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When FDA Inspections Intersect IND/IDE Research: How to Prepare and What to Expect

Responsible Conduct of Research Seminar Series: This webinar will provide an overview about the latest FDA compliance rules, featuring Dr. Harvey Arbit, and brought to you by the UofL Research Integrity Program, Office of Industry Contracts and the Human Subjects Protection Program. All attendees will receive 1.5 contact hours of Responsible Conduct of Research training. Attendance is limited to 35. RSVP to ori@louisville.edu or call 852-1637.

What
When Nov 11, 2010
from 01:00 pm to 02:30 pm
Where IRB Conference room (Room 230 in Suite 200), Med Center One, 501 E. Broadway
Contact Name Elizabeth Langston
Contact Phone 852-2454
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Detail provided by Principal Investigators Association:

When FDA Inspections Intersect IND/IDE Research:  How to Prepare and What to Expect

 

This webinar will be held on Thursday November 11, 2010, from 1:00- 2:30 PM ET in the IRB Conference Room- Med Center One, Suite 200.  Attendance is limited to 35.  RSVP to Research Integrity or call 852-1637.

The last thing you want is to receive is a warning from the FDA – or much worse have your research disqualified and your funding terminated!

Join clinical research expert, Dr. Harvey Arbit, as he runs down the what, when and how of regulatory obligations in IND/IDE and what you need to do before, during and after an FDA inspection.

CONFERENCE TAKE-AWAYS:

  •  Summary of your actual responsibilities as a PI and/or Sponsor PI
  • Step-by-step approach to handling an FDA inspection
  • Insider information on FDA "hot buttons" and how to avoid them
  • Knowledge of the tools the FDA has to bring you to compliance
  • BONUS!  Examples of real FDA warning letters.

Your career as a clinical researcher is built on ethics and integrity. Don’t allow your reputation to be compromised. Dr. Arbit will guide you through the FDA’s current thinking to prepare you for success!

 

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