The UGA Regulatory Sciences Programs are academic graduate programs designed to prepare Regulatory Sciences professionals for careers in the Medical Device, Pharmaceutical, Biologics, and Animal Health business sectors. These programs are web-based and part-time programs. Course work uses a blended instructional approach of asynchronously delivered content and interactive project work taught by subject matter experts from industry, the university, and regulatory agencies to ensure that the content is current and relevant. Classes are intended to allow individual flexibility, yet are structured to progress student learning during the semester. Each semester is 15-16 weeks in length except for summer semester which is 11 weeks.

The mission of the UGA International Biomedical Regulatory Sciences Graduate Education Program is to provide graduate-level distance education designed to increase knowledge and develop competencies in biomedical regulatory and clinical processes that meet government regulations and that are critical in helping assure the development, manufacturing, and marketing of safe and effective medical products.

Programs of Study
Mission Statement

The mission of the UGA International Biomedical Regulatory Sciences Graduate Education Program is to provide graduate-level distance education designed to increase knowledge and develop competencies in biomedical regulatory and clinical processes that meet government regulations and that are critical in helping assure the development, manufacturing, and marketing of safe and effective medical products.

Faculty and Staff

Administrative Personnel

Grace Gowda is an associate professor in the College of Pharmacy’s extended campus in Gwinnett County. She serves as the Director of the International Biomedical Regulatory Sciences Program.

Johnna Hodges, M.Ed., is the Assistant Director of the program, providing educational planning support and technical assistance in the development of courses for the Regulatory Affairs Program. Her appointment is Academic Professional.

Arvinder Makkar, M.B.A., is the Program Coordinator I for the Department. She coordinates instructional and student services for both faculty and students of the Regulatory Affairs Program.

Core UGA Faculty for Graduate Studies

Michael Bartlett, Ph.D., Associate Dean for Science Education, Research and Technology, and Graduate Coordinator, UGA College of Pharmacy

Paul Brooks, Pharm.D., Ed.D., Associate Vice President, Office of Vice President for Public Service & Outreach, UGA

Seppe De Gelas, MS, Faculty, Regulatory Affairs Graduate Education Program, Division of Outreach & Nontraditional Education, UGA College of Pharmacy

Robert Geiger, Ph.D., Faculty, Regulatory Affairs Graduate Education Program, Division of Outreach & Nontraditional Education, UGA College of Pharmacy

Alexander Jacks, M.S., Faculty, Regulatory Affairs Graduate Education Program, Division of Outreach & Nontraditional Education, UGA College of Pharmacy

Samuel Silva, Ph.D., Faculty, Regulatory Affairs Graduate Education Program, Division of Outreach & Nontraditional Education, UGA College of Pharmacy

Randall Tackett, Ph.D., Professor, Department of Clinical and Administrative Pharmacy, UGA College of Pharmacy

Experts from the Biomedical industry and faculty from other units within the University System of Georgia also teach and mentor students enrolled in this program.

STEERING COMMITTEES
Regulatory Affairs Advisory Board

Michael Bartlett, Ph.D., Associate Dean for Science Education, Research and Technology, and Graduate Coordinator, UGA College of Pharmacy

Paul Brooks, Pharm.D., Ed.D., Associate Vice President, Office of Vice President for Public Service & Outreach, UGA

Robert Geiger, Ph.D., Faculty, Regulatory Affairs Graduate Education Program, Division of Outreach & Nontraditional Education, UGA College of Pharmacy

J. Griffin Doyle, J.D., University of Georgia Director of Federal Relations

Patty Fritz, Vice President, Regulatory Affairs, UCB Pharma, Inc.

Grace Gowda, M.Pharm, Ph.D., RAC, Director, International Biomedical Regulatory Affairs Program

Johnna Hodges, M.Ed., Regulatory Affairs Graduate Education Program, UGA College of Pharmacy

Robert T. McNally, Ph.D., President, GeoVax, Inc.

Randolph P. Martin, M.D., FACC, Associate Dean for Clinical Development, Professor of Medicine, Emory University School of Medicine

Alan G. Minsk, J.D., Partner & Leader Food & Drug Practice Team, Arnall Golden Gregory LLP

Chris Moder, ICAPP Program Director, University System of Georgia and The University of Georgia

Kevin Slatkavitz, Ph.D., Think Quality, LLC

Randall Tackett, Ph.D., Professor, Department of Clinical and Administrative Pharmacy, UGA College of Pharmacy

Barbara Wood, Director, Southeast Region, Food and Drug Administration (retired)

Regulatory Affairs Curriculum Committee

Michael Bartlett, Ph.D., Associate Dean for Science Education, Research and Technology, and Graduate Coordinator, UGA College of Pharmacy

Robert Geiger, Ph.D., Faculty, Regulatory Affairs Graduate Education Program, Division of Outreach & Nontraditional Education, UGA College of Pharmacy

Grace Gowda, M.Pharm, Ph.D., RAC, Director, International Biomedical Regulatory Affairs Program

Penny Northcutt, President, REGSolutions, LLC

Robert Coleman, National Drug Expert, retired from the Food and Drug Administration (retired)

Wayne Wiley, R. Ph., Senior Director, Regulatory Affairs, Recro Gainesville LLC.

Felipe Dolz, Ph.D., Executive Director, Regulatory Affairs, Merial, a Sanofi-Aventis Company

Don Ruggirello, Associate Director, Regulatory Affairs at Chattem, Inc

Saundra Granade, MS, VP Quality Americas, Cardinal Health

Paul Brooks, Pharm.D., Ed.D., Associate Vice President, Office of Vice President for Public Service & Outreach, UGA

Johnna Hodges, M.Ed., Regulatory Affairs Graduate Education Program, UGA College of Pharmacy

Distance Learning Self-Assessment

Here, you will find additional information about our program’s use of distance learning (DL) methodologies including DL assessment exercises. These tools will help to gauge your level of interest in being a distance learning student.

To determine whether online learning may or may not be appropriate for you, students and applicants are advised to assess their readiness, goals, and learning preferences prior to beginning an online course. To help students make the right decision about enrolling in an online program or course, we highly encourage you to read What Make a Successful Online Student?

Contact Us

Regulatory Sciences and Clinical Trials Programs are units within the University of Georgia College of Pharmacy, under the University of Georgia Institute for International Biomedical Regulatory Sciences.

Phone: 706-542-9256
Email:  gaiibrs@uga.edu
Website:  http://gaiibrs.uga.edu

 

 

Connect with the UGA College of Pharmacy