School of Pharmacy Launches New Regulatory Science Graduate Program
Available exclusively online, the new MS in Regulatory Science program prepares students to meet the increasing demand for skilled regulatory scientists in academia, government, and industry.
By Malissa Carroll
March 11, 2013
The University of Maryland School of Pharmacy has established a new Master of Science (MS) in Regulatory Science to provide students with the knowledge and skills necessary to contribute to drug regulation and pharmaceutical product lifecycles. With an emphasis on drug discovery, drug development, clinical research, and post-approval drug regulation, this part-time, non-thesis program is designed for working professionals who currently work, or would like to work, in regulatory science.
“The development of our new regulatory science master’s program is extremely timely because of the need to create a regulatory science workforce focused on the dynamic changes in the development and evaluation of new therapeutics,” said Natalie D. Eddington, PhD, FAAPS, FCP, professor and dean of the School of Pharmacy. “Through our program and the expertise of School of Pharmacy faculty, we will generate professionals with the skills and knowledge required to help the pharmaceutical and biotechnology industries put forth successful new drug portfolios that will ultimately improve patient health.”
According to the Food and Drug Administration (FDA), new drugs, biologics, and medical devices have become increasingly complex in their development, manufacture, and evaluation. A vital need exists for qualified regulatory scientists with the knowledge and skills to develop new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of these products. However, while regulatory scientists play critical roles across academia, government, and industry, they are typically trained in programs that do not include regulatory science education.
Directed by James Polli, PhD, the Shangraw/Noxell Endowed Chair in Industrial Pharmaceutics in the Department of Pharmaceutical Sciences at the School of Pharmacy, the MS in Regulatory Science program features a science-driven approach to drug product development and regulation. The program includes courses on chemistry/manufacturing/controls (CMC), clinical research, pharmacovigilance, and pharmacoepidemiology and offers insight on how regulatory principles are applied worldwide.
“For years, individuals working within prominent organizations such as the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have articulated the specific need for scientists with backgrounds in regulatory science,” says Polli. “With the recent creation of the University of Maryland Center for Excellence in Regulatory Science and Innovation, our School has proven itself to be a national leader in regulatory science research. This newly established MS in Regulatory Science program will benefit from, as well as enhance, our ongoing work in this field.”
The program includes five courses that are each worth six credits. All courses are taught by faculty members with expertise in regulatory science and conducted online using a combination of pre-recorded lectures, web conferencing, and online active-learning instruction.
Once students have successfully completed the program, they will be well-trained for a wide range of opportunities in drug research and development, including regulatory science positions in pharmaceutical companies, as well as device and biotechnology companies; regulatory science positions in government agencies, including the FDA, the NIH, the Department of Defense, and the Centers for Disease Control and Prevention; admission into related doctoral programs at the University of Maryland and elsewhere; and admission to professional programs, including pharmacy, medicine, and dentistry.
The application deadline for this program is December 1, 2013. Individuals who have earned an undergraduate degree in science, health or policy, engineering, or business from an accredited US or international institution are encouraged to apply.
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