CTD Training Course
Introduction
This course is designed to provide a thorough understanding of the Common Technical Document (CTD), which is an internationally recognized standard for the preparation of regulatory submissions for pharmaceuticals. Participants will gain knowledge on the structure, content, and requirements of the CTD, as well as practical skills for compiling and submitting CTD dossiers to regulatory authorities.
Objective
- Understand the purpose and importance of the CTD format.
- Familiarize with the structure and content of the CTD modules.
- Learn the detailed requirements for each section of the CTD.
- Gain practical skills in compiling and organizing CTD dossiers.
- Understand the regulatory submission process and requirements in different regions (e.g., FDA, EMA, EDA).
- Address common challenges and best practices in CTD preparation.
Target Audience
- Regulatory affairs professionals
- Quality assurance specialists
- Drug development specialists
- Anyone involved in the preparation and submission of regulatory documents.
Course Materials
- Comprehensive course handbook
- PowerPoint presentations
- Templates and checklists for CTD preparation
Certification
Certificates of completion will be awarded to participants who successfully complete the course.
Course Contents
1. Introduction to ICH and CTD
2. Overview of local regulations and ministerial decrees related to CTD.
3. Overview of Common Technical Document (CTD) dossier
o Outline the basic CTD format and content (Modules 1 to 5).
4. CTD Module (1)
o Submission guidance for Module 1
5. CTD Module (3) | Quality Module (Detailed review for the guidelines of documentation and submission of pharmaceutical products in CTD format)
o S-Part
o P-Part
o A-Part
o R-Part
6. CTD Post License Variations
7. Practical Workshop
o Preparation and submission of CTD files according to EDA guidance and reception checklist.
o Validation and Review of a Dossier.
o Soft File Arrangement Guidance of CTD Quality Module.
o Discussion of the most common deficiencies in Quality module of the CTD file.
8. Electronic CTD “eCTD” Overview
Course Trainer Biography
- More than 19 years of experience in Human Pharmaceuticals Registration and Regulatory Affairs with CTD training experience.
- Diploma in RA CTD - EXTEDO GmbH – Germany.
- CTD consultant for many Egyptian companies with EDA guidelines experience.
for more info please contact us: (+2) 01093338822
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