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 Affairs 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 Affairs.
- 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)
- Intro to the Pharmaceutical, Biotechnology & Device Industries (4 hrs)
- Biostatistical Applications for Pharmaceutical & Biotechnology Industries (3 hrs)