Event:
-
Making All Data Count: FDA Acceptance of non-US Clinical
Trials
- Hosted By:
-
ComplianceOnline
- Start:
- Tuesday - Feb 12, 2013 10:00 AM
- End Time:
- Tuesday - Feb 12, 2013 11:30 AM
- Location:
- Online
- This webinar on FDA acceptance of non-US clinical trials will discuss the current FDA requirements for using clinical data from non-IND/IDE clinical trials in support of an IND and/or marketing approval application.
Why Should You Attend:
FDA acceptance criteria for non-IND/IDE clinical trials are based on internationally recognized standards of quality, ethics, and practices for human subject protection. An adequately designed non-US study can be used to greatly reduce the time of cost of getting the tested product to the US market.
If you have conducted non-IND clinical trials at non-US locations or if you would like to understand how non-IND trials can be used successfully to support an IND/IDE or a marketing approval application, this seminar is a must for you. The speaker will share his extensive experience in multi-national IND and non-IND studies to underscore the critical issues that need to be addressed when using non-US data for discussions with FDA. Case studies from drugs, biologics, diagnostic kits and medical devices will be used to highlight product specific issues with non-US clinical trials.
- Website:
-
Visit the website for detail info