Program Requirements
General Program Requirements:
Number of Credits Required Beyond the Baccalaureate: 36, of which 21 are completed at Temple University's School of Pharmacy and 15 at Thomas Jefferson University's Jefferson Institute for Bioprocessing (JIB)
Required Courses:
| Code | Title | Credit Hours |
|---|---|---|
| Core Courses | ||
| QARA 5459 | Drug Development | 3 |
| QARA 5515 | Biologics/Biosimilars: A Regulatory Overview | 3 |
| QARA 5572 | Vaccines: Regulatory Affairs and Quality Assurance Issues | 3 |
| QARA 5577 | Global CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics | 3 |
| Electives | ||
| Select three from the following: | 9 | |
PS 5501 | Development of Sterile Products | |
PS 8005 | Pharmaceutical Biotechnology | |
QARA 5451 | Statistical Quality Control | |
QARA 5468 | Validation of Facilities, Utilities and Equipment (FUE) | |
QARA 5471 | Biotechnology: Bioprocess Basics | |
QARA 5474 | Process Validation | |
QARA 5479 | Advanced Good Manufacturing Practices - Defining "c" | |
QARA 5492 | Production of Sterile Parenterals | |
QARA 5493 | Sterilization Processes | |
QARA 5512 | Microbiological Concepts in Pharmaceutical Manufacturing | |
QARA 5514 | Regulatory eSubmissions | |
QARA 5516 | Cleaning Validation | |
QARA 5538 | Clinical Drug Safety and Pharmacovigilance 1 | |
QARA 5544 | Regulatory Intelligence | |
QARA 5571 | Post-Marketing Safety Surveillance 1 | |
QARA 5574 | Pharmaceutical Quality Management Systems | |
QARA 5575 | Regulatory Sciences: Managing the Guidelines to Quality | |
QARA 5625 | Process Analytical Technology (PAT) | |
QARA 5627 | Statistical Design of Experiments (DOE) | |
QARA 5629 | Process Monitoring | |
| JIB Required Courses 2 | 12 | |
| JIB Elective(s) 3 | 3 | |
| Total Credit Hours | 36 | |
- 1
Students may take QARA 5538 or QARA 5571, but not both.
- 2
Four 3-credit courses required by JIB include ENGR 604 Biopharm Process Operations, ENGR 609 Bioprocess Engineering for Scientists, ENGR 611 Principles of Biopharmaceutical Process Engineering, and ENGR 621 Introduction to Biopharmaceutical and Biologics Production. Coursework is subject to change to reflect the most current trends and techniques in the production of biopharmaceutical therapeutic agents.
- 3
Electives approved by JIB include four 3-credit courses: ENGR 601 Intro Upstream Unit Operations, ENGR 602 Intro Downstream Unit Operations, ENGR 613 Vector and Cell Line Design, and ENGR 622 Biotherapeutic Formulation. Three 1.5-credit courses are also approved: ENGR 612 Emerging Therapeutics; ENGR 614 Vaccine Formulation; and ENGR 618 Technical and Regulatory Aspects of Analytical Method Validation. Coursework is subject to change to reflect the most current trends and techniques in the production of biopharmaceutical therapeutic agents.
Culminating Event: Successful completion of coursework is required to earn Temple’s ABMRA MS.