Regulatory Affairs: Part 1: The IND Phase
Venue: Drug Information Association, Inc
Location: Horsham, Pennsylvania, United States
Event Date/Time: Sep 21, 2011 | End Date/Time: Sep 23, 2011 |
Description
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
· How to interact with FDA
· Procedures for reporting adverse events (AEs)
Event Code:
11434