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FAQs: UGA Regulatory Affairs Masters Program

Frequently Asked Questions

General Program Information

  1. What is BioPharma Regulatory Affairs (RA)?
  2. How do I contact the Regulatory Affairs Master’s Program?
  3. How do I contact the UGA Graduate School?
  4. I am a working professional and do not have time to devote to a full-time program. What are my options to participate in these programs? Will I need to take time off from work to participate?
  5. Is this program offered as full-time?
  6. I have an undergraduate degree in a non-healthcare or non-science area. Can I apply to the RA program?
  7. Is the RA Master’s program self-study or self-paced?
  8. Am I able to participate in the MS RA Program if I am living outside of Georgia?
  9. At the conclusion of this program, is there a job placement service within UGA?
  10. Credit Hours: What are the credit hours for this program?
  11. Do the four RA Certificate Program courses apply to the MS in Regulatory Affairs degree program if I decide to apply to the MS Program? What about the five course for the CT Certificate Program?
  12. Transfer credit hours: Is it possible to transfer credit hours for a similar course that I took at another institution?
  13. What is the difference between the MS thesis-track and the MS non-thesis track?
  14. Class Meetings: Where will the live class meetings take place? Will I need to take time off from work to participate?
  15. I am enrolled in two degree programs. May I use credit hours in this degree program to satisfy course/credit hour requirements for my secondary degree program?

Applying to the Program

  1. How do I apply to The MS program?
  2. Why do I need to apply to both the UGA Graduate School and the UGA Regulatory Affairs Office?
  3. Admission Tests: Is there a required admissions test for the MS program?
  4. What is the application deadline for materials in order to be considered for admission into the MS program?
  5. What does the UGA Graduate School mean by "Continuous Enrollment"?

International Applicants

  1. Can international students apply to this program? Deadlines?
  2. Does this department offer sponsorships for international students?
  3. Do I need to provide TOEFL (Test of English as a Foreign Language) scores for the Master’s Program? Where can I find information on Testing Centers for the TOEFL? What is the minimum score required?

Registration, Fees and Payment

  1. How can I find out when or what MS courses will be taught in a given semester?
  2. How do I register for courses in the program?
  3. Are there prerequisites classes or a sequence of courses to follow?
  4. How much does the MS Regulatory Affairs Programs cost? E-Rate?
  5. How do I pay for the courses that I take?
  6. When is the payment for my classes expected?
  7. What is the deadline to register for the Masters courses?
  8. Does the Regulatory Affairs Office offer financial aid?
  9. Dropping, Adding, Withdrawing and Refunds of tuition dollars.

Distance Learning & Computer Technologies

  1. I am not certain I am cut out for distance learning. How might I assess my motivation and interest in this type of learning?
  2. Do I have to purchase books and course materials separately?
  3. How does an online course work?
  4. What is eLC? How does it work?

General Program Information

  1. What is BioPharma Regulatory Affairs?
    Regulatory Affairs professionals are employed in industry, government and academia and provide a range of services related to the regulation, development, manufacturing and marketing of pharmaceuticals, medical devices, in vitro diagnostics, biologics, biotechnology, nutritional products, cosmetics, and veterinary products.
  2. How do I contact the Regulatory Affairs Master’s Program?
    The RA Master’s Program is administered through the UGA Regulatory Affairs Graduate Education Office. The mailing address is: BioPharma Regulatory Affairs Graduate Program The University of Georgia Gwinnett Campus 2530 Sever Road Lawrenceville, Georgia 30043-4005 Phone: 678-985-6809 Fax: 770-357-3805 Email: regaffairs[at]rx.uga.edu.

