制药监管科学理学硕士

的 制药监管科学理学硕士 在 药学院 at 亿德体育 addresses the immediate need for professionals well versed in 管理科学. 的 curriculum offers courses from pharmaceutical science and 监管事务 (RA) and quality assurance (QA), bridging the gaps in knowledge that often exist between these areas. 这个硕士学位是 RA和QA研究生课程.

的 Food and Drug Administration (FDA) defines 管理科学 as the “science of developing new tools, 安全评估的标准和方法, 功效, fda相关产品的质量和性能.” Both regulated industry and regulatory agencies need professionals who understand the complex integration of regulations, quality practices and scientific knowledge required to bring regulated healthcare products to market. 

Pharmaceutical science courses focus on the core science principles involved 在 development and 制造业 of therapeutic products. RA and QA courses provide a strong framework of regulations and quality practices, 解决确保安全所需的科学方法, 功效, 质量和一致的表现. 

课程设置借鉴了该校享誉世界的课程 RA和QA硕士课程. 课程 are taught by pharmaceutical scientists actively engaged in research as well as industry experts currently working in research and development, 药物开发, 监管事务, 制造业, 和验证. 

Individuals pursuing this graduate program must have strong science backgrounds, which include an undergraduate or graduate degree 在 hard sciences. 

Regulatory Affairs and Quality Assurance at the 药学院 

的 first university to develop a graduate program in quality assurance and 监管事务, Temple’s 药学院 continues to set the gold standard in this dynamic professional discipline. 自1968年以来, the school has remained 在 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 管理科学s.  

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

大多数学生在工业界工作, 代表世界上最重要的制药公司, 设备和生物技术公司. 的ir experience and knowledge vary considerably: Some are just starting their careers, while others have been involved in industry for thirty years or more.   

With students and 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 and food industries also participate to gain a deeper understanding of quality practices and regulatory compliance.  

是什么让药物监管科学硕士与众不同?

  • 一年中的任何时间(秋季、春季或夏季)都可以开课。
  • Enjoy weeknight courses that are offered in an interactive, online format
  • Take up to three courses before applying to the MS degree
  • 与美国各地的专业人士建立联系.S. 和世界
  • No thesis required; complete 30 credits (10 courses) to earn the degree

程序的格式 & 课程 

课程 are offered online on weeknights during three semesters a year. 该计划可以在兼职的基础上进行, enabling working professionals to earn a degree while being employed full time. Through careful planning, the degree may be finished within two to three years. 

Required courses for the MS in Pharmaceutical Regulatory Sciences include the following.

  • Pharmaceutical Manufacturing I: Preformulation/Formulation (8003) 

  • Pharmaceutical Manufacturing II: Solid Dosage Forms (8004) 

  • 医药生物科技(8005) 

  • 物理药房(8006)——只在偶数年的春天提供

  • Regulatory Sciences: Managing the Guidelines for Quality (5575)

  • IND/NDA意见书(5495)

  • 设施、公用事业及设备(5468)

  • Chemistry, Manufacturing and Controls (CMC) (5576 or 5577) 

选修课 

One elective in pharmaceutical science and one elective in RA and QA from the following courses. 

药学选修课 

  • 药物分析(8002) 

  • 应用生物制药(8007) 

RA和QA选修课(学生必须选一门) 

  • 高纯水系统(5478) 

  • 清洁验证(5516) 

  • 计算机系统验证(5498) 

  • 疫苗:RA和QA问题(5572) 

  • 生物制剂/生物仿制制药(5515)

  • 规管策略(5606) 

Learn more about the 药物监管科学硕士.

参见课程设置. 

需求 

  • 必须修满30个学分, including 24 required and six elective credits from courses listed above. 必修课程应先完成必修课程, since they provide a foundation of knowledge for subsequent coursework. 

  • Students may receive a maximum of six semester hours of transfer credit from other schools, provided the courses are found to be the equivalent of courses offered in Temple’s MS in Pharmaceutical Regulatory Sciences, 获得B或更高的成绩, 课程不超过5年. 

  • 学生将有五年的时间来完成学位. 不需要研究或论文. 

项目联系人

温迪1 是RA和QA研究生项目的副院长吗. 
电话: 267-468-8560 
电子邮件: qara@wikiwagsdisposables.com 

彼得Doukas 是RA和QA的学术协调员吗. 
电话: 215-707-7883 
电子邮件: 彼得.doukas@wikiwagsdisposables.com 

吉恩·韦斯特布鲁克 是负责申请的行政协调人吗. 
电话: 267-468-8559 
电子邮件: QARA2@wikiwagsdisposables.com 

斯瓦特•纳加尔 主任是研究生院的吗. 
电话: 215-707-4948 
电子邮件: phscgrad@wikiwagsdisposables.com 

学费 & 费用

In keeping with Temple’s commitment to access and affordability, this program offers a competitive level of tuition with multiple opportunities for financial support.

学费是一样的, 课程是否在线, 校园, part of a certificate program or part of another master’s program at the 药学院.

宾夕法尼亚居民的课程: $3,393
非居民每门课: $4,218

学费 rates at 亿德体育 are set annually by the university and are affected by multiple factors, including program degree level (undergraduate or graduate), 课程负荷(全日制或非全日制), 居住在州内或州外, 和更多的.

你可以看到完整的 Cost of Attendance breakdown on the Student Financial Services website.

认证

亿德体育’s departments and programs are accredited by the 中部州高等教育委员会.

PH-PRS-MS

回到学术领域更多药物监管科学硕士