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Overcoming Complexity in Meeting CMC Regulatory Requirements for Drug-Led Combination Products

Our Price: $395.00

Product Code: WB-7232

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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

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

Nicholas Wong
Staff Associate, Corporate Device Quality Systems
Biogen Inc.

Participants that will find this webinar most beneficial will be those involved in pharmaceutical and biotechnology companies. Job titles of attendees that will be most applicable for this session will be:

  • Regulatory Affairs CMC
  • Global Regulatory Affairs CMC
  • Regulatory Affairs

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