Spring Intro 2023

Jenny Lamport

The purpose of module 2

To provide an OVERVIEW of the CTD for each of the Reviewers ● Modules 3, 4 and 5

– QUALITY OVERALL SUMMARY – NONCLINICAL OVERVIEW – CLINICAL OVERVIEW

The Organisation for Professionals in Regulatory Affairs

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The quality overall summary

 ‘Normally’ not more than 40 pages ● Excluding tables / graphs

 Function: ● Emphasise critical key parameters ● Justify where guidelines have not been followed ● Discuss key issues – Including those that integrate with other modules

The Organisation for Professionals in Regulatory Affairs

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