eCTD & CTD Preparation & Submission Course faq

star-rating
4.1
learnersLearners: 3,331
instructor Instructor: Mahesh Pratapwar instructor-icon
duration Duration: duration-icon

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 Feature Course Overview Course Provider Discussion and Reviews
Go to class

Course Feature

costCost:

Paid

providerProvider:

Udemy

certificateCertificate:

Paid Certification

languageLanguage:

English

start dateStart Date:

2022-03-08

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

Course Provider

Provider Udemy's Stats at AZClass

Discussion and Reviews

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faq FAQ for Pharmaceutical Industry Courses

Q1: Does the course offer certificates upon completion?

Yes, this course offers a paid certificate. AZ Class have already checked the course certification options for you. Access the class for more details.

Q2: How do I contact your customer support team for more information?

If you have questions about the course content or need help, you can contact us through "Contact Us" at the bottom of the page.

Q3: How many people have enrolled in this course?

So far, a total of 3331 people have participated in this course. The duration of this course is hour(s). Please arrange it according to your own time.

Q4: How Do I Enroll in This Course?

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