The Electronic Common Technical Document (eCTD) - Building Comprehensive Functionality for Effective Implementation

This course is designed as a review of current regulatory guidelines and how they affect strategies in the development, preparation, and successful submission of eCTDs.  The foundation of the CTD’s organization, structure, and granularity are explained, along with their applicability on templates and submission-ready sections and reports.  The program also explores modularity of submission components, and their applicability to lifecycle management for multi-region submissions.

Through presentations, interactive discussions, and review of real-life scenarios, the program covers the practical elements of building eCTDs, from structural and technical requirements to procedural and tactical planning that have been put into practice on successful applications.  Technical elements, such as data formats, checksum function, validation criteria, and metadata requirements, are covered from an end-user perspective, with their practical implications clearly explained.  In addition, participants will gain insight on assessing tools used in the preparation and completion of electronic submissions.