What is Regulatory Science?
Regulatory Science, as defined by the U.S. Food and Drug Administration (FDA), is the development and use of the scientific knowledge, tools, standards, and approaches necessary to assess the safety, efficacy, quality, potency, and performance of medical products and foods. The Institute of Medicine (IOM) emphasized the need for increased training in Regulatory Sciences in their 2011 report, “Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development: Workshop Summary.” Regulatory scientists use their knowledge base in basic research with an applied focus in food, drug, and device development and assessment.
Benefits of the Certificate in Regulatory Sciences
The Graduate Certificate in Regulatory Sciences from the University of Arkansas for Medical Sciences (UAMS) sets you apart for careers involving regulatory assurance of safe products. Program participants learn from experts at UAMS, the private sector, and the US Food and Drug Administration (FDA). Our program serves both full- and part-time students interested in expanding their regulatory science knowledge and skills, and provides critical acumen for regulatory science-based careers. Graduates of the program receive enhanced training that will serve them in jobs in drug development, biotechnology, medical device development, and food safety sectors of government and industry.
What Makes the UAMS Graduate Certificate in Regulatory Sciences Unique?
The Regulatory Sciences program at UAMS was born from long-standing collaborations between UAMS and the FDA’s National Center for Toxicological Research in Jefferson, AR. UAMS faculty and FDA scientists worked in partnership to develop the curriculum for the Graduate Certificate in Regulatory Sciences. Scientists from the private sector and FDA join UAMS faculty to teach the courses in the program. Most of the students who have enrolled in the Graduate Certificate program already possess a graduate degree but still wish to better understand how basic research is applied in the regulatory decision-making process. The UAMS Graduate Certificate program provides these credentials without the cost and time commitment required of a full master’s degree program.
Graduate Certificate Curriculum
The Graduate Certificate comprises four 3-hour courses that will provide the competitive edge you need to launch a successful career in a regulatory agency or in the regulated industries that strive to provide safe and effective products regulated by the FDA. In order to make our program more accessible to career-minded scientists who want to enhance their knowledge in regulatory science, out-of-state tuition is waived for all students in the program, regardless of where they reside, so our new online-only approach gives students both great value and significant flexibility around busy work schedules.
Recommended Course Schedule for Regulatory Sciences Certificate
Full-Time Enrollment Guide for Students Starting Fall Semester
Fall Year 1
REGS 60133: FDA Regulations (3)
REGS 60233: Methods in Risk Assessment and Management (3)
Spring Year 1
REGS 51073: Design and Management of Clinical Trials (3)
REGS 61003: Good Regulatory Practices (3)
The UAMS Regulatory Sciences program is a campus-wide initiative involving the Colleges of Medicine, Pharmacy, and Public Health, offered through the UAMS Graduate School and administered by the Department of Environmental Health Sciences.
To learn more about our Regulatory Sciences program, call Christopher Fettes at 501-526-4260 or email cafettes@uams.edu.