Master of Professional Studies in Regulatory Affairs

Curriculum

To earn the Master of Professional Studies in Regulatory Affairs, students must successfully complete 12, three-credit courses (36 credits total). This includes two core courses, Ethics and Capstone, as well as foundation and elective coursework.

Required Courses

Core Courses
MPRA 500: Ethics of Regulatory and Clinical Affairs
MPRA 900: Capstone

Foundation Courses
MPRA 600: The Regulation of Pharmaceuticals
MPRA 610: The Regulation of Medical Devices
MPRA 620: The Regulation of Biologics
MPRA 630: Food, Drug, and Cosmetic Act and Laws
MPRA 640: Principles of Good Manufacturing Practice
MPRA 650: Regulations of Human Experimentation and Good Clinical Practice

Elective Courses

MPRA 700: Regulatory Labeling and Promotional Principles of Medical Products
MPRA 710: Regulatory Submissions Practicum
MPRA 720: Strategic Planning and Project Management in Regulatory and Clinical Affairs
MPRA 730: Major International Markets in Regulatory Affairs
MPRA 740: Clinical Research Strategy and Managing of Clinical Trials
MPRA 750: Introduction to Drug Safety and Pharmacovigilance
MPRA 760: Institutional Human Research Protection Program (HRPP) Management
MPRA 770: United States Federal and State Human Research Oversight Systems
MPRA 780: Advanced Research Ethics

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