Program Requirements
General Program Requirements:
Number of Credits Required Beyond the Baccalaureate:Ìý30
Required Courses:
| Code | Title | Credit Hours |
|---|---|---|
| Core Courses | ||
| ±Ê³§Ìý8003 | Pharmaceutical Manufacturing I: Preformulation/Formulation | 3 |
| ±Ê³§Ìý8004 | Solid Dosage Forms - Small Molecules | 3 |
| ±Ê³§Ìý8005 | Pharmaceutical Biotechnology | 3 |
| ²Ï´¡¸é´¡Ìý5468 | Validation of Facilities, Utilities and Equipment (FUE) | 3 |
| ²Ï´¡¸é´¡Ìý5495 | Investigational New Drug/New Drug Application Submissions | 3 |
| ²Ï´¡¸é´¡Ìý5575 | Regulatory Sciences: Managing the Guidelines to Quality | 3 |
| ²Ï´¡¸é´¡Ìý5576 | Global CMC Issues and Regulatory Dossier (Or ²Ï´¡¸é´¡Ìý5577 ) | 3 |
| ²Ï´¡¸é´¡Ìý8006 | Physical Pharmacy I | 3 |
| Pharmaceutical Sciences Elective | ||
| Select one from the following: | 3 | |
±Ê³§Ìý8002 | Pharmaceutical Analysis | |
±Ê³§Ìý8007 | Applied Biopharmaceutics | |
| Regulatory Affairs and Quality Assurance Elective | ||
| Select one from the following: | 3 | |
²Ï´¡¸é´¡Ìý5474 | Process Validation | |
²Ï´¡¸é´¡Ìý5478 | High Purity Water Systems | |
²Ï´¡¸é´¡Ìý5498 | Computerized System Validation | |
²Ï´¡¸é´¡Ìý5515 | Biologics/Biosimilars: A Regulatory Overview | |
²Ï´¡¸é´¡Ìý5572 | Vaccines: Regulatory Affairs and Quality Assurance Issues | |
²Ï´¡¸é´¡Ìý5577 | Global CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics | |
²Ï´¡¸é´¡Ìý5606 | Regulatory Strategy: Discovery to Approval | |
| Total Credit Hours | 30 | |
Culminating Event: Successful completion of coursework is required to earn the MS in Pharmaceutical Regulatory Sciences.