CRED Getting the CMC Dossier Right 2024

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Cover Page1
Course Programme2
Speakers6
Introduction to Preparing the Perfect Common Technical Document (CTD) Module 3 Part ‘S’10
Control of Active Drug Substances30
Data Requirements and Practical Guidance for Drug Substance Development56
Regulatory Agency’s Perspective on the Drug Substance Section (3.2.S) of Marketing Authorisation Applications70
Introduction to Preparing the Perfect Common Technical Document (CTD) Module 3 Part ‘P’92
Data Requirements and Practical Guidance for Medicinal Product Development106
Control of Medicinal Products124
Regulatory Agency’s Perspective on the Drug Product Section of Marketing Authorisation Applications (MAAs)152
Case Study Day 1172
Case Study Day 2210

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