Regulatory Intelligence

This advanced course will cover FDA submissions, regulatory writing and documents associated with the major clinical trial milestones, responding to regulatory reviews, and writing about regulations. Students will learn the intricacies of FDA device, drug, and biologic submissions, gain knowledge and familiarity with the preparation and submission of specific FDA documents and correspondence following requirements and best practices, further understand the regulatory writing components of clinical trials from start-up to close out and begin to think about regulatory documents from a reviewer’s perspective and practice drafting responses.