IND/CTA Preparation, Submission and Agency Interfacing

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 investigational new drug application and clinical trial application (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. Learn 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 to examine the various elements of IND/CTA enabling studies, learn how to negotiate with agencies to achieve success, navigate through the various components of the submission: how IND/CTA are prepared and its accuracy is assured, how it is submitted, how to respond to regulatory inquiries and how to initiate trials.