Regulatory Strategy and FDA Negotiation in the Age of AI

Course Description

Formerly “Communicating and Negotiating with the FDA."

This course prepares regulatory affairs professionals to engage effectively with the U.S. Food and Drug Administration (FDA) throughout the medical device lifecycle, with a strategic focus on Q-submission planning and modernized workflows using AI-enabled regulatory tools.

Students will explore the structure, mission, and jurisdiction of the FDA, including its centers and field offices, while analyzing the societal, political, and industrial forces that shape regulatory priorities. Through lectures, case studies, and roleplaying, participants will gain practical experience in preparing for FDA inspections, formal meetings, and informal communications.

A central component of the course is the Q-submission process, taught as a proactive tool for regulatory alignment, risk mitigation, and strategic negotiation. Students will learn how to craft effective Q-submissions and leverage AI-based platforms to support regulatory intelligence, submission planning, and decision-making.

This course is designed for both emerging and experienced regulatory professionals, as well as cross-functional team members who interface with the FDA.

Topics Include

• Regulatory negotiation fundamentals
• AI-enabled regulatory intelligence and workflows
• Q-submission strategy and planning
• Preparing for FDA meetings