2nd Annual European Combination Products Regulation Conference, 18th & 19th September 2025

2nd Annual European Combination Products Regulation Conference TT Group's 2nd Annual European Combination Products Regulation Conference, guided by regulatory officials and industry leaders, explores cutting-edge strategies, decodes Notified Body Opinions, and addresses global trends. Dive into pivotal subjects like the Competent Authority Perspective on clinical investigation applications, Article 117 for MDR compliance, and the regulatory implications of SaMD / AI. Unravel complexities in DDC, Marketing Authorization Application (MAA) submission processes and immerse yourself in engaging sessions with real-world examples. This conference ensures actionable insights for overcoming regulatory challenges in the combination products landscape, featuring interactive presentations, Q&A sessions, and networking opportunities with industry experts. 18 – 19 September 2025 DAY1 08:00 – 17:15 CET DAY 2 08:30 – 15:40 CET