eCTD & CTD Preparation & Submission Course

Course Feature

Cost

Paid
Provider

Udemy
Certificate

Paid Certification
Language

English
Start Date

2022-03-08
Learners

No Information
Duration

No Information
Instructor

Mahesh Pratapwar

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4.1

3,331 Ratings

This eCTD & CTD Preparation & Submission Course is the perfect way to gain a comprehensive understanding of the Electronic Common Technical Document (eCTD) specification. Learners will gain an understanding of the creation of an eCTD submission, and an overview of regional differences in dossiers. 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 Assistance, Regulatory Affairs Head/Director, and Medical Information. This course 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. Don't miss out on this great opportunity to gain the skills and knowledge needed to pursue a career in Regulatory Affairs.

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Course Overview

❗The content presented here is sourced directly from Udemy platform. For comprehensive course details, including enrollment information, simply click on the 'Go to class' link on our website.

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)

Congratulations & Thank you

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