Regulatory II: The CTD/NDA Phase Training Course

Venue: Hilton Inn at Penn

Location: Philadelphia, Pennsylvania, United States

Event Date/Time: Oct 22, 2007 End Date/Time: Oct 24, 2007
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Description

This course will offer insight into the regulatory background of the NDA, outline how to prepare an NDA in CTD format, and review post-approval activities. The course will focus on drug and well-characterized biological products and not the regulatory process for devices, generic products or traditional biologics.


Course Highlights
•Overview the Roles and Responsibilities of FDA
•NDA in CTD Format
•Regulatory compliance and FDA inspections
•Post-approval regulatory requirements for NDAs
•Regulatory requirements for prescription dug labeling
•Review of prescription drug/biologics advertising and promotional labeling.

Venue

3600 Sansom St
Philadelphia
Pennsylvania
United States
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