Enroll Now for Spring Discount15% discount on select spring courses for all subscribers.
Coronavirus (COVID-19) Update
Our courses are taught remotely through spring 2021. Please check our coronavirus update page for our latest announcements.
Interacting with the FDA | REGL.X402
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 "
Course Availability Notification
Please use this form to be notified when this course is open for enrollment.