MASTER OF SCIENCE IN GLOBAL CLINICAL AND PHARMACOVIGILANCE REGULATIONS (GCPR)

General

Program Description

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 following:

• 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.

Last updated Oct 2020

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About the School

TUSP, one of the oldest pharmacy schools in Pennsylvania, has roots that date back to 1901. Today, TUSP has grown into a dynamic, influential name in pharmacy research and education. In 2010, the Carn ... Read More

TUSP, one of the oldest pharmacy schools in Pennsylvania, has roots that date back to 1901. Today, TUSP has grown into a dynamic, influential name in pharmacy research and education. In 2010, the Carnegie Foundation for the Advancement of Teaching recognized Temple as one of only 99 public and private universities to merit an RU/H classification, indicating high research activity. Our award-winning research and faculty help shape our legacy and give our students something to celebrate and aspire to. Temple’s students, after all, are at the center of our efforts and success. Our Pharm.D., Graduate Degrees in the Pharmaceutical Sciences and Regulatory Affairs and Quality Assurance (RAQA) graduate program provide our diverse and talented student body with the opportunities they need to help them meet their various professional and educational goals. As a school, TUSP does everything possible to contribute to the solid reputation of Temple University and promote innovation and progress in the pharmaceutical sciences and pharmacy practice. Every year, TUSP graduates cultivated, informed, ethical practitioners and researchers out into the world. Last year we proudly graduated 98.6% of our Pharm.D. professional class, solidifying our graduation rate in the top third percentile of U.S. pharmacy schools. Read less