DIA and the Regulatory Affairs Professionals Society (RAPS) just wrapped “2025 Combination Products in the EU,” a summit convening 28-29 January at the Radisson Grand Place in Brussels. With a focus on addressing challenges and creating efficiencies, the event attracted 150 participants from 23 countries for two days of discussions and idea exchange aimed at a coordinated drug and device approach to incentivise competitive innovation in Europe.

“It is beyond rewarding to hear from participants and speakers that the impact of this conference—the only one of its kind currently in Europe—is real beyond a shadow of a doubt,” said Pedro Barroca, Associate Director of Operations Transformation, Innovation, DIA. “Last year, the takeaways acknowledged gaps and the need and willingness to collaborate. This year, we have heard loud and clear that collaboration—particularly between regulators, notified bodies, and industry—is already happening in real-time, and it’s been going on for a while. This draws a strong parallel with the ongoing collaboration between DIA and RAPS, making these discussions and progress possible on the European stage.”

The programme for the summit was carefully curated by a planning committee of experts across the combination products community to ensure the highest quality discussions, knowledge exchange, and collaboration opportunities.

Esteemed 2025 Combination Products in the EU speakers included:
 

• Stiina Aarum, Scientific Officer, Scientific Advice and Protocol Assistance, European Medicines Agency (EMA) 
• Peter Bischoff-Everding, Legal Officer, European Commission
• Christelle Bouygues, Regulatory Affairs Senior Officer, European Medicines Agency (EMA)
• Orla Daly, Policy & Legal Officer, European Commission
• Flora Giorgio, Head of Unit, D3Medical Devices, DG SANTE, European Commission
• Virginia Rojo Guerra, Head of Procedures Office, European Medicines Agency (EMA)
• Lilia Luchianov, DG SANTE Policy Officer, European Commission
• Ana Trullas, Senior Scientific Specialist, European Medicines Agency (EMA)
• Ilona Reischl, CAT Chair & Biologics Quality Assessor, AGES, Austria

The full agenda consisted of 33 expert speakers across 13 interactive sessions showcasing the latest developments and opportunities in the sector. Sessions addressed critical topics, including Article 117 of the MDR, variations and lifecycle management, legacy CDx, availability of devices, Rule 14 and Rule 21, COMBINE programme, scientific advice and structured dialogue, CDx performance studies, future legislative changes, and AI. The event also featured a pre-conference workshop on Monday, 27 January, entitled “Introduction to Combination Products in the EU: Regulatory and Practical Insights.”

 

Kim Young, Regional Engagement Director, Regulatory Affairs Professionals Society (RAPS), commented, “Summit participants took the opportunity to really engage with each other, and it was rewarding to see the kernels of future solutions begin to unfurl before our eyes. I’m sure these conversations will continue based on relationships forged and strengthened over the two-day event.”

To learn more about 2025 Combination Products in the EU, visit www.eucomboprods.org.