International Biomedical Regulatory Sciences

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

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., M.S., is the Assistant Director of the program, providing educational planning support and technical assistance in the development of courses for the Regulatory Sciences 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 Sciences Program.

Beverly Minor is an administrative support professional. She is responsible for student information database reports and other queries, eLC-related activities, and day-to-day administrative support.

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 Sciences Graduate Education Program, UGA College of Pharmacy

Robert Geiger, Ph.D., Faculty, Regulatory Sciences Graduate Education Program, UGA College of Pharmacy

Alexander Jacks, M.S., Faculty, Regulatory Sciences Graduate Education Program, UGA College of Pharmacy

Kristen Mandello, D.V.M.,Faculty, Regulatory Sciences Graduate Education Program, UGA College of Pharmacy

Samuel Silva, Ph.D., Faculty, Regulatory Sciences Graduate Education Program, 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 Sciences 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 Sciences Graduate Education Program, 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 Sciences Program

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

Grace Gowda, M.Pharm, Ph.D., RAC, Director, International Biomedical Regulatory Sciences 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., M.S., Regulatory Sciences Graduate Education Program, UGA College of Pharmacy

Institute for International Biomedical Regulatory Sciences

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