Clinical & Non-Clinical Studies (M4 & M5 of CTD) Review for Regulatory Personal

This course provides regulatory professionals with a practical review of Module 4 (Non-Clinical Study Reports) and Module 5 (Clinical Study Reports) of the Common Technical Document (CTD). Participants will learn how to interpret study data, assess compliance with international guidelines (ICH, FDA, EMA), and evaluate dossiers for accuracy and completeness, enabling more effective regulatory review and decision-making.  The course uses different ways of delivering knowledge like case studies,  exercises, and individual tests. At the completion of the course, the skills that YOU will have are practical, applicable, and implementable. You can find the course outline in the video above