Spring Intro 2023

Jenny Lamport

CTD structure of the MA submission…

Module 1 – Administrative data + Regional information

1.0

2.2 Introduction TOC

Module 2: Summaries

2.4 Overview

2.7 Summary 2.5 Overview

2.3 QOS 2.6

Summary

Modules 3,4,5: Quality Nonclinical Clinical

3 Quality

4 Non clinical

5 Clinical

The Organisation for Professionals in Regulatory Affairs

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Format of the CTD

….designed to accommodate e-submissions ● Modular structure – Self-contained pieces of data ● Logical hierarchy of information ● Simple numbering system

……….ONE SIZE FITS ALL

The Organisation for Professionals in Regulatory Affairs

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