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
鈥verview of the drug development process
鈥ND process
鈥uality assurance in drug development (GXPs)
鈥DA's actions on the original IND and amendments
鈥ctivities and submissions after the original IND
鈥nteraction with FDA
鈥rocedures for reporting adverse events (AEs).
COURSE HIGHLIGHTS
鈥verview of the drug development process
鈥ND process
鈥uality assurance in drug development (GXPs)
鈥DA's actions on the original IND and amendments
鈥ctivities and submissions after the original IND
鈥nteraction with FDA
鈥rocedures for reporting adverse events (AEs).
