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?