This webinar will help you understand how non-IND clinical trials at non-US locations can be used successfully to support an IND/IDE or a marketing approval application. It will cover the critical product specific issues (drugs, biologics, diagnostic kits and medical devices) that need to be addressed when using non-US data for discussions with FDA.
Making All Data Count: FDA Acceptance of non-US Clinical Trials
7 June 2012, Palo Alto, United States
Introduction
Venue
2600 E. Bayshore Road, Palo Alto, 94303, United States
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ComplianceOnline
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