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.
