Academic research can produce promising results. However, when the aim is to obtain marketing authorisation for a therapy and make it available to patients, a study must meet additional requirements. These include appropriate endpoints, GCP-compliant conduct, CTIS readiness, data quality and investigational medicinal product logistics.

On 13 October at 16:00 CEST, Orfenix will host the webinar How do you design a clinical study that is registration-ready?

Hellen Houlleberghs, Clinical Director at Orfenix, will discuss the main considerations, common pitfalls and post-study obligations. Using guanabenz as a case study, she will also demonstrate how these choices affect clinical development in practice.

This topic reflects an important challenge for RARE-NL and Medicijn voor de Maatschappij: how can we ensure that promising academic research does not end with a publication, but progresses towards an accessible treatment?

More information:
https://orfenix.com/webinar-how-do-you-design-a-clinical-study-that-is-registration-ready/