Programme overview
Main Subject
Pharmacy and Pharmacology
Degree
MSc
Study Level
Masters
Study Mode
On Campus
The Master of Science in Global Clinical and Pharmacovigilance Regulations in the School of Pharmacy at Temple University 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 regulatory affairs (RA) and quality assurance (QA) graduate program.
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 product
- 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.
Programme overview
Main Subject
Pharmacy and Pharmacology
Degree
MSc
Study Level
Masters
Study Mode
On Campus
The Master of Science in Global Clinical and Pharmacovigilance Regulations in the School of Pharmacy at Temple University 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 regulatory affairs (RA) and quality assurance (QA) graduate program.
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 product
- 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.
Admission Requirements
Scholarships
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