Regulatory I: The IND Phase
Venue: Chicago Marriott O\'Hare
Location: Chicago, Illinois, United States
Event Date/Time: Sep 17, 2007 | End Date/Time: Sep 19, 2007 |
Description
Course Highlights
•Overview of the drug development process
•IND process
•Quality assurance in drug development (GXPs)
•FDA's actions on the original IND and amendments
•Activities and submissions after the original IND
•Interaction with FDA
•Procedures for reporting adverse events (AEs)