  3. How do I contact the UGA Graduate School?
    Information for contacting the UGA Graduate School is found at www.grad.uga.edu.
  4. I am a working professional and do not have the time to devote to a full-time program. What are my options to participate in this program? Will I need to take off from work to participate?
    This program is geared toward the working professional. It is designed to be completed on a part-time basis. The primary mode of delivery is via the web (about 95%). However, a few face-to-face meetings (about 5%) are required. These face-to-face meetings are generally conducted on weekends at the UGA - Gwinnett Campus. For out-of-state students, live meetings may be scheduled via teleconference or web conference.
  5. Are these programs offered as full time programs?
    No, the MS Programs is offered as a part-time program only.
  6. I have an undergraduate degree in a non-healthcare or non-science area. Can I apply to the RA or CT program?
    The RA professions are multi-disciplinary. RA professionals often come with diverse backgrounds. Generally, most have either a science or technical background. RA professionals are often required to understand scientific, engineering, or technical concepts. Yet, RA professionals also need skills in communication, negotiation, project management, and financial management. If you are interested in our program but you do not possess the science or technical background, we encourage you to seek out volunteer opportunities (such as at your local blood bank); and in your program application provide a description of your interest in this profession emphasizing your existing skills (such as experience with Project Management).
  7. Is the RA MS Program self-study or self-paced?
    No. This program is not self-study, nor done at a self-paced format. The Master’s program operates on a traditional academic calendar (the semester system) and traditional academic processes such as admissions criteria and processes; as well at course tests, quizzes, papers, with due dates, etc. Where these programs differ is in the mode of delivery. This program is offered via the web using a course management system called eLC. Furthermore, the program is geared to the adult learner and therefore set up to be taken on a part-time basis--generally, one to two classes at a time. Students considering the Graduate Education programs should be disciplined and self-directed in order to be successful. Students are required to keep up with the course work and all deadlines.
  8. Am I able to participate in the MS RA program if I am living outside of Georgia?
    Yes. Courses are offered online using eLC, a web-based course management system. These programs can be completed via the web with some live sessions via teleconference or web conference. Therefore, out-of-state residents can fully participate in the program.
  9. At the conclusion of this program, is there a job placement service within UGA?
    At present, the UGA Regulatory Affairs Office does not have a formal job placement service. However, the program administrators have contacts throughout industry and will post available job opportunities on the web or through email. It is the student's responsibility to follow up on these postings. Furthermore, students in the program may take advantage of UGA's Career Center. For additional information on the Career Center, please visit: www.career.uga.edu.
  10. Credit Hours: What are the credit hours for RA Master’s Program?
    a. Thesis-track: 38 semester hours (minimum). b. Non-thesis track: 39 semester hours (minimum)
  11. Do the four RA Certificate Program courses be applied to the MS in Regulatory Affairs degree program if I decide to apply? What about the five courses for the CT Certificate Program?
    Yes, the credit hours earned in both the RA Certificate and Clinical Trials Programs can be applied to the Master’s Program should you decide to apply to the MS Program. Like all graduate credit hours, however, there is a time limit on the credit hours you accumulate in the certificate program. All requirements for a master’s degree must be completed within six years beginning with the first registration for courses, including the Certificate Program courses, on the student’s program of study. grad.uga.edu/index.php/current-students/policies-procedures/academics/types-of-degrees-offered/masters-degrees/.
  12. Transfer credit hours: Is it possible to transfer credit hours for a similar course that I took at another institution?
    Yes. It is possible to transfer a limited number of credit hours for the Master's Program from another accredited university. The policy, however, is stringent. For the Master's Program, the student may transfer only 6 credit hours. The student must be able to provide his/her course grade and course syllabus for each class that he/she wishes to transfer. You must receive prior approval from the RA Program Director before any credit hours can transfer. Neither certificate programs will accept transfer credit. The transfer credit applies ONLY to the MS Program.
  13. What is the difference between the MS thesis-track and the MS project-thesis track?
    There are two pathways for the UGA M.S. degree in Regulatory Affairs. The Project (or non-thesis) pathway requires at least 39 semester hours, which includes an applied project or internship and a comprehensive examination. The thesis pathway requires at least 38 semester hours, which includes the development and oral defense of a research-based thesis. Time to complete the thesis program frequently takes longer to complete than the Project (non-thesis) option. This is because it requires independent research, with close scrutiny of research methodology and assessment of results. In addition, writing a thesis is time-consuming and must conform to stringent research guidelines. Please review this link for more specific information comparing the MS thesis and non-thesis tracks, ra.rx.uga.edu/program_info/reg_affairs_masters/nonthesis.php.
  14. Class Meetings: Where will the live class meetings take place? Will I need to take time off from work to participate?
    The face-to-face meetings will occur on the University of Georgia Gwinnett Campus. The location of this campus is Lawrenceville, Georgia, and was selected as the administrative location of the Regulatory Affairs Program because of its proximity to Atlanta. Most face-to-face meetings will occur Saturday mornings so as not to interfere with traditional work schedules. Attendance for face-to-face meetings is required and dates for these live sessions are provided at the beginning of each semester. If you are an out-of-state student, we will make accommodations for your participation.
  15. I am enrolled in two degree programs. May I use credit hours in this degree program to satisfy course/credit hour requirements for my secondary degree program? No. the use of credit hours used to satisfy the requirements of one degree cannot be used to satisfy the requirements of another degree. For additional information on this Graduate School policy, please visit grad.uga.edu/index.php/current-students/policies-procedures/academics/use-of-credit/.

