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Specialized education and professional development for the Regulatory Affairs Professional.

Next admission is
Spring 2010. The deadline for application materials is:
Nov. 1, 2009.

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General Frequently Asked Questions (FAQs)

These frequently asked questions (FAQs) apply to all of the Regulatory Affairs Graduate Education Programs (Clinical Trials, Regulatory Affairs Certificates and MS Programs).

Key:
RA - Regulatory Affairs Certificate Program
CT - Clinical Trials Design Certificate Program
MS - Masters of Science in Pharmacy in Regulatory Affairs

Sections are divided into the following headings:

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General Program Information

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Applying to the Programs

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International Applicants

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Registration, Fees and Payment

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Distance Learning & Computer Technologies

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General Program Information

What is Pharmaceutical and Biomedical 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. For an interactive presentation on Reg Affairs, click here.

I would like to find out about more about the UGA Clinical Trials (CT) Certification program.

You may learn more about the UGA Clinical Trials Design and Management Certificate Program at our program's website. The URL is: www.rx.uga.edu/main/clinicaltrials/index.htm

I would like to find out about more about the UGA Regulatory Affairs (RA) Certification program.

You may learn more about the UGA Regulatory Affairs Programs, both Certificate and MS Programs, at our program's website. The URL is: www.rx.uga.edu/main/home/reg_affairs/index.htm.

What are the types of Regulatory Affairs educational programs offered by the UGA College of Pharmacy?

We currently offer a graduate certificate in Regulatory Affairs, a Masters of Science in Pharmacy with an emphasis in Regulatory Affairs degree, and a graduate certificate in Clinical Trials Design and Management.

Are these new programs at the University of Georgia?

Yes. The Regulatory Affairs Programs are new to the University of Georgia.

Do other universities or colleges offer similar programs?

The Regulatory Affairs Professional Society (RAPS) maintains an unofficial list of colleges and universities that offer degrees and courses in Regulatory Affairs, Clinical Trials, and other degree programs. Please visit their website at www.raps.org.

Is the Certificate in Regulatory Affairs offered by UGA College of Pharmacy the same as the Regulatory Affairs Certification offered by RAPS?

The Certificate Program offered by the University of Georgia is NOT the same as the Regulatory Affairs Certificate (RAC) offered by RAPS (The Regulatory Affairs Professional Society). Our Certificate program can assist you in your preparation for taking the RAC Exam, covering about 80% of the material on the RAC Exam.

How do I contact the Regulatory Affairs and / or Clinical Trials Programs?

The RA and CT programs are administered through the UGA Regulatory Affairs Graduate Education Office. The mailing address is:

Office of the Regulatory Affairs Graduate
Education Program
The University of Georgia Gwinnett Campus
2530 Sever Road
Lawrenceville, Georgia 30043-4005

Phone: 678-985-6809
Fax: 770-357-3805

RA Web site (Certificate & MS information): www.rx.uga.edu/main/home/reg_affairs/index.htm
RA Email: regaffairs@rx.uga.edu

CT Web site (Certificate information): www.rx.uga.edu/main/clinicaltrials/index.htm
CT Email: clinical@rx.uga.edu

How do I contact the UGA Graduate School?

Information for contacting the UGA Graduate School is found at www.gradsch.uga.edu.

I am a working professional and I do not have the time to devote to a full-time program. What are my options to participate in these programs? Will I need to take off from work to participate?

Our programs are geared toward the working professional. Our programs are designed to be completed on a part-time basis. The primary mode of delivery is via the world wide web (about 90%). However, a few face-to-face meetings (about 10%) 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.

Are these programs offered as full time programs?

No, the MS and Certificate programs are offered as part-time programs only.

I have an undergraduate degree in a non-healthcare or non-science area. Can I apply to the RA or CT program?

The RA and CT professions are multi-disciplinary. RA and CT professionals often come with diverse backgrounds. Generally, most have either a science or technical background. RA and CT professionals are often required to understand scientific, engineering, or technical concepts. Yet, RA and CT Professionals also need skills in communication, negotiation, project management, and financial management, to name just a few. 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 or Financial Management).

Are the RA or CT programs self-study or self-paced?

The programs are not self-study, nor done at a self-paced format. Both Certificates and Masters programs operate 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 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.

Can I complete the RA or CT Certificate Program in one semester? Are all Certificate Program courses offered each semester?

No. Generally, one to three classes per semester are offered. Since the RA and CT Certificate Programs consist of multiple courses, you are not able to complete the program in one semester. It may take a minimum of two to three semesters for a given certificate and multiple semesters for the MS Program.

Can I complete the RA or CT Certificate or MS in 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. Students from outside Georgia will be assessed out-of-state fees.

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.

