Method
Live-Online
Term
WINTER
Units
1.5 QUARTER UNITS
Cost
$750

Skills you will gain

  • FDA Communication Strategies: Develop clear, objective-driven messaging tailored to regulatory audiences.
  • Regulatory Negotiation Skills: Build persuasive communication techniques grounded in science and policy.
  • Meeting Preparation Techniques: Plan effectively for FDA meetings, inspections, and correspondence.
  • Agency Structure Knowledge: Understand the roles, mission, and divisions within the FDA.
  • Regulatory Environment Insights: Explore political, societal, and industrial factors shaping U.S. regulatory priorities.

Course Description


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.


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

Professional Credit

黑料不打烊 EXTENSION Approved by the California Board of Registered Nursing, Provider Number 13114, for 15 contact hours

Approved for 14 RAC recertification credits

Currently no classes scheduled. Would you like to be notified when a class is available?

This course applies to these programs:

Demo