The UGA RA Programs are academic graduate programs designed to prepare Regulatory Affairs 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

    David Mullis, Jr., Ph.D., R.A.C., FRAP, is an associate professor with the College of Pharmacy. He serves as the Director of the Graduate Education in Regulatory Affairs Science curricula.

    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.

    Cindy Davenport, M.L.S., is the Administrative Specialist for this program provides office support and educational coordination for both faculty and students.

    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

    Ron Arkin , MS, Instructor, Regulatory Affairs Graduate Education Program, UGA College of Pharmacy

    Fran Akelewicz, MS, Instructor, Regulatory Affairs Graduate Education Program, UGA College of Pharmacy

    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

    David Mullis, Jr., Ph.D., R.A.C., FRAP, is an associate professor with the College of Pharmacy. He serves as the Director of the Graduate Education in Regulatory Affairs Science curricula.

    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

    George Francisco, Pharm.D., Associate Dean, UGA College of Pharmacy

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

    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

    David Mullis, Ph.D., RAC, FRAPS, Director, Regulatory Affairs Graduate Education Program, UGA College of Pharmacy

    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

    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

    David Mullis, Jr., Ph.D., RAC., FRAPS, Director, Regulatory Affairs Graduate Education Program, UGA College of Pharmacy

    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?

  • Latest News

    1) The next admission is Fall Semester 2018: The deadline for domestic applications is: June 1, 2018. The deadline for international applications is April 15, 2018. This includes the RA Certificate Program and MS Programs. Clinical Trials Certificate Program admits for Fall Semester only.

    UGA Graduate School http://grad.uga.edu degree codes for our Certificate Programs (Regulatory Affairs and Clinical Trials certificates) may be found under “Online Certificate Programs” beginning with the title “Pharmaceutical and Biomedical  Regulatory Affairs or Clinical Trials.” Here, the degree codes needed for the certificate program required by Graduate School online application will be listed.

    2) The UGA Biomedial Regulatory Sciences Program is pleased to announce the 42nd Annual International GMP Conference. The dates of this conference are March 12-15, 2018. Please visit the Conference’s website for more details, internationalgmp.com/.

    3) GRE Waiver Request: Under certain circumstances, such as an existing graduate degree or significant work-related experience in the health product industry, a waiver of the GRE requirement may be considered. No waiver request is guaranteed.

    4) The Regulatory Sciences Department is pleased to announce its Fast Track Initiative for Graduate Students in Georgia Tech’s various Engineering Programs, specifically for students interested in biomedical product development.

  • Contact Us

    Regulatory Sciences and Clinical Trials Programs are units within the University of Georgia’s College of Pharmacy, under the Division of Outreach & Nontraditional Education.