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Applying to the Programs

  1. How do I apply for to the MS Program?
    It is the applicant's responsibility to familiarize her/himself with the application criteria and to meet all noted deadlines. Follow closely the application directions outlined at ra.rx.uga.edu/program_info/reg_affairs_masters/admission_criteria.php.
  2. Why do I need to apply to both the UGA Graduate School and the UGA Regulatory Affairs Office?
    Each department or office has its own application and admission criteria. The UGA Graduate School assures accreditation of the undergraduate or graduate degrees, as well as the appropriateness of the GRE scores, and/or TOEFL scores. The Regulatory Affairs Office has a separate admission criteria considering work experience, level of interest, etc.
  3. Admission Test: Is there a required admissions test for MS Programs, like the GRE (Graduate Records Examination)?
    Yes. The GRE is required for consideration for admission into the MS program. We accept NO other admissions tests. It must be the GRE. It is recommended that the applicant take the examination no later than 6 - 8 weeks prior to the admission deadline. International students should allow more time. The program will not accept scores that are more than 5 years old. Other standardized test scores such as the LSAT, PCAT, MCAT will not be accepted in lieu of the GRE scores. GRE scores are assessed in relation to other factors such as GPA, background, and interview for determination of admission and we welcome applications of all qualified persons with a sincere interest in Pharmaceutical and Biomedical Regulatory Affairs. For additional information on the GRE test, you may check the GRE website at www.gre.org or call 1-800-GRE-CALL. Also, University Testing Services has information on their site: testing.uga.edu or you can call them at 706-542-3183.
  4. What is the application deadline for materials in order to be considered for admission into the MS Program?
    Our program takes applications on an on-going basis. However, to be admitted for a specific semester, your completed application must be turned in to our office and to the UGA Graduate School by the deadlines noted below. Applicants are responsible for completing a timely application. The Regulatory Affairs Office and UGA Graduate School are not responsible for delays caused by postal or courier services. Admissions decisions are made only on completed files.
    • Application Deadlines
      • Domestic Applicants: Fall Semester - June 1; Spring Semester - November 1
      • International Applicants: Fall Semester - April 15; Spring Semester - October 15
  5. What does the UGA Graduate School mean by "Continuous Enrollment"?
    Essentially, the policy is that degree-seeking graduate students must register for a minimum of three (3) hours for at least two (2) semesters in each academic year (Fall, Spring, Summer). As you plan your studies at the University of Georgia, please become familiar with the policy in the Graduate Bulletin at - grad.uga.edu/index.php/prospective-students/international-application-information/.

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International Applicants

  1. Can international students apply for this program? Deadlines?
    Yes. We welcome international applicants. In addition to the academic department and UGA Graduate School admission materials, prospective international students are required to provide additional supplemental materials. Please review grad.uga.edu/index.php/prospective-students/international-application-information/. Application Deadlines - Deadlines for international applicants are as follows: • Fall semester - April 15 • Spring semester - October 15
  2. Does this department offer sponsorships for international students?
    No. the Regulatory Affairs Office does not offer various student visas or monetary assistantships. Because we are a distance learning, part-time only program, international students can participate from their country.
  3. Do I need to provide TOEFL (Test of English as a Foreign Language) scores for the Master’s Program?
    Where can I find information on Testing Centers for the TOEFL? What is the minimum score required? Yes. In addition to the other application materials, TOEFL scores are also required for the MS Program if you received your last degree from an institution where English is not the primary language. You will need to provide official copies of your TOEFL scores to the UGA Graduate School in order to be considered for admission. Official scores are those sent to the Office of Graduate Admissions by Educational Testing Service. The scores may not be more than two years old. The minimum scores are: 213 (computer-based test) or 550 (paper-based test). Information on the TOEFL and TSE can be found at the following sources: E-mail: TOEFL@ets.org; Web: www.TOEFL.org Phone: 1-800-468-6335.

