Coronavirus (COVID-19) Update
Fall classes are offered remotely—either live-online with an instructor, entirely self-paced, or in a blended online format. Please check our coronavirus update page for our latest announcements.
Interacting with the FDA
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 "
Sections Open for Enrollment:
|Date:||Start Time:||End Time:||Meeting Type:||Location:|
|Tue, 09-29-2020||6:00 p.m.||9:00 p.m.||Live-Online||ONLINE|
|Tue, 10-06-2020||6:00 p.m.||9:00 p.m.||Live-Online||ONLINE|
|Tue, 10-13-2020||6:00 p.m.||9:00 p.m.||Live-Online||ONLINE|
|Tue, 10-20-2020||6:00 p.m.||9:00 p.m.||Live-Online||ONLINE|
|Tue, 10-27-2020||6:00 p.m.||9:00 p.m.||Live-Online||ONLINE|
Ask us any questions you may have about this course.