eCTD (Electronic Common Technical Document).

Catalog description

The eCTD course details the Electronic Common Technical Document specification, provides guidance on the creation of the submission of an eCTD, and discusses the approach to regional differences in dossiers. The scope of the course for eCTD is to include information on variations, renewals, and amendments, so that it is no longer a static document but is updatable throughout the life of the product. The module provides training and reference tool that will be of particular value to those new to the use of the format. This can be of assistance to anyone involved with electronic submissions and in navigating these changing requirements. Examine the structure of the Common Technical Document (CTD) format through study of both regulatory requirements as well as example submissions. This is a hybrid course (>50% online) with distance-learning lectures and Canvas assignments. Prerequisites: Graduate student standing in the PCSP program or permission by instructor.