Regulatory Affairs: Part I: The IND Phase & Part II: The CTD/NDA Phase

Venue: West Chester University

Location: West Chester, Pennsylvania, United States

Event Date/Time: Apr 23, 2007 End Date/Time: Apr 26, 2007
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Description

This is a modified version of two three-day courses combined into one extended four-day course. This course describes the regulatory background of the IND and NDA, and an overview of requirements and recommendations for preparing these applications for submission to the FDA.

KEY TOPICS
•Overview of FDA.
•Regulatory requirements for drug development and approval.
•Post approval and marketing regulatory requirements and processes.
•Overview of the CTD format.

Venue

Business Technology Center, WCU Graduate Business Center, 1160 McDermott Dr
West Chester
Pennsylvania
United States
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