This course combines the two three-day courses into one extended four-day offering. It describes the regulatory background of the IND and NDA and provides an overview of the requirements and recommendations for preparing and managing these applications.
COURSE HIGHLIGHTS
鈥verview Of The Drug Development Process
鈥ND Process
鈥uality assurance in drug development
鈥DA actions on the original IND and amendments
鈥ctivities and submissions after the original IND
鈥nteractions with FDA
鈥rocedures for reporting adverse drug events (AES) that occur during clinical investigations and post approval
鈥DA in CTD format
鈥egulatory compliance and FDA inspections
鈥ost-approval regulatory requirements
鈥egulatory requirements for prescription product labeling, advertising and promotion.
COURSE HIGHLIGHTS
鈥verview Of The Drug Development Process
鈥ND Process
鈥uality assurance in drug development
鈥DA actions on the original IND and amendments
鈥ctivities and submissions after the original IND
鈥nteractions with FDA
鈥rocedures for reporting adverse drug events (AES) that occur during clinical investigations and post approval
鈥DA in CTD format
鈥egulatory compliance and FDA inspections
鈥ost-approval regulatory requirements
鈥egulatory requirements for prescription product labeling, advertising and promotion.
