Learn how to apply regulatory concepts to ensure compliant IND submissions to FDA. 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

· How to interact with FDA

· Procedures for reporting adverse events (AEs)


Event Code:
11434