Advanced eCTD Submissions

Designed to build upon 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 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. Attendees will also learn how eCTD submissions in the research and development phase differ from those for marketing applications.

By participating in this workshop, you will not only learn how to strategically prepare submissions for US, Europe, and Canada health authorities, but you will assess and improve submission processes, workflow and teamwork to achieve less stress and cost to your organization.