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Registration, Fees and Payment

  1. How can I find out when or what MS Regulatory Affairs courses will be taught in a given semester?
    For a list of upcoming courses, MS Students may refer to the link for Enrolled Students.
  2. How do I register for the courses in the program?
    Upon official admittance into the program, you will be notified through email of the specific directions for course registration. Students will then need to register for selected courses using the UGA ATHENA system at athena.uga.edu/. This is an online registration system.
  3. Are there prerequisites or a sequence of courses for the students to follow?
    Students are required to have the Introduction to Regulatory Affairs course, PHAR 6010, prior to signing up for any other courses except PHRM 7230, Ethics in Research. PHRM 7230 may be taken at any time in the student's course of study. If the student has significant regulatory or clinical trial experience, he or she may make a formal appeal to the Regulatory Affairs Program Director requesting the option to start the program without benefit of PHAR 6010. However, when the course is taught again, the student will be required register for it. The student may take the courses out of sequence, but it required to take PHAR 6010 at the next available opportunity.
  4. How much does the MS Programs cost? E-Rate?
    The University of Georgia has implemented an E-rate tuition schedule. Always check the Bursar's Office website for the most recent tuition costs. The URL is: www.bursar.uga.edu/tuition.html as tuition is subject to change. Applicants and student are responsible for keeping up with tuition costs. Under the new E-rate, tuition is broken down as follows: • Courses - cost per credit hour • Activities Fee - cost per semester • Technology Fee - cost per semester • Institutional Fee - cost per semester • Green Fee - cost per semester • . See also our Tuition page.
  5. How do I pay for the courses that I take?
    At the completion of the registration process through the UGA Athena system, you will be prompted to identify your method of payment. Your options are to pay with a credit card or to pay by check which can be sent through the mail.
  6. When is the payment for my classes expected?
    Student Account Payment Deadlines are listed at the Bursar's Office website. The URL is: www.bursar.uga.edu/. Look for the linked labeled Calendar & Payment Deadlines. Please review this site for information on when payment for classes is due.
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  8. What is the deadline to register for the Master’s course?
    Students can register anytime up to the start of classes. Once classes have commenced, the student will have about two weeks to register and pay for classes. Late fees may be charged within those two weeks. Refer to the Registrar's Office for specific information.
  9. Does the Regulatory Affairs Program offer financial aid?
    The Regulatory Affairs Office has no assistantships or financial aid opportunities. Federal loans may be available to Masters-level students or those who qualify. All financial aid is handled through the UGA Office of Financial Aid. For information on general financial aid opportunities of which you may take advantage, please go to www.uga.edu/osfa/. For questions on financial aid, please direct those inquiries directly to the Financial Aid Office at UGA.
  10. Dropping, Adding, Withdrawing and Refunds of tuition dollars.
    Please read the full policy on dropping, adding withdrawal from the University and possible refunds.

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Distance Learning and Computer Technologies

  1. I am not certain I am cut out for distance learning. How might I assess my motivation and interest in this type of learning?
    To determine whether online learning may or may not be appropriate, students 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 course, we highly encourage you to read What Make a Successful Online Student? at www.ion.uillinois.edu/resources/tutorials/pedagogy/StudentProfile.asp.
  2. Do I have to purchase books and course materials separately?
    Yes. All texts and course materials must be purchased separately. The students will be given specific instructions on purchasing materials prior to the start of class. It is the student's responsibility to make sure he/she has these materials.
  3. How does an online course work?
    These 15-16 week courses (11 weeks for summer semester) are divided into "content modules" each lasting between 1 to 2 weeks. It is primarily asynchronous learning, i.e. you will not have to be online at a specific time or date. There will be times, however, when you must be online at a specific time and date. These synchronous learning opportunities will be announced to the class ahead of time. In addition, you will have weekly lectures, assignments, quizzes and other exercise, all of which are outlined in the course syllabus.
  4. What is eLC? How does it work?
    eLC (e-Learning Commons) is the course management system used to deliver course content. It is an intuitive program allowing those students with minimal computer experience to participate in on-line learning. For more information on eLC, please visit: elc.uga.edu. During the Program Orientation, the Regulatory Affairs office provides training and instructions on eLC to those students without experience.