仿制药证书

的 仿制药证书 在 药学院 at 威尼斯赌场网站 features a specialized curriculum that delves into domestic and global regulations for generic products. 这个证书是学校颁发的 regulatory affairs (RA) and quality assurance (QA) graduate program. 

Starting with an overview of the drug development process, courses explore the global marketplace for generic drugs, building a strong foundation in generic regulatory issues, including the abbreviated new drug application (ANDA) process. Students learn the key trends and controversies facing the generic industry as well as how generic drugs are manufactured and regulated nationally and globally. Students also cover topics such as the issues unique to generic drug manufacturers as well as regulatory issues critical for industry professionals to understand how to help companies create safe and effective bioequivalent products.  

的 Certificate in Generic Drugs enables students to sharpen their knowledge of this industry niche without committing to the entire RA和QA理学硕士学位.  

学习目标 

Students completing the certificate will become familiar with the following topics. 

  • 国内和全球通用产品法规 

  • 仿制药的竞争环境

  • 制造科学和质量实践

仿制药硕士证书后

Students have the option to complete a post-master’s curriculum in generic drugs. This post-master’s certificate focuses on the regulatory issues that are critical for generic industry professionals to understand if they are to ensure that their companies create safe and effective bioequivalent drugs. 申请这个12学分的课程, applicants must hold a master’s degree in a 药店-related field and a bachelor of science degree in biology, 化学, 工程, 药店, 物理或相关领域.

Learn more about the 研究生 Certificate in Generic Drugs.

Regulatory Affairs and Quality Assurance at the 药学院 

50多年来，威尼斯赌场网站 药学院 提供了优秀的研究生课程 RA和QA. 

药学院  

  • 1968年开创了RA和QA研究生教育, offered the first RA和QA online degree program and offers the most comprehensive RA和QA curriculum;   

  • has outstanding expert faculty from industry and the U.S. Food and Drug Administration (FDA), assuring the latest developments and practices are taught; 

  • 吸引了来自生物制药的学生, 医疗设备, 医药及相关行业(化妆品), 食品和保健); 

  • schedules live courses with interactive discussions and workshops on evenings and weekends; 

  • has hundreds of students from across the country, facilitating great networking opportunities; and 

  • 为学生提供个性化服务.    

Certificates provide credentials from Temple’s well-respected RA和QA graduate program, 哪些可以适用于RA和QA硕士学位. 

程序的格式 & 课程 

申请仿制药证书, 学生必须有理科学士学位, 比如生物学, 化学, 工程, 药店, 物理或相关领域 from an accredited institution of higher learning.  

除了, students need a basic knowledge of pharmaceutical manufacturing processes, 例如完成 良好生产规范(5477) or 高级gmp定义“c”(5479).  

的 Certificate in Generic Drugs may be earned on its own or on the way to the MS in RA和QA. 要获得证书, five courses must be successfully completed within a four-year period with an overall B (3.0)平均.  

有两门必修课. 

  • 药物开发(5459) 

  • 仿制药法规:ANDAs (5473)  

Students must also complete three electives from the following.  

  • 全球生物制药产业(5458) 

  • Drug Dosage Forms (5499) or Solid Dosage Forms—Small Molecules (8004) 

  • 活性药物成分(api) (5513) 

  • 良好分销规范(药剂学5543) 

  • 全球药用辅料规例(5546) 

  • 全球CMC问题和监管档案(5576) 

  • Analytical Chemistry in Pharmaceutical Laboratories (5655) 

  • Special Topics: Current Issues Affecting the Generic Drug Industry (5650) 

All courses must be completed from 威尼斯赌场网站’s RA和QA graduate program. No transfer credits from other institutions are accepted. If a student has taken an identical course at an accredited U.S. 研究生院, the student may petition the RA和QA program to waive that requirement and take another approved elective in its place. This request must be made in writing and approved before the student pursues the certificate. 

了解更多关于仿制药证书的信息.

参见课程设置. 

需求 

  • 考生必须正式申请并遵循 申请程序. 

  • Only one certificate may be earned before students receive the MS. 

  • 的 Certificate in Generic Drugs must be completed within four years. 

  • Students must apply for the certificate within one year of completing all required coursework for the program. 

  • Students interested in pursuing the RA和QA MS program may apply all credits earned from the Certificate in Generic Drugs toward their graduate degree, provided they formally apply for admission to the MS program and are accepted by 威尼斯赌场网站’s 研究生院.

相关研究生学位

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 威尼斯赌场网站 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

威尼斯赌场网站’s departments and programs are accredited by the 中部州高等教育委员会.

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