This course combines the two three-day courses into one extended five-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.
Please note that this August offering is a 5 day version of Regulatory Affairs: Part I: The IND Phase and Part II: The CTD/NDA Phase.
Please note that this August offering is a 5 day version of Regulatory Affairs: Part I: The IND Phase and Part II: The CTD/NDA Phase.