CRED Getting the CMC Dossier Right 2024

28/08/2024

Introduction to Preparing the “perfect” Common

Technical Document (CTD) Module 3 - Part 'P'

Christian Monnerjahn, Regulatory Affairs Manager

Eckert & Ziegler Radiopharma GmbH

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals i Regulatory Affairs

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Topics

• Overview of Module 3.2.P structure CTD and key guidelines for content

• Data expectations and considerations for presenting CMC information in the sections of 3.2.P

Due diligence tips

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• Approaching the Quality Overall Summary (module 2.3)

The Organisation for Professionals in Regulatory Affairs

CRED: Getting the CMC dossier right – module 3.2.P

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