New MS in Regulatory Science Program Welcomes Inaugural Class

New part-time, online graduate program designed for working professionals focuses on drug product development and regulation.

By Malissa Carroll
February 4, 2014

The University of Maryland School of Pharmacy welcomed the inaugural class of its new part-time, exclusively online Master of Science (MS) in Regulatory Science program on Jan. 27. With its emphasis on drug discovery, drug development, clinical research, and post-approval drug regulation, the program was designed to provide professionals who currently work, or would like to work, in regulatory science with the knowledge and skills necessary to contribute to drug regulation and pharmaceutical product lifestyles.

“Prominent organizations such as the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have articulated a strong need for scientists with backgrounds in regulatory science for years,” says Andrew Coop, PhD, professor and chair of the Department of Pharmaceutical Sciences (PSC) at the School of Pharmacy. “With the creation of the University of Maryland Center for Excellence in Regulatory Science and Innovation, our School has become a national leader in regulatory science research. Our new MS in Regulatory Science program will further enhance our ongoing work in this field.”

Directed by James Polli, PhD, the Shangraw/Noxell Endowed Chair in Industrial Pharmacy and Pharmaceutics in PSC, the program offers a science-driven approach to drug product development and regulation. Its inaugural class includes 32 students who average eight years working in a number of roles related to chemistry/manufacturing/controls (CMC), clinical research, and post-marketing safety.

“There is a vital need 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 new drug products and medical devices,” says Polli. “These individuals play critical roles across academia, government, and industry, but are typically trained in programs that do not include regulatory science education. Our goal was simple – to establish one of the most useful graduate programs in regulatory science, without borders. We have been truly overwhelmed by the incredible support that this program has received.”

Because the program is hosted exclusively online, it attracted professionals from across the state of Maryland, including five alumni of the School of Pharmacy, as well as regions beyond, with two professionals currently residing in Nigeria and Malaysia.

“As someone who has worked in regulatory science since 2000, I have had to learn on the job like many other professionals in the field,” says Aziza Ahmed, MSc, senior manager of APAC Regional Regulatory Affairs at Baxter Healthcare in Malaysia. “As a result, my expertise is somewhat restricted. I am excited to return to school after a 14-year hiatus, and hope to broaden my skillset and interact with other professionals through my participation in the School of Pharmacy’s MS in Regulatory Science program. I also hope that the program will give me a fresher perspective that I can apply to my work.”

Twelve members of the program’s inaugural class are currently employed at the FDA, the federal agency responsible for protecting the public health by assuring the safety, effectiveness, quality, and security of all drugs, vaccines, and other biological products, as well as medical devices.

“I am confident that the MS in Regulatory Science program will provide the additional knowledge and expertise that I need to further my regulatory and scientific career,” says Commander Melina Griffis, BSP ’93, RPh, senior supervisory regulatory review officer in the Center for Drug Evaluation and Research at the FDA. “I am looking forward to learning new information that I can apply to my current role at the FDA, and hope to have valuable interactions with other professionals, as well as my professors.”

The program’s advanced courses in CMC, clinical research, pharmacovigilance, and pharmacoepidemiology attracted a significant number of industry professionals. Several of its lectures are presented by regulatory science leaders from the pharmaceutical industry and FDA, including a number of lectures delivered by alumni of the School of Pharmacy’s Doctor of Pharmacy (PharmD) program and graduate programs in pharmaceutical sciences and pharmaceutical health services research.

“After assuming a new role in quality engineering at my company, I realized that there was so much to learn about the steps required to take a drug from development to a licensed, commercial product,” says Tracy McCarroll, quality engineer at Biogen Idec in North Carolina. “Because I only have six years of work experience, it was really important for me to be able to continue working and gaining experience on the job while taking classes. I am really excited to be a member of the inaugural class of the School of Pharmacy’s MS in Regulatory program, and am looking forward to creating a solid foundation in the field that I can build on with real life experience.”

Emmanuel Ramos, associate manager at Macrogenics, Inc., adds, “Having worked in the pharmaceutical and biotechnology industry for more than 10 years, I believe that receiving formal training in regulatory science will help me further advance my career. The MS in Regulatory Science program at the School of Pharmacy will give me the knowledge and skills that I need to better articulate regulations and apply them to real world situations.”

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 and NIH, the Department of Defense, and the Centers for Disease Control and Prevention; and admission into related doctoral programs.

The next application deadline for this program is June 30, 2014. Current professionals with Bachelor of Science (BS) degrees or higher who now work or would like to work in regulatory science are encouraged to apply. Visit the program’s website to learn more about its admission requirements.

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