CMC Module in Regulatory Submissions

Summary

This training examines the FDA and EMA regulatory requirements for both small and large molecules. You will get the needed confidence to identify, compile and submit the correct information in the quality module. Many examples will be shared to gain a more comprehensive understanding of areas such as CMC regulatory strategy, and the importance of a QbD approach in building the pharmaceutical sections to ensure a smooth review of the dossier.

Learning Objectives

• Gain an overview of the regulatory requirements for both small and large molecules
• Learn the structure and content of the CMC sections of a regulatory submission
• Discover how QbD can support you in preparing a regulatory submission
• Analyse real-world examples to understand practical application and challenges

Key Topics

• Understanding the Key Aspects of the CTD Global Dossier
• The Drug Substance Sections of a CTD
• The Importance of a Good Product Development Approach for the CTD
• The Drug Product CTD Sections
• How to Ensure a Smooth Review of the Dossier?

Who should attend?

• Documentation specialists
• CMC regulatory professionals
• CMC project managers
• QA/QC professionals
• Product registration personnel

Past participants

• Regulatory Affairs Manager, Pfizer
• CMC Project Manager, Britannia Pharmaceuticals
• Product Registration Manager, Ferring Pharmaceuticals

Our online training experience includes

• Our client zone – a single source for all training materials as well as pre and post-training communication
• Live interactive format via the Zoom platform
• Direct interaction with the trainer
• Q&As, case studies, polls
• Digital and LinkedIn certificates