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.
 
Core Requirements
BIOE 580Research Ethics1
REG 510Introduction to Clinical and Translational Research1
REG 610Fundamentals of FDA Regulation1
REG 612Introduction to Drug Development1
REG 614Biopharmaceutical Product Development, Manufacturing and Regulatory Affairs1
Capstone
REG 640Capstone1
REG 641Capstone II1
Electives
Advisor-approved electives2
Concentration Courses
Concentration requirements1
Total Course Units10

Concentrations

General 

 
General Concentration
REG 615Post-Approval Maintenance of Drugs, Biologics, and Devices.1
Total Course Units1

Clinical Research

 
Clinical Research Concentration
REG 611Clinical Study Management1
Total Course Units1

Quality Assurance

 
Quality Assurance Concentration
REG 616Quality Assurance1
Total Course Units1

The degree and major requirements displayed are intended as a guide for students entering in the Fall of 2020 and later. Students should consult with their academic program regarding final certifications and requirements for graduation.