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UGA and GT FastTrack page1 UGA RA Certificate Program and Georgia Tech

Regulatory Affairs (RA) Fast Track Initiative

for Georgia Institute of Technology

Graduate Students interested in biomedical industries

BioPharma Regulatory Affairs Certificate Program

Eligibility and Application Procedures for GT BME Graduate Students

What is Regulatory Affairs (RA)? Regulatory Affairs (or Sciences) is an interdisciplinary profession within federally regulated industries, such as pharmaceutical, biologics, medical devices, and animal health products, that ensures an organization’s compliance with all federal regulations and laws.

What is the UGA BioPharma Certificate Program?  The University of Georgia (UGA), College of Pharmacy offers an online graduate certificate in the area of BioPharma Regulatory Affairs.  It consists of four (4) courses or 14 credit hours.
 
Who should consider this option? As an engineer, if you are considering a career path in the healthcare industry, academia, or government, you need to be aware of regulatory issues regarding healthcare product development.   Regulatory issues impact every aspect of the product lifecycle from clinical research, to manufacturing, marketing, and post-market surveillance.

What is the UGA RA Fast Track Initiative?  The UGA initiative utilizes the Atlanta Regional Council for Higher Education (ARCHE) Cross Registration Program offering access to courses not offered on your home campus.  The RA Fast Track Initiative allows you take courses in the UGA Regulatory Affairs Program expediting the application processes.

Why should I consider this UGA Program?  The University of Georgia’s BioPharma Regulatory Affairs Program addresses the fundamental regulatory needs for the following types of FDA-regulated products:

l Pharmaceutical          l Medical Devices          l Biologics    
l Combination Products          l Animal Health Products


Upon completion of the four-course sequence, you will receive a departmental graduate certificate in Regulatory Affairs from The University of Georgia.

Online & Part-time
Due to the rapidly expanding biomedical and life science industries, an increase in the number of Regulatory Affairs professionals is needed to maintain compliance with regulatory policies and procedures for multiple product technologies. The Regulatory Affairs Graduate Certificate Program provides a foundational core curriculum for individuals who wish to supplement their primary discipline with education and application of regulatory affairs or transition into regulatory affairs positions.  Convenient education is crucial for busy professionals to gain and maintain an understanding of the scientific and technical background required of biomedical regulated industries.   The UGA program plan is delivered by Internet-based instruction, with occasional face-to-face sessions on the UGA Gwinnett Campus using evening or weekend formats.

 

Certificate Program Plan

14 total semester hours
Course topics include:

  • Intro to Pharmaceutical, Biotechnology & Device Industries (4 hrs)
  • Food and Drug Law (3 hrs)
  • Current Good Manufacturing Practices (4 hrs)
  • Ethics in Research (3 hrs)

 

Sample part-time schedule

Fall Semester

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

Spring Semester

  • Food and Drug Law (3 hrs)

Summer Semester

  • Current Good Manufacturing Practices (4 hrs)

 

Eligibility and Application Procedures for GT Engineering Graduate Students interested in medical product development.

 

For questions or information on UGA’s RA Fast Track initiative, please contact the RA department at regaffairs[at]rx.uga.edu or 678-985-6809.

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