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.
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U.S. 以及生物制剂和生物仿制药的全球监管格局
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生物制剂和小分子的区别
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的 complexities and challenges in drug development across disciplines, e.g., toxicology; clinical; and 化学, 制造业 and controls (CMC)
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的 strategy for preclinical and clinical studies as applied to biologics and biosimilar products
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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.