Nicola Ambler Nov 28
Demystifying the Common Technical Document with

Demystifying the Common Technical Document

Top tips for completing the common technical document for advanced therapies with Chris Bravery, Consulting Regulatory Scientist, Advanced Biologicals

“Developers often say to me that the common technical document module three just doesn’t make any sense; it just doesn’t fit cell and gene therapy products…”

This video provides a guide to the common technical document. Chris provides a wealth of advice and real-world examples of how to (and how not to!) approach the CTD, with some distinction between cell therapies and gene therapies.

 

Chris’ top tips for demystifying the CTD are divided into four chapters, watch the video to learn more about:

  1. Applying the CTD to advanced therapies
  2. Understanding section names
  3. Batch analysis
  4. Refining your writing style

 

Watch the video to learn more...