How to Use Foreign Trial Data in Your NDA Approval Process -- ComplianceOnline Clinical Training (Clinical Training)

Venue: Online Event

Location: Palo Alto, California, United States

Event Date/Time: Nov 17, 2010 End Date/Time: Nov 17, 2010
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In this NDA Approval Process training Webinar learn the guidance and regulations governing FDA’s acceptance of foreign trial data and know how FDA implementing these rule along with design considerations and requirements for foreign trials.

Why Should You Attend:

While the law allows 100 percent of pivotal data to come from foreign trials, there have been very few such submissions accepted by FDA – mainly in limited therapeutic areas. Given lower costs and shorter recruiting times, the use of foreign sites is appealing to all drug developers, especially generic and 505(b)(2). Due to shortcomings found during site inspections, lack of inspection resources and the general tightening of FDA safety reviews, FDA has started imposing some “unwritten” requirements for the acceptance of such data. This webinar explores these requirements and how you can ensure compliance.


Online Event
2600 E. Bayshore Road
Palo Alto
United States