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

Venue: Massachusetts College of Pharmacy

Location: Boston, Massachusetts, United States

Event Date/Time: Aug 07, 2006 End Date/Time: Aug 10, 2006
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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

179 Longwood Ave
Boston
Massachusetts
United States
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