CTD NeeS & eCTD compilation and submission of the dossiers

Course Feature

Cost

Free
Provider

Udemy
Certificate

No Information
Language

English
Start Date

2021-11-11
Learners

No Information
Duration

No Information
Instructor

Asmaa Khalil El-Kersh

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4.1

1,199 Ratings

This course provides a comprehensive overview of CTD, NeeS & eCTD, the unified global registration system for pharmaceutical and biological products. It explains the rationale for the CTD, NeeS & eCTD, and provides detailed guidance on its structure and format. Participants will learn how to prepare submissions to regulatory authorities in all countries or regions where the CTD/NeeS/eCTD formats are mandatory, recommended or accepted. The course also covers the differences between CTD, NeeS & eCTD, CTD/eCTD history, and criteria of dossier preparation. By the end of the course, participants should be able to confidently prepare and submit CTD/NeeS/eCTD dossiers.

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CTD NeeS & eCTD compilation and submission of the dossiers

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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 course provides an overview of the Common Technical Document (CTD), NeeS and eCTD formats, which are mandatory for regulatory submissions worldwide. It explains the rationale for the CTD, NeeS and eCTD, and provides detailed guidance on their structure and format. Several MENA authorities have implemented eCTD/NeeS or CTD as a submission format for pharmaceutical products, and many global authorities (Ministries of Health) have implemented CTD submission as a standard guideline for product registration. Pharmaceutical companies looking to export their drug products must be familiar with the implementation of the unified global registration system, CTD, and must know how to prepare their pharmaceutical/biological registration files to comply with the global unified registration system. Upon completion of this course, participants should be able to: * Prepare submissions to regulatory authorities in all countries or regions where the CTD/NeeS/eCTD formats are mandatory, recommended or accepted. * Understand the differences between CTD, NeeS & eCTD. The course outline includes: 1. Role of regulatory affairs. 2. Definition and difference between CTD, NeeS & eCTD. 3. CTD/eCTD history. 4. Organization of CTD (Module 1, 2, 3, 4, & 5) 5. Criteria of dossier preparation.

Course Syllabus

Introduction

Journey to CTD NeeS eCTD submissions 2

Journey to CTD NeeS eCTD submissions 3

Journey to CTD NeeS eCTD submissions 4

Journey to CTD / NeeS / eCTD submissions 4

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