BIOE 689R: Introduction to Regulatory Affairs: Devices and Drugs (3
credits)

Course Description: This course provides an introduction to regulatory
affairs as related to US FDA regulation of devices and drugs. It covers a
summary of the FDA procedures necessary to obtain FDA approval of devices
and drugs. It covers a summary of ethical and legal issues related to
regulatory affairs. It touches on the relationship between regulatory
affairs and science and engineering, highlighting the opportunities for
technical input to the regulatory process.

Course Leader: K.E. Herold, 301-405-5268, Room 3236 Jeong H. Kim
Engineering Bldg., [log in to unmask]
Course Instructors: Guest lecturers from the FDA community
Time/Location: Lecture Thursdays, 4:00-6:30 PM, Room 2116 Chemical and
Nuclear Engineering Bldg., University of Maryland College Park Campus
Format: 2.5 hours of lecture each week, 14.5-week semester
Target Audience: Bioscience professionals looking to enhance their careers
This course is the first course in a planned Professional Master program
in Regulatory Science and Engineering. However, we also see relevance to
our student population who may work in industries regulated by the FDA.
This course is designed to provide students with a strong basis for
understanding industry interactions with the FDA. Although you sometimes
hear groans of frustration from industries that must interact regularly
with the FDA, you also hear much praise for the safety of our medical
systems compared to much of the rest of the world. If we want to maintain
that safety record, the first step is to study the FDA and understand how
and why they make their rulings. This course provides an overview of the
FDA world.

Specifics

Overview of the FDA organization and portfolio
Focus on Center for Devices and Radiological Health (CDRH)
Focus on Center for Drug Evaluation and Research (CDER)
Review of Case Studies developed by FDA
Taught by FDA experts