Regulatory Affairs Part II: The NDA Phase

Date(s) And Time(s):
Mar 8 2010 8:30AM - Mar 10 2010 1:15PM

Drug Information Association, Inc.
800 Enterprise Rd Ste 200,
Horsham, PA 19044-3509


Basics of NDA Submission and Post-marketing Regulatory Requirements

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

Contact Information:

For detailed program information including faculty and topics, please contact:
Susan Mazak
Tel. +1-215-442-6183

If you have not received confirmation within 5 business days, please contact:
Tel. +1-215-442-6100
Fax +1-215-442-6199