The holder of this certificate has attended the course "Regulatory Affairs Strategies During Development".

This course aims to assist you in choosing the optimal registration strategy for your product based on the product type, indication, and your company’s objectives. You will explore your role during the clinical and CMC phases of development and in preparation for MAA. Additionally, you will examine specific guidelines that will direct your early phase strategy such as ATMP, orphan designation, oncology, and paediatric. By the end of this course, you will have the necessary skills and confidence to navigate towards fast approval, which can translate to significant cost savings.