Regulatory Affairs and Quality Assurance Graduate Program of Temple University School of Pharmacy
Master of Science in Global Clilnical and Pharmacovigilance Regulations (GCPR)
(PharmD or MD degree required)
The MS in Global Clinical and Pharmacovigilance Regulations focuses on both disciplines of clinical trials and pharmacovigilance, enabling PharmD graduates to pursue positions as clinical trial project managers, research administrators, safety managers and safety directors in the global marketplace. The curriculum provides the skills needed to manage and oversee clinical trials, supervise record keeping, review clinical trial or post marketing safety data, and interpret results.
After completing this degree, students will understand the
• need for pharmacovigilance and clinical regulations;
• evolution of pharmacovigilance and clinical regulations;
• domestic and international pharmacovigilance and clinical requirements and regulations for healthcare products;
• differences in regulations between product types and regions;
• pharmacovigilance data throughout product lifecycle;
• ability to contextualize and interpret safety data;
• pharmacovigilance and clinical terminology and key stakeholders;
• clinical trial and pharmacovigilance quality management systems and preparation for inspections;
• key concepts and rationale for Benefit-Risk Assessments of healthcare products throughout their lifecycles;
• importance that data collection, statistics, and data mining have in the industry.
Students may pursue this program on a part-time basis, since courses are offered evenings and weekends both on-campus and online.
To receive the MS in GCPR, students must successfully complete 30 credits (10 courses) with an overall B (3.0) grade point average.
- 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)
(Upon successful completion of the degree, GCPR recipients may also apply for a certificate in Global Pharmacovigilance: Benefit-Risk Assessment)
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
- 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.
How to Apply
Applicants for the MS in Global Clinical and Pharmacovigilance Regulations must have an MD degree or a PharmD from an ACPE-accredited School.
Please follow the same application procedures that are used for the MS in RAQA. Deadlines for applying to the MS in GCPR are identical to the MS in RAQA.
Students may start or finish the MS in GCPR during any semester (Fall, Spring, or Summer).
All courses in the MS in GCPR are available entirely online. Courses are also offered on-campus at the RAQA site in Fort Washington, PA.
Questions? Write to QARA@temple.edu.
OR, MAIL YOUR REGISTRATION TO:
QA/RA Graduate Program
425 Commerce Drive, Suite 175
Ft. Washington, PA 19034
Is this your first registration with Temple? If so, you must fax a RESIDENCY FORM
Will this be your fourth course in the QA/RA program? If so, you must fax a Non-Matriculated Graduate Student Waiver
to receive updates on schedule postings!
Email us at the link listed above. Make sure you include your site location!
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