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Real-world-data enabled assessment
for health regulatory decision-making

REALM engages with stakeholders at ISPE 2026 and VPH 2026

REALM recently participated in two international events bringing together experts working on real-world data, digital technologies and the future of healthcare: the ISPE Annual Meeting 2026 and the VPH 2026 conference in Milan.

On 31 August, REALM was represented by Gökhan Ertaylan, REALM co-coordinator from VITO, at ISPE 2026. Gökhan contributed to a presentation of a joint paper including projects from the MetReal Cluster:

“Towards the use of real-world data for regulatory and health technology assessment decision-making: Results from five EU-funded projects.”

The joint presentation brought together perspectives from REALM, REDDIE, More-EUROPA, Real4Reg, ONCOVALUE and INSAFEDARE. It highlighted how EU-funded projects are working to advance the use of real-world data and real-world evidence in regulatory and health technology assessment decision-making.

Gökhan presented REALM’s work on the federated evaluation of medical software devices, including AI-based technologies.

The presentation was very well received, attracting a large audience and generating an active discussion. Participants raised many questions and expressed interest in the role of real-world data in different regulatory and healthcare settings. We received a lot of questions and follow-up interest, which showed the growing recognition of the importance of using real-world data in different settings.

The event also provided an opportunity to present REALM to a broad audience of professionals working in regulatory science, health technology assessment and health data research. The strong interest in the joint presentation demonstrated the value of collaboration between projects addressing related challenges from different perspectives.

A few days later, REALM was represented at VPH 2026, the 9th International Conference on the Virtual Physiological Human, held in Milan from 1 to 4 September. The conference was organised by VPH Institute, a REALM project partner, and focused on the adoption of digital twins in healthcare.

REALM presented its work at an exhibition booth, where Gökhan Etarlyan and Janaki Rangarajan engaged with researchers, developers and representatives from start-ups working on software medical devices. Many visitors asked how they could use the REALM platform, test their technologies and access relevant data. These conversations provided valuable feedback and helped validate the direction of the project. They also highlighted the continuing need for independent evaluation of medical software and AI-based technologies.

“The people we met at VPH 2026 are the kind of stakeholders who could use REALM,” Gökhan explained. “They were asking how they could test their technologies, how they could access the platform and what types of data would be available. This was a good validation of the work we are doing.”

The conversations at VPH 2026 also highlighted a continuing gap in the healthcare innovation ecosystem: the need for independent evaluation of software medical devices and AI-based technologies.

Together, the two events enabled REALM to engage with complementary audiences. While the ISPE joint presentation connected the project with experts in regulatory and health technology assessment decision-making, the VPH exhibition provided an opportunity to engage directly with researchers and developers building the next generation of digital health technologies.

The discussions confirmed the relevance of REALM’s work and the importance of continued collaboration between research projects, regulators, technology developers and healthcare stakeholders. As the project progresses, REALM will continue working towards making its tools and results available to the wider community.

ISPE 2026