51¶¯Âþ

Global Clinical and Pharmacovigilance Regulations Master of Science

The Master of Science in Global Clinical and Pharmacovigilance Regulations in the at 51¶¯Âþ focuses on both disciplines of clinical trials and pharmacovigilance, enabling PharmD and MD graduates to pursue positions in U.S. and global clinicals trial projects, research administrators and safety directors in the global marketplace. This master’s program is part of the school’s .

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. 

Regulatory Affairs and Quality Assurance at the School of Pharmacy

The first university to develop a graduate program in quality assurance and regulatory affairs, the 51¶¯Âþ School of Pharmacy continues to set the gold standard in this dynamic professional discipline. Since 1968, the school has remained in the forefront of industry education, offering more courses in RA and QA than any other similar graduate program. Each year we continue to add and refine the curriculum to incorporate the latest trends in regulatory sciences. 

RA and QA courses expose students to real-world developments in the pharmaceutical industry, from current quality practices to the latest trends in domestic and global regulation. Throughout their course of study, RA and QA students gain a greater appreciation for benefit-risk assessment, regulatory intelligence, data mining and statistical relevance, and the complexities of blending pharmaceutical and regulatory science on a global scale. 

Most students work in industry, representing the world’s foremost pharmaceutical, device and biotechnology companies. Their experience and knowledge vary considerably: Some are just starting their careers, while others have been involved in industry for 30 years or more.  

With students and faculty drawn from more than 300 companies, the networking opportunities are tremendous. Each classroom experience coalesces the experiences of individuals from multiple aspects of the industry, including quality assurance and control, regulatory science, R&D, manufacturing and validation, clinical research and trials, medical affairs and pharmacovigilance, biotechnology and generic drugs, medical devices and combination products, and marketing and sales.  

Students from the cosmetic, chemical, healthcare and food industries also participate to gain a deeper understanding of quality practices and regulatory compliance.

Program Format & Curriculum

Students complete the following 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) 

Students also choose two elective courses from the following options. 

• Global Clinical Drug Development (5539) 

• Bioethics for Pharmaceutical Professionals (5612) 

• Clinical Data Management (5618) (strongly recommended) 

• Statistics for Clinical Trials (5497) 

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Students must hold a PharmD or MD to pursue this degree. To receive the MS in Global Clinical and Pharmacovigilance Regulations, students must successfully complete 30 credits (10 courses) with an overall B (3.0) grade point average.