Regulatory affairs professionals interact with the U.S. Food and Drug Administration (FDA) throughout the life cycle of a biomedical product. Lectures, case studies and roleplaying are used to explore the range of interactions that industry has with the FDA, including inspections and key meetings. Students learn how to prepare for these important events. This course highlights the structure, mission, jurisdiction and roles of the FDA, reviews centers within the agency, and the field offices, and examines key societal, political, industrial and biomedical drivers that impact policies, priorities, and the current U.S. regulatory environment.

This course benefits new and experienced regulatory professionals and anyone who interfaces with the FDA.

Learning Outcomes:

At the end of the course, students should be able to

• Understand the importance of effective, objective-driven communication
• Understand the role of the audience and objectives in determining the type of communication and message to be communicated
• Develop a fundamental core competency in regulatory negotiation; communicate effectively and persuasively based on the science and framework of regulations
• Understand the key elements of planning for successful meetings and correspondences

Note(s): This course was formerly titled " Interacting with the FDA "