Description

This course will follow the drug/biologic development pathway and the concomitant CMC requirements by regulatory agencies. As drug development moves from concept to commercialization, the breadth and depth of CMC information required in submissions increases in parallel. It is important for manufacturers to understand the level of CMC compliance expected, so that regulatory submissions contain stage-appropriate information. The course will examine the broad range of DS (Drug Substance) and DP (Drug Product) CMC elements, and in particular, which elements are required, and in what detail, at each stage of development. FDA Guidelines and Points to Consider will be surveyed.

Instructor

Bruce K Burnett, Ph.D., RAC (US, EU), Director, Regulatory Affairs, Duke University

Course Agenda

• The Evolution of Compliance
• FDA Structure and Function
• The Product Development Timeline from IND to Commercialization
• Comparison of Small Molecule and Biologic CMCs
• The CMC Section of the Original IND
• Viral Clearance Validation for Biologics
• Working with Third Parties
• How and When to Report CMC Changes during the IND Phases
• CMC Content of the End of Phase II Meeting with FDA
• Pre-Approval Facility Inspection
• CMC Section of the Marketing Application (IND or BLA)
• The Validation Requirements of the Marketing Application
• Post-Approval CMC Commitments and Reporting