OVERCOMING COMPLEXITY IN MEETING CMC REGULATORY REQUIREMENTS FOR DRUG-LED COMBINATION PRODUCTS

Market research firms continue to forecast that the drug-led combination marketplace will continue on a path of growth and expansion, increasing the importance for pharmaceutical and biotechnology companies to have clearer understanding of regulatory requirements for combination products.

• Overview of 21 CFR 4 GMP regulations and best practices for incorporating these regulations into the quality system
• Building a design history file for the combination product, including strategies for retrospective compilation
• Outlining of global regulatory framework for combination products
• Discussion of relevant guidelines for development, registration and lifecycle management
• Best practices used to secure approval of a sustainable license

Speaker:
Suzette Roan
Associate Director, Regulatory Affairs CMC Combination Products
Biogen Inc.

Contact:

Brooke Akins | Division Director, Life Science Programs
+1 (312) 224-1693 | bakins@q1productions.com​