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计划概述(只在网上兼职)

Geared toward a wide range of professionals, the Clinical Trials Design & Management Certificate Program provides a foundation for preparing candidates to lead and to manage the development and implementation of scientifically valid clinical study designs including monitoring of clinical trials and directing daily clinical trial operations. The interdisciplinary program encompasses critical core competency areas including biostatistics, federal regulations, bioethics and project management as integral parts of drug product development and medical device design validation required for federal regulatory market clearance and initial commercialization. The program plan is ideal for working professionals and consists of 17 semester credit hours, delivered by Internet-based instruction, with occasional face-to-face sessions at the UGA Gwinnett Campus. The program is part of UGA’s Regulatory Sciences Graduate Education Program. The 临床试验证明程序 offers graduate credit courses leading to a UGA certificate and, if a student completes additional graduate courses, the certificate course work may be applied toward a Master’s Degree in Pharmacy with an emphasis in Regulatory Sciences.

UGA的生物制药产品的研究生涵盖:

  • 药品
  • 生物制剂
  • 医疗设备
  • 兽药产品
  • 组合产品
  • 国际法规

下载的临床试验证明程序手册(pdf)

课程大纲

17总学分

课程主题包括:

  • PHAR 6010E: Intro to the Pharmaceutical, Biotechnology & Device Industries (4 hrs)
  • PHAR 7100E: Biostatistical Applications for Pharmaceutical & Biotechnology Industries (3 hrs)
  • PHRM 7230e:在研究中的伦理问题(3个小时)
  • PHAR 6200E: Clinical Trials Design & Monitoring (4 hrs)
  • 药业6210e:项目管理在临床试验中(3个小时)
样品部分时间进度

秋季学期

  • Intro to the Pharmaceutical, Biotechnology & Device Industries (4 hrs)
  • 在研究中的伦理问题(3个小时)

春季学期

  • 临床试验设计和监测(4个小时)

夏季学期

  • Biostatistical Applications for Pharmaceutical & Biotechnology Industries (3 hrs)
  • 项目管理在临床试验中(3个小时)