$249 USD

Preparing Submissions in the Common Technical Document Format

Learn how to prepare the Common Technical Document for marketing authorization applications

  • English
  • Certificate of completion
  • 2 Hours
  • Regulatory / Quality Assurance
  • 1 Year

Overview

The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) designed the Common Technical Document (CTD) as a global standard/common format for submitting applications for marketing authorization in participating regions. Gain an understanding of what the CTD is, its advantages and limitations, and an explanation of the structure of the CTD.

Regulatory affairs and compliance staff, and all those involved in drug development and who contribute to regulatory submissions, will find the module an invaluable introductory training course and/or a useful reference tool. Specialists in data handling, knowledge management or documentation will also wish to familiarise themselves with its contents.

This course will cover:

  • Introduction – Introduction to the nature of the Common Technical Document (CTD), a global standard designed by the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use). The composition of a regulatory submission team is outlined.
  • High-level structure – Become more familiar with the five modules of the CTD.
  • Fine structure and format – Get access to guidelines that specify in detail the structure of each module of the CTD and the relationship between their sections and the documents that make up a dossier. Recommendations are also given on how to segregate and paginate documents and how to format pages, tables of contents, and cross-references.
  • Using the CTD – Different ways in which you can use the CTD in practice are described.

Learn:

  • To define the Common Technical Document (CTD)
  • The format (overall structure/outline) and how to prepare the document
  • Where CTD is commonly used
  • To understand its limitations and advantages
Read full overview

Agenda

1. Section 1: Introduction

2. Section 2: High-Level Structure

3. Section 3: Fine Structure and Format

4. Section 4: Using the CTD

5. Section 5: Assessment

To top