Program Requirements

General Program Requirements:
Number of Credits Required Beyond the Baccalaureate: 30

Required Courses:

Core Courses
PS 8003Pharmaceutical Manufacturing I: Preformulation/Formulation3
PS 8004Solid Dosage Forms - Small Molecules3
PS 8005Pharmaceutical Biotechnology3
QARA 5468Validation of Facilities, Utilities and Equipment (FUE)3
QARA 5495Investigational New Drug/New Drug Application Submissions3
QARA 5575Regulatory Sciences: Managing the Guidelines to Quality3
QARA 5576Global CMC Issues and Regulatory Dossier (Or QARA 5577 )3
QARA 8006Physical Pharmacy I3
Pharmaceutical Sciences Elective
Select one from the following:3
PS 8002
Pharmaceutical Analysis
PS 8007
Applied Biopharmaceutics
Regulatory Affairs and Quality Assurance Elective
Select one from the following:3
QARA 5474
Process Validation
QARA 5478
High Purity Water Systems
QARA 5498
Computerized System Validation
QARA 5515
Biologics/Biosimilars: A Regulatory Overview
QARA 5572
Vaccines: Regulatory Affairs and Quality Assurance Issues
QARA 5577
Global CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics
QARA 5606
Regulatory Strategy: Discovery to Approval
Total Credit Hours30

Culminating Event: Successful completion of coursework is required to earn the MS in Pharmaceutical Regulatory Sciences.