Credit Hours: What are the credit hours for each program path? What is the difference between the RA Certificate, the Masters Programs and the CT Certificate?

a. RA Certificate Program is a total of 14 semester hours (4 courses).

b. CT Certificate Program is a total of 17 semester hours (5 courses).

c. Masters Program is a total of 38 semester hours, 24 or 21 semester hours beyond a certificate program hours:

E.g. 14 RA Certificate hours + 24 Masters Hours = 38 Total Program hours.

E.g. 17 CT Certificate hours + 21 Masters Hours = 38 Total Program hours.

All programs are graduate-level programs. You must have an undergraduate degree from an accredited institution to be considered for admission. Each path has a separate application process.

The Masters Program is a 38+ semester credit hour program offering graduate courses that provide an in depth knowledge of the industries and profession. At the conclusion of this path, the student will possess a Masters of Science in Pharmacy degree with an emphasis in Regulatory Affairs, which includes the Graduate Certificate.

Will the four RA Certificate Program courses be applied to the MS in Regulatory Affairs degree program if I decide to apply?

Yes, the credit hours earned in the RA Certificate Program can be applied to the Masters Program.

Will the six CT Certificate Program courses be applied to the MS in Regulatory Affairs degree program if I decide to apply?

Yes, the credit hours earned in the CT Certificate Program can be applied to the Masters Program.

Transfer credit hours: Is it possible to transfer credit hours for a similar course that I took at another institution?

It is possible to transfer a limited number of credit hours for the Certificate Programs and the Master's Program from another accredited university. The policy, however, is stringent. For the Certificate Programs, a student may only transfer a maximum of 4 credit hours for a comparable class. 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 will need to receive prior approval from the RA Program Director before any credit hours can transfer.

Class Meetings: Where will the face-to-face meetings take place? Do I have to commute to Athens, GA to participate? 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.

Directions to this campus may be found at www.uga.edu/~gwinnett/about/visit.html.

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Applying to the Programs

How do I apply for one of the programs? It is the applicant's responsibility to familiarize her/himself with the application criteria and to meet all noted deadlines. Select the appropriate link to learn about the application process for a given program:

  1. RA Certificate program
  2. CT Certificate program
  3. MS Program in RA

Why do I need to apply to both the UGA Graduate School and the UGA Regulatory Affairs Office when I am interested in only a certificate?

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.

Admission Test: Is there a required admissions test for the certificate programs, like the GRE (Graduate Records Examination)?

For the certificate programs, there is no admissions test required. The GRE is required only for consideration for admission into the MS program.

If I already have a graduate degree, is the GRE (Graduate Records Examination) required for the Masters Program in Regulatory Affairs?

Applicants for the MS Program who already possess a PH.D. or ED.D. degree from a accredited university may petition the academic department for a GRE waiver. 

Professional degrees such as the M.D., D.V.M. and Pharm.D. are not considered equivalent to a doctoral degree and the GRE cannot be waived for those individuals.

What is the application deadline for materials in order to be considered for admission into one of the programs?

Deadlines* for the Regulatory Affairs Certificate and Masters Programs are the same. Our program takes applications on an on-going basis. However, to be admitted for a specific semester, your completed applications 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 15
Spring Semester - November 1

International Applicants
Fall Semester - April 15
Spring Semester - October 15

Applying for the MS Degree Program: How do I apply to the MS Program (a degree-seeking Program)?

Information on applying to the MS Program is found at: www.rx.uga.edu/main/home/reg_affairs/
Masters_Program_Application.htm

Admission Tests: Am I required to take the Graduate Records Examination (the GRE) to apply for admission to MS in Regulatory Affairs?

Yes. GRE testing is required for admission consideration into the MS Program. 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.

The GRE is the required test for consideration for admission into the MS Program. There are no exceptions. No other test scores can be substituted for the GRE. For admission decisions, we require only the Quantitative and Verbal scores of the General Test. The submitted GRE scores must be no more than 5 years old. If older than that, you must retake the test and submit your new scores.

A combined (verbal and quantitative) GRE score of 1000 or higher is preferred. However, 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.

What is the minimum undergraduate GPA required for consideration for admission?

A minimum GPA range for consideration is 2.8- 3.0.

What is the minimum GRE Scores required for consideration for admission to MS in Regulatory Affairs degree program?

The GRE is the required test for consideration for admission into the MS Program. There are no exceptions. No other test scores can be substituted for the GRE. For admission decisions, only the Quantitative and Verbal scores of the General Test are required. The submitted GRE scores must be no more than 5 years old. If older than that, you must retake the test and submit your new scores.

A combined (verbal and quantitative) GRE score of 1000 or higher is preferred. However, GRE scores are assessed in relation to other factors such as GPA, background and personal interview for determination of admission. Applications of all qualified persons with a sincere interest in pharmaceutical and biomedical regulatory affairs are welcome.

