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Practical Guide to INDs/IDEs - Digital Recording (July 31, 2013)

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Description
ISCT Webinar: Practical Guide to INDs/IDEs
Presented by the ISCT North American Legal and Regulatory Affairs Committee
 
Date: July 31st, 2013
 
Time: 9:00 AM Pacific, 11:00 AM Central, 12:00 PM Eastern, 6:00 PM CET (Europe)
 
Chair: Bill Janssen, PhD, Director, Cell Therapies Facility, H. Lee Moffitt Cancer Center, Tampa, FL, USA
 
Speaker(s): Bill Janssen and Amy D. Childress, J.D., M.H.A., Manager, Institutional Office of Regulatory Affairs, H. Lee Moffitt Cancer Center, Tampa, FL, USA
 
 

About the Webinar:

  • What is an IND and what do you need one for?
    • What is the difference between and IND and an IDE
    • What does it mean to cross-reference someone else’s IND?
  • What preparation do I need to do before submitting an IND?
    • What is a pre-IND meeting for, and do I need to have one?
  • What are the elements of an IND?
  • Who should I involve in putting together my IND?
  • How do I complete forms 1571 and 1572?
  • How does the review and approval process work?
  • Now I have an approved IND, what am I responsible for?
    • There has been an adverse event on my IND covered study, what am I supposed to do?
    • What goes into my annual report?
  • We have done everything that we are going to do with this IND, can I close it, and how?

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