Electronic Common Technical Document (eCTD)

Online Course • grapl

About the CPD course

The eCTD specification has been developed to facilitate the global electronic submission; review and lifecycle management of medicinal product dossiers for regulatory applications. Use of the eCTD is mandatory for all applications for marketing approval and all subsequent related submissions in the European Economic Area; the USA and Canada. 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.

CPD Provider

grapl

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grapl

grapl is a UK based digital learning and development specialist, authoring and designing Zenosis® courses to provide an extensive eLearning library for the pharmaceutical, biotech and medicinal products sector. This learning can be delivered via the customers LMS, the grapl LMS or its social, knowledge and collaborative CloudRooms platform. Continuously updated to reflect regulatory changes, Zenosis® courses are trusted to educate their people by some of the worlds leading companies.