CRED Getting the CMC Dossier Right 2024

29/08/2024

CRED: Getting the CMC Dossier Right

Regulatory Agency’s Perspective on the Drug Substance Section (3.2.S) of Marketing Authorisation Applications

Dr Bassel Odeh Head of New Active Substances – Innovative Medicines Leading Senior Pharmaceutical Assessor, MHRA September 2024

ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION

The Organisation for Professionals in Regulatory Affairs

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Learning Outcomes

⚫ Potential pitfalls and practical issues with the active drug substance section of an MAA

⚫ An agency perspective on common findings arising during regulatory review

⚫ Current experience and advice on preparation of the drug substance section of the CTD

⚫ Quality Overall Summary (QOS) – What reviewers want to see

⚫ Falsified Medicines Legislation (FMD)

⚫ Inspection issues for drug substance manufacturers

The Organisation for Professionals in Regulatory Affairs

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