RGA 6670 — Global Impact of Electronic Common Technical Document (eCTD) Submissions
3 semester hoursGraduateLecture
Examines the structure of the Common Technical Document format documents through the study of both regulatory requirements and example submissions. Offers students an opportunity to develop an understanding of the FDA's geographically specific eCTD submission requirements. Reviews the basic structure and format of an eCTD submission and the differences between the electronic format and former paper-based CTD submissions.