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

Venue: University of Southern California

Location: Irvine, California, United States

Event Date/Time: Jan 21, 2007 End Date/Time: Jan 24, 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

2300 Michelson Dr, Orange County Center
Irvine
California
United States
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