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
706-542-3183.

What is the deadline for admission into the Masters Program?

Deadlines for the Reglatory Affairs Certificate and Masters Programs are the same. Applications are accepted on an ongoing basis. However, to be admitted for a specific semester, your completed application must be turned in to the Office of Regulatory Affairs Graduate Education Program 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 will be made only on completed files.

Application Deadlines

Domestic Applicants
Fall Semester - June 15
Spring Semester - November 1

International Applicants
Fall Semester - April 15
Spring Semester - October 15

What is meant by "Continuous Enrollment"? (Applies to MS Students only.)

UGA Graduate School Policy on Continuous Enrollment - Beginning Fall Semester 2007, the Continuous Enrollment Policy of the Graduate School begins. 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). This policy takes effect Fall Semester 2007 for all graduate students except the following:

  1. University employees on the Tuition Assistance Program; and,
  2. Students in non-degree status

As you plan your studies at the University of Georgia, please become familiar with the policy in the Graduate Bulletin at - www.uga.edu/gradschool/academics/registration.html.

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International Applicants

How do international students apply for this program? Deadlines?

In addition to the academic department and UGA Graduate School admission materials, prospective international students are required to provide additional supplemental materials. Please review www.uga.edu/gradschool/admissions/int_supplements.html.

Application Deadlines - Deadlines for international applicants are as follows:

Does this department offer sponsorships for international students?

No. At this time, the Regulatory Affairs Office does not offer sponsorship (various visas or assistantships).

International Students: Do I need to provide TOEFL (Test of English as a Foreign Language) scores for the Certificate Programs? For the Masters Program? Where can I find information on Testing Centers for the TOEFL? What is the minimum score required?

TOEFL scores are required for all programs if you received your last degree from an institution where English is not the primary language. Therefore, 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

How can I find out when or what Regulatory Affairs courses will be taught?

RA Certificate Students may refer to - www.rx.uga.edu/main/home/reg_affairs/certificate_students.htm.

CT Certificate Students may refer to - www.rx.uga.edu/main/home/clinicaltrials/certificate_students.htm

MS Students may refer to - www.rx.uga.edu/main/home/reg_affairs/masters_students.htm

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 OASIS system at oasisweb.uga.edu/. This is an online registration system.

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.

How much does the RA and CT programs cost?

The cost to participate in the program is dependant on your status as either in-state or out-of-state. It is the applicant's responsibility to make him/herself aware of these charges. Always check the Bursar's Office website for the most recent tution costs. The URL is: https://busfin1.busfin.uga.edu/bursar/schedule_fee.cfm. Your overall tuition is broken down as follows:

These costs are subject to change. For more detailed information on the fee structure, visit the UGA Bursar's Office website at: busfin1.busfin.uga.edu/bursar/schedule_fee.cfm

How do I pay for the courses that I take?

At the completion of the registration process through the UGA OASIS 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.

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/deadlines.html. Please review this site for information on when payment for classes is due.

What is the Regulatory Affairs Program Fee?

A program fee for Regulatory Affairs Graduate Education Programs is charged in addition to the standard graduate tuition rate. The program fee is used directly to cover fixed costs and help run day-to-day expenses of the program (i.e., administrative costs, operating costs, delivery, technology, etc). This is necessary since tuition is State money that goes back to the USG Board of Regents for system-wide instruction and allocation, based on credit hour production. The program fee provides needed funds to operate new specialized programs of study, which do not enroll the large number of students required to generate enough credit hours for sufficient state support.

Does the Regulatory Affairs Program Fee apply to the Clinical Trials program?

Yes. All students in the RA, CT and MS programs are required to pay the Regulatory Affairs Program fee.

What is the deadline to register in the RA, CT, Certificate Program courses? Masters 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.

Does the Regulatory Affairs Program offer financial aid?

Federal loans are available to those who are pursuing the Masters degree. All financial aid is handled through the UGA Office's 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 to the Financial Aid Office.

There is no federal financial aid for the Certificate Program.

Can I take a single course without going through the application process?

No. Should you decide to take a single course on a one-time basis for professional development, you will need to apply to the program as a certificate applicant (non-degree seeking) and pay the tuition and program fees.

I am unable to register through the OASIS system. What do I do?

Please see oasisweb.uga.edu/ for technical trouble shooting tips. If your records are "flagged" that too can prevent registration. Flags can occur if you have not submitted your immunization records or have an outstanding fine for an overdue book, as examples. Please make sure you have no flags on your record by contacting the UGA - Gwinnett campus Registrar's Office at 706-542-8772.

Why must I submit proof of immunizations?

