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Updated in [July 27th, 2023]
This eCTD & CTD Preparation & Submission Course provides learners with a comprehensive understanding of the Electronic Common Technical Document (eCTD) specification, guidance on the creation of an eCTD submission, and an overview of regional differences in dossiers. It is a valuable training and reference tool for those new to the use of the format, and can be of assistance to anyone involved with electronic submissions and navigating changing requirements. Upon completion of the course, learners will receive a certificate of completion and be equipped with the knowledge to pursue job opportunities in Regulatory Affairs, such as Regulatory Affairs Associates, Regulatory Affairs Assistants, Regulatory Affairs Heads/Directors, and Medical Information professionals. This course is designed to provide learners with the necessary skills and knowledge to effectively create and submit eCTD and CTD documents.
Course Syllabus
Introduction
Module 1 (Administrative part - Region Specific)
Module - 2 (Summary & Overview)
Module -3 (Quality)
Module 4 (Non-Clinical Study)
Module 5 (Clinical Study)
eCTD Structure (Template as per software)
eCTD Software General demonstration
Electronic Submission Gateway (ESG)
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