FDA CBER Office of Cellular, Tissue and Gene Therapies (OCTGT) Online Courses

Here is where the utility of the internet begins to shine and FDA is taking advantage of what it has to offer.

The following multimedia courses are currently offered online from CBER's Office of Cellual, Tissue and Gene Therapies (OCTGT). You may submit suggestions for future courses to OCTGTLearn@fda.hhs.gov. 
    

Course List

• Introduction and Scope of OCTGT  
  Presenter: Patrick Riggins. Patrick Riggins introduces the Office of Cellular, Tissue and Gene Therapies and provides a scope of what the office does.
• IND Basics in OCTGT  
  Presenter: Patrick Riggins. This presentation looks at the basics of IND submission in OCTGT.
• Sponsor Meetings with OCTGT  
  Presenter: Lori Tull. Lori Tull describes various sponsor meetings with OCTGT.
• “361” Human Cells, Tissues, & Cellular and Tissue Based Products  
  Presenter: Samuel Barone. In this presentation, Samuel Barone describes what HCT/Ps are and how they are regulated.
• The Chemistry, Manufacturing and Controls (CMC) Section of a Gene Therapy IND  
  Presenter: Andrew Byrnes. In this presentation, Andrew Byrnes explains the basics of how to put together the CMC section of a gene therapy IND, particularly for Phase 1 trials.
• Advanced Topics: Successful Development of Quality Cell and Gene Therapy Products  
  Presenter: Denise Gavin. Denise Gavin aims to guide manufacturers toward successful development of quality cell and gene therapy products, in this presentation.
• Cellular Therapy Products  
  Presenter: Keith Wonnacott. Keith Wonnacott discusses information that is needed to prepare an investigational new drug application for a cellular therapy product.
• Preclinical Considerations for Products Regulated in OCTGT  
  Presenter: Allen Wensky. Allen Wensky provides a basic overview of preclinical considerations that make up one of the three key elements of an IND submission.