FDA Acceptance of non-US Clinical Trials (Clinical Compliance)

Venue: Online Event

Location: Palo Alto, California, United States

Event Date/Time: Jun 07, 2012 End Date/Time: Jun 07, 2012
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Description

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.

Venue

Online Event
2600 E. Bayshore Road
Palo Alto
California
United States
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