This course will offer insight into the regulatory background of the IND and outline the content and data requirements for an IND submission to FDA. The course will focus on drug and well-characterized biological products and not the regulatory process for devices, generic products or traditional biologics.
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).
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).
