全球临床和药物管制法规(GCPR)的科学硕士

一般信息

项目描述

全球临床和药物警戒法规中的MS重点关注临床试验和药物警戒学科,使PharmD毕业生能够在全球市场上担任临床试验项目经理,研究管理员,安全经理和安全总监的职位。该课程提供了管理和监督临床试验,监督记录保存,审查临床试验或上市后的安全数据以及解释结果所需的技能。

完成此学位后,学生将了解以下内容:

•需要药物警戒和临床法规;

•药物警戒和临床法规的发展;

•国内和国际对医疗保健产品的药物警戒和临床要求及法规;

•产品类型和地区之间的法规差异;

•产品整个生命周期中的药物警戒数据;

•具有上下文化和解释安全数据的能力;

•药物警戒和临床术语以及主要利益相关者;

•临床试验和药物警戒质量管理系统以及检查准备;

•在整个生命周期中进行医疗保健产品风险评估的关键概念和理由;

•行业中数据收集,统计和数据挖掘的重要性。

由于课程是在校园内和在线上的晚上和周末提供的,因此学生可以兼职学习该课程。

最后更新10 月 2020

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学校简介

TUSP, one of the oldest pharmacy schools in Pennsylvania, has roots that date back to 1901. Today, TUSP has grown into a dynamic, influential name in pharmacy research and education. In 2010, the Carn ... 更多信息

TUSP, one of the oldest pharmacy schools in Pennsylvania, has roots that date back to 1901. Today, TUSP has grown into a dynamic, influential name in pharmacy research and education. In 2010, the Carnegie Foundation for the Advancement of Teaching recognized Temple as one of only 99 public and private universities to merit an RU/H classification, indicating high research activity. Our award-winning research and faculty help shape our legacy and give our students something to celebrate and aspire to. Temple’s students, after all, are at the center of our efforts and success. Our Pharm.D., Graduate Degrees in the Pharmaceutical Sciences and Regulatory Affairs and Quality Assurance (RAQA) graduate program provide our diverse and talented student body with the opportunities they need to help them meet their various professional and educational goals. As a school, TUSP does everything possible to contribute to the solid reputation of Temple University and promote innovation and progress in the pharmaceutical sciences and pharmacy practice. Every year, TUSP graduates cultivated, informed, ethical practitioners and researchers out into the world. Last year we proudly graduated 98.6% of our Pharm.D. professional class, solidifying our graduation rate in the top third percentile of U.S. pharmacy schools. 收起