On 6-8 May 2024, the VPHi team participated to the European regulatory congress – RAPS Euro Convergence, where policy, regulatory and industrial stakeholders joined hands to share ideas, knowledge and collaborate to advance healthcare regulatory practice.
The European regulatory congress – RAPS Euro Convergence was organised by the Regulatory Affairs Professionals Society (RAPS), bringing together key-opinion leaders from regulators (EMA), policy makers (EC), national competent authorities (NCA) and conformity assessment agencies, but also members of the notified bodies (NB) as well as professionals from pharmaceutical, medical devices and in vitro device industries.
The three-day program included parallel tracks for pharma, devices and IVD sectors, with a mix of key-notes and live panel discussions that debated the fast-evolving policy landscape, including the AI act. While the challenges and bottlenecks with the adoption of MDR continued to spark concerns, it was also encouraging to see the marked progress made in the last year. For instance, concerns on increasing cost, risk of device availability were echoed across the spectrum. At the same time, the preliminary roll-out of EUDAMED and increased capacity of notified bodies hit positive notes. The community was acknowledging the shortcomings, but also emphasized the need to brace in unity to navigate the (in-)compatibility of MDR and horizontal acts (AI act, Data act, etc.).
RAPS Euro convergence was an opportunity to mutually learn and establish bridges for the wider in silico medicine community. It offered an engagement with policy makers, regulators and members of the notified bodies, to understand their key perspectives and concerns. Learnings included quick wins through the mechanism of medical device coordination group guidelines to overcome some barriers, as well as the need to rally the in-silico community to join the discussions on emerging technologies, within the regulatory arena.
