A study that is suitable for publication or guideline development is not automatically suitable for marketing authorisation. 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.

Visit the website for more information: https://orfenix.com/webinar-how-do-you-design-a-clinical-study-that-is-registration-ready/

 Registration link: https://events.teams.microsoft.com/event/b00fe972-6382-435a-8b8c-19b6abf772f0@5b8666c1-d3a4-4d81-841c-691b9585ca11