Designed to build on the foundation provided in RAPS’ Preparing Compliant eCTD Submissions Workshop, this interactive, hands-on advanced training seminar will provide the experience of compiling an eCTD submission for FDA, repurposing the content for submission to EMA, and demonstrate the challenges and benefits of using document granularity over a drug submission’s lifecycle. Expert instructors will teach participants about the detailed contents of all modules of the eCTD, the differences in Module 1 for the US, Canada, and Europe, and how regional differences impact Modules 2 through 5.