IND/CTA Enabling Studies and Agency Interfaces

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 Preparation and Submission PB HLTH X402.3.

Regulatory affairs plays an important role during the first stages of product development in ensuring that all appropriate studies are performed to prepare and submit the IND/CTA. Understand this role, and master the initial steps that regulatory affairs professionals take in the product development life cycle, including the responsibilities as facilitators and conduits between companies and regulatory agencies. Using case studies, understand the various elements of IND/CTA enabling studies and how to negotiate with agencies to achieve success.