Regulatory Affairs Part II: The NDA Phase

Venue: Drug Information Association, Inc.

Location: Horsham, Pennsylvania, United States

Event Date/Time: Mar 08, 2010 End Date/Time: Mar 10, 2010
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Description

Gain insight into the regulatory background of the NDA, preparing an NDA, and postapproval activities. The course focuses on drug and well characterized biological products and not the regulatory process for devices, generic products, or traditional biologics.

What you will learn
• Overview and roles and responsibilities of FDA
• NDA in CTD format
• Regulatory compliance and FDA inspections
• Post-approval regulatory requirements for NDAs
• Regulatory requirements for prescription drug/biologics labeling
• Regulatory requirements for prescription drug/biologics advertising
• How to interact with the FDA

Venue