IND/CTA Preparation and Submission

Note: This will be the final offering of this course. It will be replaced by IND/CTA Preparation, Submission and Agency Interfacing PB HLTH X404.8 in Fall 2019. The new course combines this class with IND/CTA Enabling Studies and Agency Interfaces PB HLTH X402.4.

Master the role of regulatory affairs in the preparation, development, submission and approval of the IND/CTA, including the roles of project management professionals. Using case studies, examine the various components of the submission, how it is prepared using subject matter experts, how its accuracy can be assured, how it is submitted, how to respond to regulatory inquiries and the process for initiating trials.