A love of complexity. An attention to detail. An ability to think critically and communicate clearly. And underlying all this, a desire to advance and improve human health.
These are some of the qualities required for a career in the intellectually demanding, but ultimately rewarding, field of regulatory affairs.
In the fall of 2017, Georgetown University’s School of Continuing Studies will welcome the inaugural class of its Master of Professional Studies in Regulatory Affairs. The program takes a comprehensive approach to this expanding field, examining regulatory affairs from scientific, ethical, business, and policy perspectives.
“The program will enable students to explore a broad spectrum of regulatory roles,” said Dr. Robert Bienvenu, Faculty Director and Associate Professor of the Practice for the program. “It allows them to focus on a variety of different areas that are relevant to the field.”
Working with expert practitioners, students will develop a deep understanding of the medical product lifecycle and explore strategies for managing everything from pre-clinical research, to clinical trials involving humans, product approval by regulatory bodies such as the U.S. Food and Drug Administration (FDA), and post-marketing activities such as safety monitoring.
Full- or Part-Time Study
Georgetown’s 36-credit program is open to both full- and part-time students. Full-time students can earn a master’s degree in two years, and part-time students have a five-year period to complete the program.
While some students will already be working in regulatory affairs, Bienvenu said, others will come to the program with a variety of work and academic experiences. Regardless of their backgrounds, Georgetown students will follow a systematic path that prepares them for a broad range of careers in regulatory affairs. Students may work on the industry side, in areas such as clinical research trials or preparing medical product applications to the FDA, or on the regulatory agency side, in areas such as policy development, oversight of human subjects research, or review of new drug applications.
The profession is becoming increasingly important because of the accelerating pace of development in technology and medicine.
“We live in an environment where advances in science and technology are outpacing the speed of regulatory change,” Bienvenu said.
Also addressed in Georgetown’s program is strategic planning and thinking. Regulatory professionals are allocating more time “to regulatory strategy, intelligence, and operations,” a recent report from the Regulatory Affairs Professionals Society (RAPS) has noted. In today’s environment, regulatory professionals must be fluent and confident in addressing complex situations and facilitating pathways to successful development of scientific products and discoveries.
A Strong Integration of Ethics and Values
The FDA’s Office of Regulatory Affairs defines its vision as ensuring that “all food is safe, all medical products are safe and effective, and the public health is advanced and protected.” It is a foundational goal that is far easier to define than put into practice in a complex, competitive, ever-changing environment. Georgetown believes that to achieve this, regulatory professionals should be motivated by something deeper than simply mastering the profession’s protocols.
Ethics is a component of all master’s programs at SCS, but its relevance to regulatory affairs—with its focus on human subjects research and medical product development—is especially strong. Ethics is also infused throughout the curriculum by Georgetown’s Jesuit values, which emphasize “care of the whole person” (cura personalis) and “men and women for others.”
“Students will be challenged to think carefully and deeply about the ethical and moral implications of their work,” Bienvenu said, so that people who are healthy remain healthy.”