VPH at RAPS EURO CONVERGENCE 2026 – Navigating the future of regulation
Our scientific officer, Janaki Raman, joined the global regulatory affairs community in Lisbon for RAPS Euro Convergence 2026 โ and in silico medicine was firmly on the agenda.
Marking the 50th anniversary of the Regulatory Affairs Professionals Society (RAPS), the conference opened with a forward-looking session on the evolution of healthcare regulation. Against a backdrop of sweeping legislative change across Europe, the opening panel struck a consistent note: implementation, collaboration, and co-creation matter more than legislation alone.
Panel: “Evolution of Legislation” โ moderated by Suzanne Halliday (BSI)
- Implementation over legislationย โ Santos Ivo (INFARMED) reminded attendees that while legislation changes, success lies in coordination, implementation, and delivery.
- Unity in diversityย โ Steffen Thirstrup (EMA) advocated for leveraging Europe’s diversity as a strength in navigating complex regulatory decisions, while cautioning against overregulation.
- Patient readiness โ Valentina Strammiello (European Patients Forum), a close collaborator of the VPH Society, addressed persistent gaps in patient engagement and affirmed that patients are ready to embrace innovation and its inherent risks โ provided early dialogue is prioritised.
- From dialogue to co-creationย โ Prof. Maren von Fritzschen (HTW Berlin) emphasised the shift from an “us vs. them” dynamic to genuine partnership through co-creation, including the use of regulatory sandboxes.
The session highlighted two landmark milestones providing regulatory clarity on CM&S as clinical evaluation evidence: the European Commission’sย Advanced Virtual Human Twin platformย and the currentย MDR revision proposals. Together, these signal a pivotal shift โ computer modelling and simulation are increasingly recognised alongside traditional clinical evidence sources in regulatory submissions.
For the VPH Society, this convergence of regulatory momentum and scientific maturity represents the culmination of years of advocacy: healthcare is now actively pivoting toward computational modelling, simulation, and digital twins to de-risk health technologies before they reach patients.
In the picture: Janaki R. Raman – VPH; Philippe Favre – Zimmer Biomet; Okan Avci – Fraunhofer IPA
