Nordic LNG In Person Event: Advancing Health Technology: Navigating Regulatory Challenges for Drug-D

Join us for the upcoming RAPS Nordic Local Networking Group (LNG) physical event hosted at Novo Nordisk HQ in Bagsværd, Denmark, on 27 November 2025. This free, half-day gathering will explore critical regulatory challenges for innovative health technologies - specifically Drug-Device Combination Products and AI/ML-Enabled Medical Devices.

The event will explore the challenges of navigating the regulatory landscape for emerging technologies - such as combination products and AI/ML-enabled medical devices - particularly in areas where standardization and guidance remain slow to develop or fragmented in interpretation.

The event will consist of two targeted presentations, followed by a panel discussion featuring representatives from Notified Bodies and Competent Authorities only.

• Presentation 1: This presentation explores how adopting a platform approach can enhance regulatory compliance in the development of integrated Drug-Device Combinations (iDDCs) and medical devices.
• Presentation 2: This session dives into the challenges of benefit-risk determination for AI/ML-enabled medical devices, providing an overview of emerging guidance and standardisation efforts in clinical and performance evaluation.
• Panel Discussion and Q&A: This session will address the ongoing regulatory uncertainty surrounding clinical evidence requirements for AI/ML-enabled medical devices and the broader compliance challenges for combination products.

Attendees will have the opportunity to engage with Competent Authorities and Notified Bodies, network with peers, and enjoy a networking session with complimentary snacks and beverages.