Brussels — 31 January 2024 — DIA and the Regulatory Affairs Professionals Society (RAPS) just wrapped “2024 Combination Products in the EU,” a summit convening 30-31 January at the Radisson Grand Place in Brussels. The event was the first ever collaboration between the two organizations and attracted 130 participants from 17 countries for two days of discussions and idea exchange focused on a coordinated drug and device approach to incentivise competitive innovation in Europe.

“RAPS and DIA are both parts of an ecosystem of organizations whose approaches can be different, but whose missions are often aligned,” said Brian Savoie, Senior Vice President, Education & International Programs, Regulatory Affairs Professionals Society (RAPS). “With broad endorsement by the leadership and membership of both organizations, we were pleased to see so many professionals from across the industry come together for vital conversations focused on finding solutions and creating efficiencies.”

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. The agenda consisted of 27 expert speakers across eight interactive sessions, showcasing the latest developments, opportunities, and critical issues in the sector.

Sessions addressed various nuances of MDR and Article 117, the development of medicinal products with co-packaged devices/cross-referenced devices, the impact of new EU general pharma legislation, harmonized interpretations, the future of patient care, and medical devices in medicinal product clinical trials.

Featured speakers included:

• Stiina Aarum, Scientific Officer, Scientific Advice and Protocol Assistance, European Medicines Agency
• Christelle Bouygues, Regulatory Affairs Senior Officer, European Medicines Agency
• Isabelle Clamou, Policy Officer, DG Sante Unit D2 – Medicinal Products, European Commission
• Björn Eriksson, Director General, Swedish Medical Products Agency
• Flora Giorgio, Head of Unit, D3Medical Devices, DG SANTE, European Commission
• Lars Hyveled-Nielsen, Regulatory Project Director, Zealand Pharma
• Lilia Luchianov, Policy Officer DG Sante, European Commission
• Ilona Reischl, CAT Chair & Biologics Quality Assessor, AGES, Austria/li>
• Jonathan Sutch, Principal Medicinal Technical Specialist, BSI, UK
• Olga Tkachenko, Policy Officer, DG Sante Unit D3 – Medical Devices, European Commission
• Pascal Venneugues, Principal Scientist, European Medicines Agency

“The overwhelming themes throughout the presentations and working groups centered on collaboration, interaction, trust, understanding, dialogue, action and consensus among stakeholders,” said Nathalie Preiswerk, Associate Director and Head of Scientific Programs, DIA Global. “We feel confident that 2024 Combination Products in the EU helped to stimulate ideation and innovation around designing solutions for pragmatic implementation, and we look forward to more joint collaborations with RAPS in the future.”

To learn more about 2024 Combination Products in the EU, visit www.eucomboprods.org.