Clinical Trials Certificate Program

Program Overview (online, part-time only)

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 commericialization. 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 Clinical Trials Certificate Program 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.

videocameraQuick video outlining the UGA Program (.avi file) (3 mins 24 secs).

 

UGA's BioPharma graduate offerings cover:

  • Pharmaceuticals
  • Biologics
  • Medical Devices
  • Veterinary Products
  • Combination Products
  • International Regulations

Course Overview

17 total semester hours
Course topics include:

  • Intro to the Pharmaceutical, Biotechnology & Device Industries (4 hrs)
  • Biostatistical Applications for Pharmaceutical & Biotechnology Industries (3 hrs)
  • Ethical Issues in Research (3 hrs)
  • Clinical Trials Design & Monitoring (4 hrs)
  • Project Management in Clinical Trials (3 hrs)

Sample part-time schedule

Fall Semester

  • Intro to the Pharmaceutical, Biotechnology & Device Industries (4 hrs)
  • Ethical Issues in Research (3 hrs)

Spring Semester

  • Clinical Trials Design and Monitoring (4 hrs)

Summer Semester

  • Biostatistical Applications for Pharmaceutical & Biotechnology Industries (3 hrs)
  • Project Management in Clinical Trials (3 hrs)