Master of Science in Global Clinical and Pharmacovigilance Regulations (GCPR)
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.
To receive the MS in GCPR, students must successfully complete 30 credits (10 courses) with an overall B (3.0) grade point average.
(Upon successful completion of the degree, GCPR recipients may also apply for a certificate in Global Pharmacovigilance: Benefit-Risk Assessment)
(The MS in Global Clinical and Pharmacovigilance Regulations is available entirely online)