Overview

M.S. in Pharmacy, International Biomedical Regulatory Sciences

The rapid expansion of pharmaceutical and biomedical products requires a greater number of highly skilled Regulatory Sciences professionals to oversee the approval for new product lines and manage compliance with complex regulatory policies and procedures. Specialized and convenient education is crucial for busy professionals to develop and sustain an understanding of the ever-changing regulatory environment.

The online M.S. in International Biomedical Regulatory Sciences, offered through the UGA College of Pharmacy, assures a strong professional background needed to succeed in administrative positions and specialized areas required of the hands-on profession. Regulatory affairs professionals are multi-disciplinary. UGA offers the only online regulatory sciences master's in the U.S. that covers requirements in both the medical and veterinary industries. With the choice of either a thesis or non-thesis path to the degree, this program is ideal for individuals who have a clear objective to cultivate a career in regulatory affairs, and for those with an industry background desiring an advanced education in regulatory management. The courses cover regulatory requirements for Pharmaceutical, Biologic, Medical Device, Animal Health, International Regulations, and Combination Product as well as the management and monitoring of clinical trials.

  •     Pharmaceuticals
  •     Biologics
  •     Medical Devices
  •     Veterinary Products
  •     Combination Products
  •     International Regulations

Download the complete Regulatory Sciences program brochure (PDF)

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

You also may be interested in these certificate programs:
Graduate Certificate Clinical Trials Design and Management

Graduate Certificate International Biomedical Regulatory Sciences

Accreditations

The University of Georgia is accredited by the Southern Association of Colleges and Schools Commission on Colleges (SACSCOC) to award baccalaureate, master’s, specialist, and doctoral degrees. Questions about the accreditation of the University of Georgia may be directed in writing to the Southern Association of Colleges and Schools Commission on Colleges at 1866 Southern Lane, Decatur, GA 30033-4097, by calling (404) 679-4500, or by using information available on SACSCOC’s website (www.sacscoc.org).

College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education (ACPE).

Technology Requirements

  • Computer with current operating system (Windows, Mac, or Linux). Additional peripherals such as webcam, headphones, and printer may be required.
  • High-speed internet access.
  • Free software required for UGA students –Microsoft Office, Adobe Reader, Flash, Firefox and Chrome browsers, Zoom

Cost

Tuition & Fees

Online Tuition $720 per credit hour 38 credit hours $27,360 USD
Student Fees $597 per semester 6 semesters $3,582 USD
Total Program Cost     $30,942 USD

Tuition and fees are subject to change. Visit the Bursar's Office website to view current tuition and fees. If you register for less than 5 credit hours, student fees are reduced to $372 in that semester.

Online students pay the following fees: Connect UGA, Green, Special Institutional, and Technology. See UGA Tuition and Fees for the complete schedule of fees.

Additional costs may include textbooks, exam proctoring fees, and technology upgrades.

Financial Aid

Visit the Office of Student Financial Aid for information about financial assistance.

Corporate Assistance

Consult your employer about the availability of tuition reimbursement or tuition assistance programs.

Military Assistance

Active duty military, veterans, and military families should visit Veterans Educational Benefits to take full advantage of available financial assistance and educational benefits.

University System of Georgia Tuition Assistance Program (TAP)

The purpose of TAP is to foster the professional growth and development of eligible employees. For more information, see Tuition Assistance (refer to the Distance Learning section). 

Admissions

Credit and Transfer

Total Hours Required to Earn Degree:  38 - 39 (credit hours)

Maximum Hours Transferable into Program:  6

A maximum of 6 credits may be transferred into the program with Director's approval. The International Biomedical Regulatory Sciences Graduate Education Program is a member of the Atlanta Regional Council for Higher Education (ARCHE), which allows students to register for approved courses at an approved ARCHE member institution.

Admission Requirements

Students applying to the University of Georgia must be accepted by the Graduate School. Any student holding a bachelor's degree from an institution accredited by the proper regional accrediting association is eligible to apply. Preference will be given to applicants with a degree in the sciences, healthcare, or engineering. Preference will also be given to applicants employed in the pharmaceutical, medical device, and biotechnology industries or a related field.

