoption in Europe. The REALM coordinators Dr Michel Dumontier and Dr Gökhan Ertaylan together with Dr Chang Sun, were representing the REALM consortium.
The discussions centred on leveraging RWD to generate real-world evidence (RWE), enhance regulatory decision-making, and strengthen competency-building among researchers and regulatory bodies.
Workshop Highlights
The event featured insightful presentations on early project results, as well as an in-depth examination of two real-world data use cases. During the session on RWD use cases from the MetReal cluster, REALM co-coordinator Gökhan Ertaylan presented the Pharmacogenomics Passports to Practice (PGx2P) use case, offering key insights into its potential impact on regulatory frameworks.
Advancing Training & Capacity-Building
A key takeaway from the discussions was the importance of training and guidance strategies to equip regulators, HTA bodies, and other stakeholders with the expertise needed to implement RWD effectively. As part of this effort, the REALM collaborative framework is evolving to support the joint development and evaluation of innovative medical device software by regulatory authorities, software developers, healthcare professionals, and policymakers. A major initiative within this framework is the launch of the REALM Academy—an online educational platform designed to provide:
- Training & capacity-building for regulatory and HTA bodies
- Technical implementation guidance
- Data quality frameworks & best practices
- Ethical, legal, and societal considerations in Medical Device Software
The REALM Academy’s training schedule and upcoming workshops will be announced here.
The Role of RWD in Improving Healthcare Decision-Making
Stakeholders emphasised that while RWD is not a one-size-fits-all solution, it is a critical tool for improving patient care and healthcare decision-making. Having real-world insights is far superior to relying solely on limited clinical data or assumptions.
The REALM consortium appreciates all attendees for their valuable contributions and meaningful discussions. The engagement and expertise demonstrated during the workshop underscore a shared commitment to strengthening regulatory support and building a robust evidence framework to advance healthcare decision-making.