Regulatory Affairs Part I: The IND Phase and Part II: The NDA Phase

Date(s) And Time(s):
Aug 9 2010 8:30AM - Aug 13 2010 12:30PM

Omni Parker House
60 School Street
Boston, MA 02108

Interest Area(s):
Clinical Research, Regulatory Affairs


Learn how to apply regulatory concepts to ensure compliant IND submissions to the FDA. 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 of the drug development process
• The IND process
• Quality assurance in drug development (GXPs)
• FDA’s actions on the original IND and amendments
• Activities and submissions after the original IND
• Procedures for reporting adverse events (AEs)
• 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

Event Code:

Contact Information:

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