CRED Getting the CMC Dossier Right 2024

28/08/2024

Quality Overall Summary

Alejandro Montón Silva

The Organisation for Professionals in Regulatory Affairs

35

The role of QOS

● It is a summary that follows the scope and the outline of the Body of Data in Module 3 ● Should not include information, data or justification that was not already included in Module 3

● Key issues should be emphasized

● Mostly only summary of dossier, no critical approach

● Where responses also contain new or updated data related to Module 3, such information should be placed in the relevant sections of Module 2 before the end of the MAA procedure.

Alejandro Montón Silva

The Organisation for Professionals in Regulatory Affairs

36