Carlos Galamba
Chief Executive Officer & Head of Regulatory Affairs MDx CRO
Seminars
Wednesday 1st April 2026
Making IVDR Work in Combined Studies: Practical Lessons from 40+ Combined Programs at MDx CRO
12:50 pm
- Translate IVDR requirements into an operational playbook for combined CTR–IVDR studies
- Identify the critical decisions that determine whether a study starts smoothly or stalls in submission
- Apply lessons from 40+ combined programs to improve submission quality, reduce RFIs, and accelerate activation
- Understand how wave planning, country prioritisation, and parallel vs sequential EC/NCA models impact timelines
