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 601Introduction to Clinical Bioethics
REG 510Introduction to Clinical and Translational Research1
REG 610Fundamentals of FDA Regulation1
REG 611Clinical Study Management
REG 612Introduction to Drug Development1.0
REG 613 (or REG 614)
Capstone
REG 640Capstone1
Electives
Advisor-approved electives
Concentration Courses
Concentration requirements5

Concentrations

General 

 
Core
BIOE 580Research Ethics
REG 510Introduction to Clinical and Translational Research
REG 610Fundamentals of FDA Regulation
REG 612Introduction to Drug Development
REG 614Biopharmaceutical Product Development, Manufacturing and Regulatory Affairs
Electives
Advisor-approved electives 500-level and above
Capstone
REG 640Capstone
REG 641Capstone II

Clinical Research

 
Core Courses
BIOE 580Research Ethics
REG 510Introduction to Clinical and Translational Research
REG 610Fundamentals of FDA Regulation
Supplemental Core
REG 611Clinical Study Management
REG 612Introduction to Drug Development
REG 614Biopharmaceutical Product Development, Manufacturing and Regulatory Affairs
Electives
Advisor-approved electives 500-level and above
Capstone
REG 640Capstone
REG 641Capstone II

Quality Assurance

 
Core
BIOE 580Research Ethics
REG 510Introduction to Clinical and Translational Research
REG 610Fundamentals of FDA Regulation
Supplemental Core
REG 612Introduction to Drug Development
REG 614Biopharmaceutical Product Development, Manufacturing and Regulatory Affairs
REG 616Quality Assurance
Electives
Advisor-approved electives 500-level and above
Capstone
REG 640Capstone
REG 641Capstone II

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.