Companion Diagnostics (CDx) – Navigating the Regulatory Challenges
10–11 December 2026 | Amsterdam

Day 1 – 10 Dec
08:45 – Registration & Coffee
09:00 – Welcome & Introductions
09:15 – Introduction to Precision Medicine
10:00 – US FDA Pathway for CDx
11:20 – EU Regulatory Framework for CDx
13:50 – CDx Device Performance
15:40 – EU Performance Study Authorisations
16:50 – Recap & Close (ends 17:00)

Day 2 – 11 Dec
08:45 – Registration & Coffee
09:00 – Recap of Day 1
09:15 – Workshop: Clinical Performance Study Authorisation
11:10 – Workshop: Conformity Assessment of CDx
13:30 – Future Changes in EU CDx Regulation
14:00 – Panel Discussion & Q&A
14:30 – Key Takeaways (ends 14:40)

The breaks are left out to keep it short. The trainers are Heather Johnson, Hilke Zander, Jörg Engelbergs, and Rolf Thermann.