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Graduate Certificate in International Biomedical Regulatory Sciences

Graduate Certificate in International Biomedical Regulatory Sciences

photo of Alexander Jacks III, instructor in the Graduate Certificate program 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.

Alexander Jacks, III

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.

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).

Other online programs of interest

You also may be interested in these online programs:

Master of Science (M.S.) in Pharmacy, International Biomedical Regulatory Sciences

Graduate Certificate Clinical Trials Design and Management

Graduate Certificate in Drug Safety and Pharmacovigilance

Graduate Certificate in Chemistry, Manufacturing & Controls

Admissions

Credit and Transfer

Total Hours Required to Earn Degree/Certificate:  14 (credit hours)
Maximum Hours Transferable into Program:  N/A

Admission Requirements

Students who are not currently enrolled at UGA should apply to the graduate school for the Graduate Certificate program in International Biomedical Regulatory Sciences and are not required to take entrance exams and submit letters of recommendation. Preference will be given to applicants with a degree in sciences, healthcare, or engineering.  Preference will also be given to applicants employed in the pharmaceutical, medical device, biotechnology industries, or related field.

Applying to the International Biomedical Regulatory Sciences Graduate Education Certificate Program is a two-step process. You will need to submit our departmental application and an application to the UGA Graduate School.

 Application Checklist

  1. Application – submit online to the Graduate School Admissions. Application fee: $75 Domestic/$100 International
  2. Select Campus – Online 
  3. Select Intended Program -CERG, International Biomedical Regulatory Sciences (College of Pharmacy)[CERT_2IBR]
  4. Submit the Supplemental Application – Certificate in International Biomedical Regulatory Sciences Application (pdf) Complete and email to regsciences@uga.edu or mail to the department: The University of Georgia Gwinnett Campus International Biomedical Regulatory Sciences 2530 Sever Road Lawrenceville, Georgia 30043-4005
  5. Résumé or curriculum vita – Upload to the Graduate School application.
  6. Statement of Purpose – Submit to the Graduate School online in your application  
  7. Transcripts – Submit unofficial transcripts from all institutions attended as part of the online application. Send official transcripts after you are offered admission. 
  8. 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 can change each year. 

Based on 2022 credit hour cost, a person completing this program at the recommended pace would have paid $10,080 in tuition.  

Please use the Estimated Cost Calculator on the Bursar’s Office website to calculate one academic (Fall/Spring) year’s current tuition. 

This program is an E-Rate program, so choose “yes” for the E-Rate line item within the calculator.

Online students pay the following fees: Connect UGA, Green, and Technology. The total for those fees in the fall semester of 2022 was $147 for students enrolled in exclusively online courses. 

Potential additional costs include textbooks, exam proctoring fees, and 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

CourseTitleCredit
PHAR 6010EIntro to Pharmaceutical, Biotechnology & Device Industries4
PHAR 6020EFood and Drug Law3
PHAR 6030ECurrent Good Manufacturing Practices4
PHRM 7230EEthics in Research3

Faculty

News & Events

UGA pharmacy student develops a passion for regulatory sciences

September 18, 2020

Until 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, 2020

As 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, 2019

Students 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…

See more news articles related to this program

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.

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