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
Associate Director, Regulatory Affairs CMC Combination Products