  1. Application – Submit the Graduate School Admissions online.  Application fee: $75 Domestic/$100 International.
  2. Select Campus - Online
  3. Select Intended Program - MS, Pharmacy (College of Pharmacy)[MS_PHRM_GWON]
  4. Select Area of Emphasis - Pharmaceutical and Biomedical Regulatory Affairs 
  5. Submit the Supplemental application - Complete the M.S. International Biomedical Regulatory Sciences Supplemental Application and email it to regsciences@uga.edu, or mail to the address on the form.
  6. International applicants must submit TOEFL or IELTS scores.
  7. Résumé or curriculum vita – Upload to the Graduate School application.
  8. Statement of Purpose – Submit a one-page statement of purpose online to the Graduate School. The statement of intent should clarify the candidate's relevant background, interests, and goals in relation to the program.
  9. Transcripts – Submit unofficial transcripts from all institutions attended as part of the Graduate School application. Send official transcripts after you are offered admission.
  10. Letters of Recommendation – Submit three letters of recommendation online to graduate school. Letters should be from individuals who can evaluate the applicant’s scholarly ability and potential for success in a graduate program. Preferably at least two of them are from faculty who have instructed the applicant in a previous program of study. The application will prompt your recommenders to submit their letters electronically.
  11. Professional or Academic Writing Sample: 
  • Not to exceed 5 pages
  • On a regulatory sciences topic of your choice
  • This sample helps the department to evaluate your writing skills and determine your communication style. Be sure that your writing sample is grammatically correct and free of typographical errors and misspellings. Send the writing sample to the department along with your Personal Profile.

Interview with Department:  Schedule your interview with the department and ensure that it takes place PRIOR to the application deadline.

Choose either the Thesis or Project model and make note of the proper program code in your UGA Graduate School application.

  • MS_PHRM_GWON: Masters of Science Thesis option
  • MS_PHRM_GONT: Masters of Science Project option

Additional Application Information:

  • A Bachelor’s degree (or higher) is required. Preference will be given if an applicant’s degree is in sciences, healthcare, or engineering.
  • The minimum undergraduate GPA standard for admission to the Graduate School at the University of Georgia for applicants who do not have a prior graduate degree is 3.0.
  • Preference will be given if an applicant is employed in the healthcare, pharmaceutical, medical device, biotechnology industries, or related field.
  • Applicants are encouraged to include a company support letter in their application documents
  • You will need daily access to a computer with required specifications and a working knowledge of the Microsoft Windows Operating System, Microsoft Office Suite (including MS Word, PowerPoint, Excel) Internet Explorer or Mozilla Firefox and Adobe Reader.
  • The departmental deadline takes precedence over the UGA Graduate School Deadline. Review the Application Deadlines page for additional information.
  • Only completed applications will be considered.
  • Applicants are responsible for ensuring all documents are received by the noted deadlines.
  • Applicants may track their status by accessing the UGA Graduate School online tracking system at – gradstatus.uga.edu.
  • Once a decision has been made on your application, you will be contacted by the UGA Graduate School.
  • To find out if you are a good candidate for online learning, review the Distance Learning Self-assessment.

International Applicants:

  • Because we are a distance learning web-based program only, all international students, if admitted, are able to participate in our program from their home countries.   Thus, the department does NOT offer student visa sponsorships.
  • The Regulatory Sciences academic program is a part-time only program offering one to two courses a semester for students. There is no full-time academic option.
  • Our program does not offer teaching or financial assistantships or stipends of any sort.

Application Deadlines

Domestic Applicants

  • Fall:  June 1
  • Spring: November 1

International Applicants

  • Fall:  April 15
  • Spring: October 15

Applications submitted after the application deadlines will be marked for the following semester. We will only consider completed applications.

There are no new admissions for summer semesters.

Click here to access the UGA Calendar system, including the Academic Calendars, Registration Calendars, Payment Dates, and Final Exam dates.

 

 

Curriculum

The M.S. in Pharmacy—International Biomedical Regulatory Sciences curriculum covers requirements for pharmaceutical, biologic, medical device, animal health, international regulations, and combination products. Regulatory science 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.

This masters program is a part-time only program and operates on a traditional academic calendar. The first day of class is generally a live session at the UGA Gwinett Campus.  All students are expected to attend the Program Orientation. 