The USG Board of Regents requires each entering student to show proof of immunization before he/she is able to register. If requirements are met, the Health Center staff will clear you to proceed with the registration process. The UGA Medical Records Department can be contacted at 706-542-1767, by fax at 706-542-4959, or www.uhs.uga.edu/. Although the Regulatory Affairs program is primarily a distance learning program, immunization records are still required of all students. Failure to comply will result in an inability to register for classes.

How long must I be a resident of the state of Georgia to be considered "in state" for fee assessment purposes?

A student must reside within the State of Georgia for 12 months or more to be considered for in-state tuition.

Why do I have to pay out-of-state fees for a distance learning program?

At the present time, UGA is unable to waive out-of-state fees for students who are not residents of Georgia or an SREB state as our program is regulated by the USG Board of Regents. Tuition is the same for in-class and distance-class graduate programs.

What is FERPA, Family Educational Rights and Privacy Act?

FERPA is a federal law designed to protect the privacy of education records and provides students with certain rights with respect to their education records.

For additional information, please visit: https://infosec.uga.edu/policies/management/ferpa.php

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Distance Learning and Computer Technologies

I have registered to take an RA / CT course. What do I do now? How do I start the course?

A week prior to the start of classes, the Regulatory Affairs Office will send out email announcements to registered students about your class. Contained within this email will be specific instructions on accessing the class, class meetings, and other important information.

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.

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.

What is the method of delivery for these courses?

This program will incorporate many delivery systems. Since this program is geared for the working professional, the primary mode of delivery will be via a web-based delivery system called eLC used by the University of Georgia. The web delivery component is approximately 90 percent. The other 10 percent of coursework will take place face-to-face or via synchronous instruction.

What software and hardware will I need to participate remotely via the World Wide Web?

Currently, minimum software requirements include MS Windows Vista, XP, MS Office 2000 or higher (including Word, Excel & PowerPoint), internet access, an email address, RealOne Player (free) and Adobe Acrobat Reader (free). In addition, the required internet browser is Microsoft Internet Explorer or Mozilla Firefox. Note that appropriate versions of the required browser software change as the web-based course tools software changes. More information is provided after admission to the program. Software upgrades may be necessary during enrollment in the program and students are responsible for assuring these upgrades are employed and that all software is operational. The minimum hardware standard is a computer that will run the listed software with reasonable speed and have a cd-rom drive and audio/video capabilities.

Materials will be transmitted to the student in a format that can be processed by the listed software. The student must transmit materials in a format that can be processed by the listed software.

Will my computer work for this program?

If you have access to a PC that is MS Windows-based and runs an operating system of Win 2000 or above, access to MS Office (Word, Powerpoint, and Excel) and Adobe Reader, with a high speed internet connection, your computer will work for this program.

What kind of internet connection do I need?

A high speed internet connection is highly recommended for this type of program.

To test your browser, go to www.uga.edu/browsertest.

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: www.blackboard.com or http://elc.uga.edu.

During the Program Orientation, the Regulatory Affairs office provides training and instructions on eLC to those students without experience.

I am not familiar with eLC. Is there someone to help me?

Yes. the Regulatory Affairs Office will assist you with eLC questions. At the program orientation, there is a eLC Training Seminar that all students are encouraged attend. In addition, you may contact our administrative offices with additional questions.

During the Program Orientation, the Regulatory Affairs office provides training and instructions on eLC to those students without experience.

I am not familiar with MS Excel (or other applications used in the program) where can I get help?

It is the applicant's responsibility to have a working knowledge of the MS Office programs and other applications. If not, you will need to seek out additional training. If you are accepted into this program, you will have access to an electronic training service via the web. It is called element K.

I am not certain I am cut out for distance learning. How might I assess my motivation and interest in this type of learning?

Included in the Regulatory Affairs website is a distance learning self assessment test. Feel free to take this self assessment. This should give you a good indication of your motivation and interest.

If I am admitted into this program and experience technical issues, what do I do?

When you encounter technical issues, please contact the Regulatory Affairs Office. If the technical problem requires UGA Helpdesk support, the Regulatory Affairs office staff will be able to direct you.

UGA Helpdesk contact is: 706-542-3106 and online at eits.uga.edu/mail-forms/ct.php

Do the Regulatory Affairs Programs participate in the TAP, Tuition Assistance Program, for University System of Georgia Employees?

Yes. The RA programs participates in the TAP program.

The RA Program fee is a part of the overall Regulatory Affairs tuition. Since tuition for these Regulatory Affairs courses is greater than the standard tuition amount, USG institutions may elect to waive only that portion of the tuition that does not exceed the normal tuition amount. An employee will be responsible for paying the remainder of the tuition (program fee) cost.

Participation in TAP is on a space-available basis; therefore, the TAP registration period follows the regular registration period.

All questions related to the TAP program must be directed the applicant's home institute TAP Office.

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