生物制剂和生物类似药:监管方面的证书

的 生物制剂和生物类似药证书:监管方面 在 药学院 at 威尼斯赌场网站 helps students ga在 knowledge and credentials needed to work 在 U.美国和全球有关生物制剂和生物仿制药的法规. 这个证书是药学院颁发的 法规事务(RA)和质量保证(QA)研究生课程.

的 生物制剂和生物类似药:监管方面的证书 explores the following topics. 

  • Regulatory issues that are unique to biologics and biosimilar drug manufacturers
  • 的 current regulatory and technical/scientific issues involved in developing biological products in major International Council for Harmonisation of Technical 需求 for Pharmaceuticals for Human Use (ICH) regions
  • 临床, 制造业, regulatory and 战略 issues that challenge the path to global commercialization of a biological product 
  • 指导生物仿制药开发的原则 
  • 生物仿制药开发与创新药物开发有何不同 
  • 生物制剂和生物仿制药与化学合成药物有何不同 
  • 的 analytical methods used to characterize biologics and how analytical testing differs from small molecule testing 
  • 的 quality by design principles related to the development, 制造业 and testing of biologics 

This specialized curriculum delves into the requirements of major ICH markets for biologics and biosimilar products. 的 certificate builds a strong foundation 在 biologics and biosimilar regulatory landscape. 通过课程, students are exposed to key trends and controversies facing the biologics and biosimilar industry.  

的 生物制剂和生物类似药证书:监管方面 enables students to sharpen their knowledge of this industry niche without committing to the entire master’s degree. This certificate provides the tools and information to understand how biologics and biosimilars are regulated nationally, 区域和全球.  

Executive recruiters often call Temple’s RA和QA office seeking candidates with demonstrated knowledge of the regulations governing this discipline. 的 生物制剂和生物类似药证书:监管方面 provides students with credentials from Temple’s well-respected RA和QA graduate program, 给他们在关键的美国打下坚实的基础.S. 以及影响生物制品和生物仿制药的全球法规. 证书对双方都有效 在RA和QA部门担任硕士 applicants and MS graduates, who can expand their career opportunities with this new credential. 

学习目标 

Upon completion of the 生物制剂和生物类似药证书:监管方面, 学生将更好地理解以下内容.  

  • U.S. 以及生物制剂和生物仿制药的全球监管格局

  • 生物制剂和小分子的区别

  • 跨学科药物开发的复杂性和挑战.g., toxicology; clinical; and 化学, 制造业 and controls (CMC)

  • 的 strategy for preclinical and clinical studies as applied to biologics and biosimilar products 

  • 生物制剂和生物类似药CMC策略的基础

邮政局长的证书

Students have the option to complete a post-master’s curriculum in biologics and biosimilars: regulatory aspects. 这张硕士后证书探讨了监管, 战略, technical and scientific issues that are unique to biologics and biosimilar drug manufacturers. 申请这个15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 Post-master’s Certificate in Biologics and Biosimilars: Regulatory Aspects.

药学院法规事务与质量保证 

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;   

  • 拥有来自工业界和美国的优秀专家教师.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

获得生物制剂和生物类似药:监管方面的证书, 强烈建议学生获得生物学学士学位, 化学, 工程, 药店, 物理或相关领域, 从认可的高等学府毕业.  

证书可以自己获得，也可以在去学校的路上获得 在RA和QA部门担任硕士. 要获得证书, five of the following courses must be completed within a four-year period with an overall B (3.0)平均. 

学生必须完成三门必修课. 

  • 药物开发(RAQA 5459) 

  • 生物制剂/生物类似药:监管概述(RAQA 5515) 

  • 全球cmc -生物制剂(RAQA 5577) 

学生必须完成下列课程中的两门选修课. 

  • 无菌产品生产(RAQA 5492) 

  • 规管意见书(RAQA 5514) 

  • 临床药物安全与药物警戒(RAQA 5538)或5571* 

  • RAQA专题-临床试验的最新趋势(RAQA 5560) 

  • 上市后安全监测(RAQA 5571)或5538*  

  • 疫苗:类风湿关节炎和质量保证问题(RAQA 5572)  

*学生可选修 5571 or 5538，但不是两者都有.

All courses must be completed from 威尼斯赌场网站’s RA和QA graduate program. 不接受其他院校的转学分. 如果学生已经在美国认可的大学完成了相同的课程.S. 研究生院, the student may petition the RA和QA program to waive that course and take another approved elective in its place. This request must be made in writing and approved before the student pursues the certificate. 

Learn more about the 生物制剂和生物类似药:监管方面的证书. 

参见课程设置.

需求 

  • 考生必须正式申请并遵循 申请程序 (申请表格、成绩单影印本及完成通知书).  

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

  • 证书必须在四年内完成.  

  • Students must apply for the certificate no more than one year after completing the course requirements. 

  • Students interested in pursuing the RA和QA MS degree may apply all credits earned 在 certificate towards 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. 

了解更多有关申请流程的信息.

相关研究生学位

学费 & 费用

为了与坦普尔大学对获取和负担得起的承诺保持一致, 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, 包括课程学位水平(本科或研究生), 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 学生财务服务网站上的出勤费用明细.

认证

威尼斯赌场网站的院系和专业都获得了美国威尼斯赌场网站协会的认证 中部州高等教育委员会.

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