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:
•Overview of the Drug Development Process.
•IND Process.
•Quality assurance in drug development.
•FDA actions on the original IND and amendments.
•Activities and submissions after the original IND.
•Interactions with FDA.
•Procedures for reporting adverse drug events (AES) that occur during clinical investigations and post approval
•NDA in CTD format
•Regulatory compliance and FDA inspections
•Post-approval regulatory requirements
•Regulatory requirements for prescription product labeling, advertising and promotion.
COURSE HIGHLIGHTS:
•Overview of the Drug Development Process.
•IND Process.
•Quality assurance in drug development.
•FDA actions on the original IND and amendments.
•Activities and submissions after the original IND.
•Interactions with FDA.
•Procedures for reporting adverse drug events (AES) that occur during clinical investigations and post approval
•NDA in CTD format
•Regulatory compliance and FDA inspections
•Post-approval regulatory requirements
•Regulatory requirements for prescription product labeling, advertising and promotion.
