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

Venue: Park Hyatt Philadelphia at the Bellevue

Location: Philadelphia, Pennsylvania, United States

Event Date/Time: Nov 05, 2007 End Date/Time: Nov 05, 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.
•Postapproval and marketing Regulatory requirements and processes.
•Overview of the CTD format.

Venue

Broad and Walnut Streets
Philadelphia
Pennsylvania
United States
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