The eCTD is mandatory for all applications for marketing approval and all subsequent related submissions in the European Economic Area, the USA and Canada. Other countries intend to make its use mandatory. The eCTD specification has been developed to facilitate the global electronic submission, review and lifecycle management of medicinal product dossiers for regulatory applications. It broadens the scope of the CTD 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. This module outlines the eCTD specification, discusses the approach to regional differences in dossiers, and provides guidance on creation of an eCTD submission. The module provides a training and reference tool that will be of particular value to those new to the use of the format.
Level 3 & 5 Endorsed Diploma | QLS Hard Copy Certificate Included | Plus 5 CPD Courses | Lifetime Access
Premium Bundle of all Time | Ofqual Regulation + NCFE Awards + CPD Accreditation | Assessment & Tutor Support Included
3 QLS Endorsed Diploma | QLS Hard Copy Certificate Included | 10 CPD Courses with Certificates | Installment Options