Graduate Certificate in Biopharmaceutical Regulations
Graduate Certificate in Biopharmaceutical Regulations
Teaching gives me an opportunity to share lessons learned from more than 30 years in the pharmaceutical and biotechnology industry.
Overview
The Graduate Certificate in Biopharmaceutical Regulations allows students to gain specialized knowledge and regulatory expertise for working in this area of the medical products industry. The biopharmaceutical industry is expected to continue its robust long-term growth, with some reports projecting 7% growth by 2032, far exceeding the average for all occupations. Developing and offering this graduate certificate will support the workforce development needs in this sector. The certificate curriculum will require a total of 18 credit hours and will cover an overview of regulatory requirements for medical products and bioethics for research and development of medical products, good clinical and manufacturing practices, and biopharmaceutical regulatory science. The students receiving the Graduate Certificate in Biopharmaceutical Regulations will be knowledgeable in the life cycle of medical products from development to post-marketing, which are essential skills for workforce preparedness for professionals in the field.
Roles and Responsibilities of a Biopharmaceutical/Biologics Regulatory Professional:
- Manage all aspects related to biopharmaceutical/biologics safety as members of product development project teams.
- Manage all aspects of pharmacovigilance as members of commercial product stewardship teams
- Liaise with regulatory authorities to communicate and negotiate study protocols and label language related to safety
- Support management in due diligence and strategic business activities
- Work with IRBs and data monitoring boards
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).
Admissions
Online Graduate Certificate in Biopharmaceutical Regulations Application Checklist
- Application – Submit the Graduate School Admissions online. Application fee: $75.
- Select Campus – Online
- Select Degree Level – Certificate
- Select Intended Program – (NEED STEPS FROM APPLICATION SYSTEM)
- Select Intended Term – Fall or Spring
- Résumé or curriculum vitae – Submit online to the Graduate School.
- Statement of Purpose – Submit a one-to two-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.
- 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
Application Deadlines
Domestic Applicants
Fall: June 1
Spring: November 11
International Applicants
Fall: April 15
Spring: October 15
Cost
Tuition rates and student fees can change each year. (eRate Requested)
Based on 2025 credit hour cost, a person completing this program at the recommended pace would have paid $ 13,680 in tuition. Waiting on erate approval
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 $431 per semester.
Potential additional costs include:
- Textbooks
- Exam proctoring fees
- Technology upgrades
The complete cost of attendance can be found at the Office of Student Financial Aid.
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).
Curriculum
18 semester hours to earn the Graduate Certificate in Medical Device and Technologies Regulations
| Course | Title | Credit Hours |
|---|---|---|
| PHAR 6010E | Pharmaceutical, Biotechnology, and Device Industries | 4 |
| PHAR 6030E | Current Good Manufacturing Practices | 4 |
| PHAR 6170E | Biopharmaceutical Regulatory Science | 4 |
| PHAR 6310E | Good Clinical Practice Regulations for Drugs, Biologic Products, and Medical Devices | 3 |
| PHRM 7230E | Ethical Issues in Research | 3 |
Faculty
News & Events
No news articles found
Contact Information
Contact us using the request for information form or call .