Students may choose either the non-thesis or thesis path to degree completion.

Non-thesis Path 

The non‐thesis pathway will engage you in real‐world application, practice, development, and experiential learning needed for career success. These practical aspects of the job are highly desired by employers and the non‐thesis pathway is particularly suitable for students who do not plan to pursue research intensive positions or complete a Ph.D.

The non-thesis path requires a minimum of 39 semester hours and includes an applied project or internship and a comprehensive examination.

Thesis Path 

Completing a master's thesis demonstrates research competencies, involves direct research experience, and strengthens ones potential application to Ph.D. programs. A thesis may be especially valuable for work requiring research in cutting‐edge development companies.

This path requires a minimum of 38 semester hours and includes the development and oral defense of a research-based thesis. 

Download the PDF explaining the difference between thesis and non-thesis options.

International Biomedical Regulatory Sciences Courses

Sample Part-time Schedule for a Single Academic Term

  Fall Term Spring Term Summer Term

Sample Year (part-time schedule)

  • PHAR 6100: Quality Assurance & Quality Control
  • PHAR 6200: Clinical Trials & Monitoring
  • PHAR 6800: Applied Project
  • PHAR 6130: FDA Submissions
  • PHAR 7100: Biostatistics
  • PHAR 6210: Project Management for Clinical Trials

MS in Regulatory Affairs Program Plan

38-39 total semester hours (Thesis and Non-Thesis (Project) options)

Course topics include the 14 semester hours in the RS Certificate Program:

Core Courses (22 semester hours)

Completion of 14 semester hours (RS Certificate Program courses)

PHAR 6010 Pharmaceutical, Biotechnology, and Device Industries (4 sem hrs)
PHAR 6020 Food and Drug Law (3 sem hrs)
PHAR 6030 Current Good Manufacturing Practices (4 sem hrs)
PHRM 7230 Ethical Issues in Research (3 sem hrs)

Additional Core Courses (minimum of 8 semester hours)

PHAR 6100 Quality Control and Quality Assurance (3 sem hrs)
PHAR 6120 Process Control and Validation (3 sem hrs)
PHAR 6130 FDA Applications and Submissions (4 sem hrs)
BIOS 7100 Biostatistical Applications for Pharmaceutical & Biotech Industries (3 sem hrs)
Master’s Thesis or Major Project

Advanced Electives (minimum of 6 semester hours)

Research Regulatory Affairs
Quality Control and Quality Assurance
Internship in Regulatory Affairs (3 sem hrs)
Clinical Trials Design & Monitoring
Clinical Trials Project Management (3 sem hrs)
Developing Leadership Skills
Drug Development
Veterinary Products

Thesis Track (6 semester hours)

The master's thesis is either a basic or applied research project conducted by the student and supervised by the student's advisory committee. A final oral examination is required.
PHRM 7000 Masters Research (3 sem hrs)
PHRM 7300 Masters Thesis (3 sem hrs)

Non-thesis Track (9 semester hours)

Students pursuing the non‐thesis track must complete and receive committee approval of a focused area of study/exploration and pass a comprehensive written examination, administered by the student’s graduate advisory committee.
Additional elective(s) or other appropriate courses related to the student’s career objective (3 sem hrs).

Applied project and/or internship related to the student’s career objective (3 hrs)
PHAR 6800 Applied Project in Regulatory Affairs
AND/OR
PHAR 6900 Internship in Biomedical Regulatory Affairs
Masters Seminar in Regulatory Affairs (3 sem hrs)

 

Contact Information

Contact the online International Biomedical Regulatory Sciences Coordinator for answers to any additional questions you may have.

Email us using the request for information form or call 1 (706) 452-7948

Testimonials

Testimonials

"I chose UGA because of its phenomenal pharmacy program. We are ranked amongst the top 25 schools in the nation. I am loving how this program has really opened my mind to the breadth of work that regulatory affairs professionals do and how their diligence truly protects the American public health every day." - Tiffany Sommerville, '20


"Being able to work on my degree online has been a major factor that has allowed me to enroll in this program since I work full time. The online learning system is easy to use and I really appreciate the different tools available for lectures and online class meetings.  Being able to effectively work independently and manage my time has been key in getting the most out of the online program." - Cassie Alexander, '19