130 Global Regulators, Health Authorities, Notified Bodies and Industry Partners Gather in Brussels for 2024 Combination Products in the EU

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
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
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.

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ABOUT DIA
DIA (founded as the Drug Information Association) is a global association that mobilizes life science professionals from across all areas of expertise to engage with patients, peers and thought leaders in a neutral environment on the issues of today and the possibilities for tomorrow. As a member-driven, volunteer organization, professionals from 80 countries have affected healthcare outcomes, by engaging with DIA through an unparalleled network, educational offerings, and professional development opportunities.

DIA is based in Washington, DC (US) with regional offices representing the Americas (Horsham, PA, US); Europe, the Middle East, and Africa, (Basel, Switzerland); and Asia (Beijing and Shanghai, China; Mumbai, India; and Tokyo, Japan).

Learn more at DIAglobal.org and connect with DIA on Twitter, LinkedIn, Facebook, 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

130 Global Regulators, Health Authorities, Notified Bodies and Industry Partners Gather in Brussels for 2024 Combination Products in the EU

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