制药监管科学理学硕士
The 制药监管科学理学硕士 in the School of Pharmacy 威尼斯赌场网站(Temple University)解决了对精通监管科学的专业人士的迫切需求. 课程包括制药科学与法规事务(RA)和质量保证(QA)。, 弥合这些领域之间经常存在的知识差距. This master of science degree is part of the RA and QA graduate program.
What is regulatory science?
美国食品和药物管理局(FDA)将监管科学定义为“开发新工具的科学”, standards and approaches to assess the safety, efficacy, quality and performance of FDA-related products.“受监管的行业和监管机构都需要了解复杂的监管整合的专业人士, 将受监管的医疗保健产品推向市场所需的质量实践和科学知识.
药物科学课程侧重于治疗产品开发和制造的核心科学原理. RA和QA课程提供了强有力的法规框架和质量实践, addressing scientific methods needed to assure safety, efficacy, quality and consistent performance.
The curriculum draws upon the school’s world-renowned MS program in RA and QA. 课程由积极从事研究的制药科学家以及目前从事研究和开发的行业专家讲授, drug development, regulatory affairs, manufacturing, and validation.
Individuals pursuing this master’s 在监管科学研究生课程必须有很强的科学背景, 包括自然科学的本科或研究生学位吗.
药学院法规事务与质量保证
第一所开设质量保证和监管事务研究生课程的大学, 坦普尔大学药学院继续在这个充满活力的专业学科中树立黄金标准. Since 1968, 这所学校一直走在行业教育的前列, 在RA和QA方面提供的课程比其他任何类似的研究生课程都多. 每年我们都会继续增加和完善课程，以纳入监管科学的最新趋势.
RA和QA课程让学生接触到制药行业的真实发展, 从目前的质量实践到国内和全球监管的最新趋势. Throughout their course of study, RA和QA学生对收益风险评估有了更大的认识, regulatory intelligence, data mining and statistical relevance, 以及在全球范围内混合制药和监管科学的复杂性.
Careers and Networking
Most students work in industry, representing the world’s foremost pharmaceutical, device and biotechnology companies. 他们的经验和知识差异很大:有些人刚刚开始他们的职业生涯, 而另一些人已经从事工业30年或更长时间.
学生和教师来自300多家公司, the networking opportunities are tremendous. 每次课堂体验都将来自行业多个方面的个人经验结合在一起, 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, 医疗保健和食品行业也参与其中，以更深入地了解质量实践和法规遵从性.
为什么要在坦普尔大学的RAQA研究生项目中学习药物监管科学?
- 一年中的任何时间(秋季、春季或夏季)都可以开课。
- 享受以互动在线形式提供的工作日夜间课程
- 在申请硕士学位之前，最多修三门课程
- Network with professionals across the U.S. and world
- No thesis required; complete 30 credits (10 courses) to earn the degree
Program Format & Curriculum
课程在一年中三个学期的工作日晚上在线提供. The program may be pursued on a part-time basis, 使在职专业人士在全职工作的同时获得学位. 通过精心规划，学位可在两到三年内完成.
药物监管科学硕士课程包括以下必修课程.
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医药制造I:预制剂/制剂(8003)
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医药制造II:固体剂型(8004)
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Pharmaceutical Biotechnology (8005)
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Physical Pharmacy (8006)—offered only in spring of even-numbered years
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法规科学:管理质量指南(5575)
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IND/NDA Submissions (5495)
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Facilities, Utilities and Equipment (5468)
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化学，制造和控制(CMC)(5576或5577)
Electives
一门药学选修课程，一门RA和QA选修课程.
Pharmaceutical science electives
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Pharmaceutical Analysis (8002)
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Applied Biopharmaceutics (8007)
RA and QA electives (students must take one)
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High Purity Water Systems (5478)
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Cleaning Validation (5516)
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Computerized System Validation (5498)
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Vaccines: RA and QA Issues (5572)
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Biologics/Biosimilars (5515)
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Regulatory Strategy (5606)
Requirements
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Thirty credits must be completed, 包括上述课程的24个必修学分和6个选修学分. 必修课程应先完成必修课程, 因为它们为以后的课程提供了知识基础.
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学生最多可以从其他学校获得六个学时的转学学分, 惟有关课程与威尼斯赌场网站药物规管科学理科硕士课程相同, a grade of B or higher was earned, and courses are no more than five years old.
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学生将有五年的时间来完成学位. No research or thesis is required.
Program Contacts
Wendy Lebing 是RA和QA研究生项目的副院长吗.
Phone: 267-468-8560
Email: qara@tengenixs.net
Peter Doukas is the academic coordinator for RA and QA.
Phone: 215-707-7883
Email: peter.doukas@tengenixs.net
Jean Westbrook is the administrative coordinator for applications.
Phone: 267-468-8559
Email: QARA2@tengenixs.net
Swati Nagar is the director of graduate studies.
Phone: 215-707-4948
Email: phscgrad@tengenixs.net