DIA and RAPS are excited to collaborate for the first time to jointly produce the 2024 summit on Combination Products in the EU. This highly-interactive summit will unite key stakeholders across the field - including representatives from EMA, the European Commission, Notified Bodies, National Competent Authorities and Industry - to explore a coordinated drug and device approach for bringing innovation back to Europe.
With a distinct focus on finding solutions and creating efficiencies, the 2024 summit on Combination Products in the EU offers attendees a comprehensive overview of the current status of the EU MDR implementation, examining the nuances of Article 117 and discussing the process of obtaining notified body and competent authority opinions. In addition, the event provides a unique forum for discussing the implications of the new EU Pharmaceutical Legislation on bringing combination products to market.
Throughout the summit, experts will exchange ideas via action-oriented working groups that stimulate ideation and innovation, designing solutions for pragmatic implementation.
By exploring current challenges and opportunities to unite for better pathways forward, the programme will highlight critical topics such as labelling, connected devices, software as a medical device, clinical trials, post-marketing clinical follow-ups, sustainability, and the application of Human Factors Engineering.