The Drug Approval Process: Preparation and Processing of INDs and NDAs 2014

Topics

• Requirements for testing of new molecules
• The entire FDA Drug Approval Process
• Human clinical trials
• INDs
• FDA review of submissions
• NDAs

Who should Attend

• Quality Personnel
• Regulatory Affairs Personnel
• Legal Personnel
• Research and Development Personnel
• Clinical Personnel
• Manufacturing Personnel
• Project Managers
• Technical Personnel
• Other personnel who require an understanding of the FDA Drug Approval Process