Graduate Certificate in International Biomedical Regulatory Sciences
Graduate Certificate in International Biomedical Regulatory Sciences
I have 20 years of experience in the medical device and pharmaceutical industries, having held executive leadership positions in Quality Assurance, Quality Control, and Regulatory Affairs.
Overview
Due to the rapidly expanding biomedical industries, an increase in the number of Regulatory Sciences professionals is needed to maintain compliance with regulatory policies and procedures for multiple product lines.
Offered through the College of Pharmacy, the University of Georgia’s online Graduate Certificate in International Biomedical Regulatory Sciences provides a foundational core covered in three semesters of coursework that will round out your experiences in regulatory affairs or prepare you to transition into the high-demand field of regulatory sciences.
Specialized and convenient education is crucial for busy professionals to gain and maintain an understanding of the scientific and technical background of new or existing products including regulations for pharmacy compounding and international regulations. The program covers requirements for Pharmaceuticals, Biologics, Medical Devices, Animal Health, International Regulations, and Combination Products.
The online Regulatory Sciences Certificate coursework will prepare you for the RAC Exam, covering about 80% of the RAC Exam material, and can be applied toward the UGA online M.S. in Pharmacy with an emphasis in International Biomedical Regulatory Sciences.
Mission Statement
The Regulatory Sciences Graduate Certificate Program equips students with essential knowledge and skills to navigate through the complex landscape of healthcare product regulations, preparing them for entry-level positions and enhancing their expertise in the ever-evolving field of biomedical regulatory sciences.
Other online programs of interest
You also may be interested in these online programs:
Graduate Certificate in Chemistry, Manufacturing & Controls
Graduate Certificate Clinical Trials Design and Management
Graduate Certificate in Drug Safety and Pharmacovigilance
Master of Science (M.S.) in Pharmacy, Clinical Trials Management
Master of Science (M.S.) in Pharmacy, International Biomedical Regulatory Science
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. The University of Georgia also may offer credentials such as certificates and diplomas at approved degree levels. 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).
Admissions
Credit and Transfer
Total Hours Required to Earn Degree/Certificate: 14 (credit hours)
Maximum Hours Transferable into Program: N/A
Admission Requirements
To apply to the Graduate Certificate in International Biomedical Regulatory Sciences Program, students not currently enrolled at UGA must apply to the UGA Graduate School. An undergraduate degree from an accredited institution is required, and preference will be given to those with degrees in sciences, healthcare, or engineering. Additional preference will be given to applicants employed in the pharmaceutical, medical device, biotechnology industries, or related fields.
Entrance exams are not required but can be submitted.
Follow the detailed Application Checklist below.
Application Checklist
- Application – submit online to the Graduate School Admissions. Application fee: $75 Domestic / $100 International
- Select Campus – Online
- Select Intended Program -CERG, International Biomedical Regulatory Sciences (College of Pharmacy)[CERT_2IBR]
- Résumé or curriculum vita – Upload to the Graduate School application.
- Statement of Purpose – Submit a one-page statement of purpose online to the Graduate School through the application system. Identify your educational goals and expectations for the program. Use this opportunity to explain your knowledge or familiarity with Regulatory Sciences or Clinical Trials. Please ensure that your response reflects your own thoughts and experiences, as the College of Pharmacy values authentic and personal statements.
- Transcripts – Submit unofficial transcripts from all institutions attended as part of the online application. Send official transcripts after you are offered admission.
- Letters of Recommendation – Submit two 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. The application will prompt your recommenders to submit their letters electronically.
International Applicants – must also submit TOEFL or IELTS scores
Application Deadlines
Domestic Applicants
- Fall: June 1
- Spring: November 1
International Applicants
- Fall: April 15
- Spring: October 15
Cost
Tuition & Fees
Tuition rates and student fees may change each year.
Based on the 2024-25 credit-hour cost, a person who had completed this program at the recommended pace would have paid $10,332 in tuition. Reference this sheet to identify the current credit hour rate for your program of interest.
Please use the Estimated Cost Calculator on the Bursar’s Office website to calculate one academic (Fall/Spring) year’s tuition.
This program is an E-Rate program, so choose “yes” for the E-Rate line item within the calculator.
Fees for those students enrolled in exclusively online programs are $411 per semester.
Potential additional costs include:
- Textbooks
- Exam proctoring fees
- Technology upgrades
The complete cost of attendance can be found at https://osfa.uga.edu/costs/.
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).
Technology Requirements
- Computer with current operating system (Windows, Mac, or Linux). Additional peripherals such as webcam, headphones, and microphone are required.
- High-speed internet access.
Curriculum
Program Structure
The program plan is ideal for working professionals and consists of 14 semester credit hours, delivered online, with occasional live sessions at the UGA Gwinnett Campus.
Courses
| Course | Title | Credit |
| PHAR 6010E | Intro to Pharmaceutical, Biotechnology & Device Industries | 4 |
| PHAR 6020E | Food and Drug Law | 3 |
| PHAR 6030E | Current Good Manufacturing Practices | 4 |
| PHRM 7230E | Ethics in Research | 3 |
Faculty
News & Events
UGA pharmacy student develops a passion for regulatory sciences
September 18, 2020Until she began taking regulatory science courses online, Tiffany Somereville was unaware of the significant impact regulatory affairs had on public health. A UGA Doctor of Pharmacy student, Somereville has already earned her Graduate Certificate in International Biomedical Regulatory Sciences and is now also pursuing an M.S.
Growing Labor Market Need for Biomedical Regulatory Sciences
June 25, 2020As technology in medical sciences advances and demand for Regulatory Science professionals in the healthcare industry increases, graduate training capacity for US Regulatory Professionals may be facing a talent crisis. The professionals working in the field of Regulatory Sciences work with FDA and other regulatory authorities…
University of Georgia Represents at the Georgia Bio Summit
October 16, 2019Students and professors from the University of Georgia College of Pharmacy recently attended the Georgia Bio Summit at the Cobb Galleria in Atlanta, Georgia. The Georgia Bio Summit is an annual bioscience and medtech conference welcoming hundreds of CEOs, senior executives, scientists and…
Testimonials
I chose UGA because of its phenomenal pharmacy program. We are ranked amongst the top 25 schools in the nation. My understanding and respect for regulatory affairs has grown tremendously, making my online courses particularly interesting. The courses I’m taking have opened my eyes to new ways that I can help ensure public health and safety.
Tiffany Somereville, ’20
The faculty and staff of UGA’s online programs are welcoming, friendly, available, and willing to do what is necessary to help you succeed. I believe in the human touch and have felt a lifelong obligation to help others in any way possible. I hope to use my abilities to navigate members of the industry through regulatory compliance matters so that most people can receive the most therapeutic relief and the best medical treatment and diagnosis as possible.
John Mayhall, ’21
Contact Information
Contact us using the request for information form or call 706-452-7958.