Mastering Regulations in Research

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What inspired your interest in the field of regulatory science?

My experience as a clinical research pro­fessional greatly influenced my interest in regulatory science. With a background in human subjects protections and experience working on Phase II-IV drug studies, I devel­oped an appreciation for how regulatory science impacts the development of new treatment options. Research at all development stages requires proper oversight, design, and management to ensure risks are minimized and benefits are maximized, all while working to bring new treatment options to the market in a timely fashion. This is a daunting task that relies heavily on the conceptions of regulatory science. With an MS in Regulatory Science from the University of Maryland School of Pharmacy, I hope to bridge my interest in human subjects research with areas of regulatory science to ultimately improve protections for subjects and patients.

What interested you most about the MS in Regulatory Science program at the University of Maryland School of Pharmacy?

I came from a social behavioral background with my first graduate degree in applied psychological research. As I progressed in my career, I found myself in a predominantly biomedical setting working on clinical drug studies and felt I needed to expand my understanding of regulatory science to really grow in my chosen career. The courses offered in this master’s program were a perfect complement to my experience and previous academic work. The program covers drug development from the preclinical stages to clinical trials, and even postapproval. The program also appealed to me because it would allow me to expand my knowledge in areas of drug development and regulation, while still being able to work full time in the field. Having worked predominantly on studies in the clinical trial phases, I often wondered how we got to this point—what came before the clinical trial, and what will come after. This program has allowed me to bridge those gaps and better appreciate the process, as well as to apply what I learned to my daily work.

What are your thoughts about the coursework offered through the program?

I have really enjoyed the coursework and, in particular, the lectures, which are presented by top experts in the field, including individuals in academia, industry, and government, who provide a wealth of knowledge. Having such experts as lecturers is, without a doubt, one of the program’s major strengths. The program is also clearly designed with the working professional in mind, allowing access to lectures and course materials over several weeks. The coursework truly enabled me to explore areas of regulatory science in which I had very little knowledge before starting the program, and the lectures often piqued my interest in areas that I never would have even considered previously. The group projects also offered a valuable opportunity for me to learn from other professionals in the field.

Applications for the Fall 2016 semester are due July 15. Visit www.pharmacy.umaryland.edu/regulatoryscience to learn more.

Jessica Rowe, MA, CCRP, is a student in the University of Maryland School of Pharmacy’s MS in Regulatory Science Program and a research quality improvement specialist in the Office of Research and Scholarship at the University of Maryland School of Nursing.

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