药学院
» Master of Science in 监管事务 (pending approval)
澳门威尼斯人app下载大学’s Master of Science 规管事务(MSRA) is a four-semester program that provides advanced didactic education 和 experiential simulation training in an online format to help professionals advance as 监管事务 experts 和 leaders.
项目特色:
- Two program tracks: Biopharmaceutical 和 医疗设备
- Part-time program options available for working professionals.
- 位于生物医学附近, biotech 和 pharmaceutical 公司 和 other job opportunities in Irvine, 加州.
- Program covers the steps required to bring a medical product to market, both in the U.S. 在全球范围内.
- Graduate courses address critical 监管 issues affecting all stages 和 processes in 监管事务.
为什么选择CUSP?
CUSP will provide students with a solid foundation in an integrated 和 interdisciplinary program within the 监管 事务 科学 和实践 相结合:
- A comprehensive education 和 training to include strong 基础知识, 当前实践 和 与…有关的伦理 监管事务.
- 领导, innovation 和 entrepreneurship in 病人 监管事务 通过教学式的课程作业、模拟 主动学习实习
- 课程 和仿真 that broadens the trainees’ background to 增强 就业机会 监管事务
- The 药学院's location in Irvine, 奥兰治县, CA, provides unique opportunities for students to network with nearby 医疗器械及医药 公司 卫生保健组织. 奥兰治县 is a hub for the 医疗器械及医药 industry, 还有医疗机构. 奥兰治县 is the 1st US county by the number of employees 和 2nd by the number of medical equipment 和 supplies manufacturing establishments (US Bureau of Labor Statistics). 有相当数量的 监管事务 positions 和 job openings in Orange, 加州 和 the US
- Ranked #121 among 399 top-tier universities in the U.S. 根据 U.S. 新闻 & 世界报道, Chapman offers students personalized educational opportunities 和 a world-class faculty.
切换部分
课程
理学硕士 规管事务(MSRA) degree requires completion of at least 30 学分. 这些包括18 学分的 核心 至少是课程 9 选修课程学分 3 论文学分 或者顶点项目.
The MSRA program has two tracks: Biopharmaceutical 和 医疗设备
A program of study is developed individually in consultation with the student's mentor 和 is designed to ensure expertise in the student’s principal field. This will present students with the 机会, under the supervision of the program 顾问, to tailor their academic program to prepare them for the career path of their 选择.
生物制药跟踪
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核心 课程(18学分) |
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美国监管框架. FDA监管途径和选择, |
3 |
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Biologic 和 Biosimilar License Applications (CDER 和 CBER): Pre-marketing Regulation |
3 |
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Biologic 和 Biosimilar License Applications (CDER 和 CBER): Advanced Therapy Medicinal Products 和 Post-Marketing Requirements |
3 |
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美国新药申请, 简易药物申请, 和 Over-the-Counter Pre-Marketing Regulations |
3 |
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Biomedical Products Marketing, Pricing 和 Reimbursement |
3 |
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US Nonclinical 和 Clinical Regulation of Biomedical Products |
3 |
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Elective Courses (minimum 9 学分) |
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小灵通634 |
全球监管事务 |
3 |
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小灵通638 |
医疗设备应用, Software 和 Digital Health Applications: Quality Assurance 和 Post-Marketing Requirements |
3 |
|
小灵通639 |
医疗设备应用, Software 和 Digital Health Applications: Pre-Marketing Regulation |
3 |
|
小灵通602 |
药物发现与开发 |
3 |
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小灵通612 |
药物作用高级原理 |
4 |
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小灵通614 |
生物制剂 |
2 |
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小灵通615 |
制药acogenomics 和 制药acogenetics |
2 |
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小灵通621 |
Introduction to 制药aceutical Manufacturing Process |
3 |
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小灵通631 |
医学诊断 |
3 |
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小灵通632 |
医疗设备 |
3 |
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小灵通651 |
Quality System for Development 和 Manufacturing Drugs |
3 |
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小灵通661 |
生物医药市场准入 |
3 |
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小灵通662 |
Economic Evaluation of Health Care Services 和 Products |
3 |
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小灵通690 |
实习 |
3 |
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小灵通701 |
研究 |
1-3 |
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小灵通702 |
研究旋转 |
1 |
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论文 or Non-论文 Option (3 学分) |
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顶石 |
3 |
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论文 |
3 |
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医疗设备 Track
|
核心 课程(18学分) |
||
|
小灵通625 |
美国监管框架. FDA监管途径和选择 |
3 |
|
小灵通634 |
全球监管事务 |
3 |
|
小灵通637 |
Biomedical Products Marketing, Pricing 和 Reimbursement |
3 |
|
小灵通638 |
医疗设备应用, Software 和 Digital Health Applications: Quality Assurance 和 Post-Marketing Requirements |
3 |
|
小灵通639 |
医疗设备应用, Software 和 Digital Health Applications: Pre-Marketing Regulation |
3 |
|
小灵通640 |
US Nonclinical 和 Clinical Regulation of Biomedical Products |
|
|
Elective Courses (minimum 9 学分) |
||
|
Biologic 和 Biosimilar License Applications (CDER 和 CBER): Pre-marketing Regulation |
3 |
|
|
Biologic 和 Biosimilar License Applications (CDER 和 CBER): Advanced Therapy Medicinal Products 和 Post-Marketing Requirements |
3 |
|
|
美国新药申请, 简易药物申请, 和 Over-the-Counter Pre-Marketing Regulations |
3 |
|
|
小灵通602 |
药物发现与开发 |
3 |
|
小灵通612 |
药物作用高级原理 |
4 |
|
小灵通614 |
生物制剂 |
2 |
|
小灵通615 |
制药acogenomics 和 制药acogenetics |
2 |
|
小灵通621 |
Introduction to 制药aceutical Manufacturing Process |
3 |
|
小灵通631 |
医学诊断 |
3 |
|
小灵通632 |
医疗设备 |
3 |
|
小灵通651 |
Quality System for Development 和 Manufacturing Drugs |
3 |
|
小灵通661 |
生物医药市场准入 |
3 |
|
小灵通662 |
Economic Evaluation of Health Care Services 和 Products |
3 |
|
小灵通690 |
实习 |
3 |
|
小灵通701 |
研究 |
1-3 |
|
小灵通702 |
研究方法 |
1 |
|
论文 or Non-论文 Option (3 学分) |
||
| 小灵通696 |
顶石 |
3 |
|
论文 |
3 |
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M.S. in 监管事务 项目学习成果
- Expresses foundational knowledge of the elements of the 监管 事务 科学s, including current research literature, policies 和 procedures, 和 methodology.
- 理解 监管事务 科学s by exploring 和 applying new 的想法 to current research.
- Effectively communicate scientific principles, 的想法, 和 research results with different audiences at an appropriate level.