Regulatory Affairs, MRA

The objective of the Master of Regulatory Affairs (MRA) degree program is to produce a cadre of highly trained and sophisticated practice professionals adept in the skills necessary to maximize compliance and minimize risk in the development of FDA regulated products. Students will learn both the foundation and application of science-based clinical investigation and the corresponding regulation. The program is designed to meet these objectives through didactic course work and an experiential capstone project.

Curriculum

Students must complete 10 course units and achieve a B- or higher for all course work counted toward the degree. The MRA program is a fully online program.
 
Core Requirements
BIOE 5800Research Ethics1
REG 5100Introduction to Clinical and Translational Research1
REG 6100Fundamentals of FDA Regulation1
REG 6120Introduction to Drug Development1
REG 6140Biopharmaceutical Product Development, Manufacturing and Regulatory Affairs1
Capstone
REG 6400Capstone I1
REG 6410Capstone II1
Electives
Advisor-approved electives2
Concentration Courses
Concentration requirements1
Total Course Units10

Concentrations

General 

 
General Concentration
REG 6150Post-Approval Maintenance of Drugs, Biologics, and Devices.1
Total Course Units1

Clinical Research

 
Clinical Research Concentration
REG 6110Clinical Study Management1
Total Course Units1

Quality Assurance

 
Quality Assurance Concentration
REG 6160Quality Assurance1
Total Course Units1

The degree and major requirements displayed are intended as a guide for students entering in the Fall of 2022 and later. Students should consult with their academic program regarding final certifications and requirements for graduation.