CRED Getting the CMC Dossier Right 2024

28/08/2024

Regulatory Agency’s Perspective on the Drug Product

Section of Marketing Authorisation Applications (MAAs)

Alejandro Montón Silva

Quality Assessor

Medicines Evaluation Board, CBG-MEB (The Netherlands)

CRED Getting the CMC Dossier Right – London - September 5 th , 2024

Alejandro Montón Silva

The Organisation for Professionals in Regulatory Affairs

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Content & Learning Outcomes

● Agency’s perspectives on quality requirements for chemicals (human use) ● Potential pitfalls and practical issues experienced with the Drug product section of a MAA (3.2.P) o An agency perspective on common findings arising during regulatory review for a range of product formulations o Current experience and advice on preparation and presentation of the Drug product section of the CTD

● Quality Overall Summary – what reviewers want to see

Alejandro Montón Silva

The Organisation for Professionals in Regulatory Affairs

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