100 Global Regulators, Health Authorities, Notified Bodies and Industry Partners Gather in Brussels for 2026 Combination Products in the EU

Brussels — 29 January 2026 — DIA and the Regulatory Affairs Professionals Society (RAPS) just wrapped the “2026 Combination Products in the EU,” a summit convening 27-28 January at the Radisson Grand Place in Brussels. With a focus on addressing challenges and creating efficiencies, the event attracted more than 100 participants from 16 countries for two days of discussions and idea exchange aimed at a coordinated drug and device approach to incentivise competitive innovation in Europe.

Now in its third year, this programme has consistently looked beyond education, and more towards transformation through building understanding across stakeholder groups. “That’s the whole idea of working together. We learned a lot of things throughout the years of implementation. We learned a lot of things through the evaluation, by collecting cases, and facts,” said Flora Giorgio, Head of Unit Medical Devices, DG SANTE, Medical Products and Innovation. “I think everybody is very keen in having a more harmonized approach.”

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.

Speakers from notified bodies and health authorities were represented at the 2026 Combination Products in the EU summit, including:

• Stiina Aarum, Senior Scientific Specialist, European Medicines Agency (EMA)
• Arabe Ahmed, Medicinal Technical Expert and Scheme Manager, BSI Group
• Nada Alkhayat, Policy Officer, Medical Devices, European Commission (EC)
• Miguel Antunes, Senior Scientific Specialist, European Medicines Agency (EMA)
• Antonella Baron, Senior Product Lead and Companion Diagnostic Topic Lead, European Medicines Agency (EMA)
• Christelle Bouygues, Regulatory Affairs Senior Officer, European Medicines Agency (EMA)
• Radhouane Cherif, Senior International Liaison, European Medicines Agency (EMA)
• Peter Bischoff Everding, Senior Expert, Medical Devices Unit, European Commission (EC)
• Sebastian Fischer, Regulatory Strategy Principal, TÜV SÜD Product Service GmbH
• Flora Giorgio, Head of Unit Medical Devices, DG SANTE, Medical Products and Innovation, European Commission (EC)
• Virginia Rojo Guerra, Head of Procedures Office, European Medicines Agency (EMA)
• Sabina Hoekstra-van den Bosch, Global Director Regulatory Strategy, TÜV SÜD 
• Veronika Jekerle, Head of Pharmaceutical Quality, Quality and Safety, Human Medicines, European Medicines Agency (EMA)
• Alberto Ganan Jimenez, Head of Committees and Quality Assurance, European Medicines Agency (EMA)
• Katrine Bering Klausen, Policy and Stakeholder Engagement – Teamleader, Danish Medical Agency (DKMA)
• Therese Klamer, Regulatory Project Leader, Medicines Evaluation Board (MEB)
• Alex Laan, Head of the IVD Notified Body, BSI Group
• Chiara Orlandi, Policy and Legal Officer – Directorate-General for Health and Food Safety (DG SANTE), European Commission (EC)
• Carmen Ruiz-Villar, Deputy Director Medical Devices Department, Spanish Agency for Medicines and Medical Devices
• Jonathan Sutch, Principal Medicinal Technical Specialist, BSI Group
• Olga Tkachenko, Policy Officer, European Commission (EC)
• Marie Valentin, Team Lead, Facilitated Product Introduction, WHO

The full agenda consisted of 43 expert speakers across 12 interactive sessions showcasing the latest developments and opportunities in the sector. Sessions addressed critical topics like lifecycle management, global harmonization, IVDs non-CDx, environmental sustainability, precision medicine and IVDs, the future of MDR and IVDR revisions, COMBINE, medical device software, IVD legacy diagnostics, and lessons learned. The event also featured a pre-conference workshop on Monday, 26 January, entitled “Introduction to Combination Products in the EU: Regulatory and Practical Insights.”

When examining what is possible to build a better system together, Amanda Matthews, Executive Director, Head of Regulatory for Combination Products & Medical Devices, Pfizer R&D UK, Ltd. was optimistic and commented that “what we do hope from an industry perspective, is that we see a regulator response that enables us to navigate this complex landscape with greater efficiency, and ultimately, for the benefit of patients across Europe. It's great to see some of the progress already with regards to COMBINE and the legislation reform, but it's not really where we can stop.”

To learn more about 2026 Combination Products in the EU, visit www.eucomboprods.org.

ABOUT DIA
DIA is a leading global life science membership association that drives collaboration in drug, device, and diagnostics development in pursuit of a healthier world. Founded in 1964 with headquarters in Washington, D.C., and offices in Europe and Asia, DIA provides unparalleled networking opportunities, educational resources, scientific research publications, and professional development programs to members in more than 80 countries.

Learn more at DIAglobal.org, and connect with DIA on LinkedIn, Facebook, X (Twitter), and Instagram.

ABOUT REGULATORY AFFAIRS PROFESSIONALS SOCIETY (RAPS)
The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of professionals involved with regulatory and quality for healthcare products, including medical devices, pharmaceuticals and biologics, diagnostics, and digital health. Founded in 1976 as a neutral, nonprofit organization, RAPS supports and elevates the regulatory profession with education and training, professional standards, publications, research, networking, career development, and other valuable resources. RAPS is home to the Regulatory Affairs Certification (RAC), the only post-academic professional credential to recognize regulatory excellence. The society is headquartered in suburban Washington, D.C., with chapters and affiliates worldwide. www.raps.org