Global Clinical 和 Pharmacovigilance Regulations Master of Science

的 Master of Science in Global Clinical 和 Pharmacovigilance Regulations 在 药学院 at 威尼斯赌场网站 focuses on both disciplines of clinical trials 和 pharmacovigilance, enabling PharmD 和 MD graduates to pursue positions in U.S. 以及全球临床试验项目, research administrators 和 safety directors 在 global marketplace. 这个硕士课程是学校的一部分 regulatory affairs (RA) 和 quality assurance (QA) graduate program.

的 curriculum provides the skills needed to manage 和 oversee clinical trials, 监督记录, review clinical trial or post marketing safety data, 并解释结果. After completing this degree, students will underst和 the following. 

• Need for pharmacovigilance 和 clinical regulations 

• Evolution of pharmacovigilance 和 clinical regulations 

• Domestic 和 international pharmacovigilance 和 clinical requirements 和 regulations for healthcare products

• Differences in regulations between product types 和 regions

• Pharmacovigilance data throughout product lifecycle

• Ability to contextualize 和 interpret safety data

• Pharmacovigilance 和 clinical terminology 和 key stakeholders

• Clinical trial 和 pharmacovigilance quality management systems 和 preparation for inspections

• Key concepts 和 rationale for benefit-risk assessments of healthcare products throughout their lifecycles 

• Importance that data collection, statistics 和 data mining have 在 industry 

Students may pursue this program on a part-time basis, since courses are offered evenings 和 weekends both 校园 和 online. 

Regulatory Affairs 和 Quality Assurance at the 药学院

的 first university to develop a graduate program in quality assurance 和 regulatory affairs, the 威尼斯赌场网站 药学院 continues to set the gold st和ard in this dynamic professional discipline. 自1968年以来, the school has remained 在 forefront of industry education, offering more courses in RA 和 QA than any other similar graduate program. Each year we continue to add 和 refine the curriculum to incorporate the latest trends in 管理科学s. 

RA 和 QA courses expose students to real-world developments 在 pharmaceutical industry, from current quality practices to the latest trends in domestic 和 global regulation. 在整个学习过程中, RA 和 QA students gain a greater appreciation for benefit-risk assessment, 监管情报, 数据挖掘和统计相关性, 和 the complexities of blending pharmaceutical 和 管理科学 on a global scale. 

大多数学生在工业界工作, representing the world’s foremost pharmaceutical, 设备和生物技术公司. 的ir experience 和 knowledge vary considerably: Some are just starting their careers, while others have been involved in industry for 30 years or more.  

With students 和 faculty drawn from more than 300 companies, 社交机会是巨大的. Each classroom experience coalesces the experiences of individuals from multiple aspects of the industry, 包括质量保证和控制, 管理科学, R&D, 制造和验证, 临床研究和试验, 医疗事务和药物警戒, 生物技术和仿制药, 医疗设备和组合产品, 市场营销和销售.  

来自化妆品的学生, 化学, healthcare 和 food industries also participate to gain a deeper underst和ing of quality practices 和 regulatory compliance.

程序的格式 & 课程

学生完成以下必修课程. 

• 药物开发(5459) 

• 良好临床规范(5536) 

• 临床试验管理(5537)

• Clinical Drug 安全 和 Pharmacovigilance (5538) or 上市后安全监察(5571)

• 良好的药物警戒操作(5508)

• Regulatory 和 Legal Basis of Pharmacovigilance (5579)

• Benefit-Risk Management 和 安全 Signaling of Healthcare Products (5578)

• 学部(5573) 

Students also choose two elective courses from the following options. 

• 全球临床药物开发(5539) 

• Bioethics for Pharmaceutical 专业s (5612) 

• 临床数据管理(5618) (强烈推荐) 

• 临床试验统计(5497) 

Learn more about the Global Clinical 和 Pharmacovigilance Regulations MS.

参见课程设置 和 查看日程安排.   

需求 

Students must hold a PharmD or MD to pursue this degree. To receive the MS in Global Clinical 和 Pharmacovigilance Regulations, students must successfully complete 30 credits (10 courses) with an overall B (3.平均绩点.