Learn how to design a registration-ready clinical study. Built for approval, built for patient access.
A study that is suitable for publication or guideline development is not automatically suitable for marketing authorization. Hellen Houlleberghs, Orfenix’s clinical director will discuss what changes when the goal is registration of a product instead of just a publication. She will discuss what changes including: study design and endpoints, study preparation, CTIS readiness, GCP, IMP logistics, common pitfalls, timelines, and post-study obligations.
Participants will also receive the “From protocol to registration readiness scan”, a practical tool to identify potential gaps in their own study.
After this session you will:
- Clearly understand the difference between publishable studies and registration-ready studies
- Understand what submission readiness requires in practice, and the common validation pitfalls
- Recognise key execution risks during conduct (GCP expectations, deviations, monitoring, logistics/IMP)
- Leave with the “From protocol to Registration readiness scan” to pinpoint your top gaps and next actions
