Curriculum for the MS in Global Clinical and Pharmacovigilance Regulations (GCPR)
Degree Requirements
To receive the MS in GCPR, students must successfully complete 30 credits (10 courses) with an overall B (3.0) grade point average.
Required Courses
- Drug Development (5459)
- Good Clinical Practices (5536)
- Clinical Trial Management (5537)
- Clinical Drug Safety and Pharmacovigilance (5538) OR Post-Marketing Safety Surveillance (5571)
- Good Pharmacovigilance Operations (5508)
- Regulatory and Legal Basis of Pharmacovigilance (5579)
- Benefit-Risk Management and Safety Signaling of Healthcare Products (5578)
- Pharmacoepidemiology (5573)
Two Electives From
- Global Clinical Drug Development (5539)
- Bioethics for Pharmaceutical Professionals (5612)
- Clinical Data Management (5618) (strongly recommended)
- Clinical Trial Project Management (5547)
- Risk Management of Pharmaceutical and Medical Devices (5548)
- Statistics for Clinical Trials (5497)
Transfer Credits
PharmD students in Temple University School of Pharmacy may bring a maximum of 15 credits into the MS in GCPR, provided a grade of B or higher were earned in those courses specified by the School.
Candidates who do not hold a PharmD from Temple University School of Pharmacy may bring in a maximum of 6 credits (2 courses) in the following areas, provided a grade of B or higher was earned at an accredited pharmacy school:
- adverse drug reactions
- pharmacokinetics
- drug development
- good clinical practices
Requests for transfer credits must be made before the student starts any courses in the MS in GCPR degree. Retroactive requests for transfer credits will not be accepted. All requests for transfer credits must include copies of syllabi from the school where the courses were completed.