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

PRODUCT INFO

Includes 1 Hour Windows Media Video File and PowerPoint presentations for immediate download.

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.

Brooke AkinsContact:

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