George Washington University Offers Regulatory Affairs Graduate Program

Just last May, five of the very first students in George Washington University’s (GW) brand new regulatory affairs graduate program graduated with an M.S.H.S., or Master of Science in Health Sciences. The program, which is housed under the university’s School of Medicine and Health Sciences, was founded in 2010 with the goal of preparing students and professionals in the health sciences industry to tackle the global regulatory landscape.

The program’s global focus is what makes it unique among comparable programs nationwide, program director Daniela Drago, Ph.D., told Medical Product Outsourcing.

“Other programs typically have an international regulatory affairs course as an elective, but a lot of the U.S. programs are U.S.-centric, and a lot of the European programs are EU-centric,” Drago explained. “We integrate global regulatory strategies in each and every course that we offer. I strongly believe this is a huge advantage because it gives the opportunity for students to understand global interconnections, widen their horizons, and increase their marketability in today’s markets. Many companies are looking for professionals who can manage and lead international and global teams.”

Drago, a chemist by training, is director of GW’s regulatory affairs program, and was recruited from the pharmaceutical industry in her second home Switzerland (she is native to Italy). In considering the next step in her career, she said, teaching was the most appealing option in that it is fulfilling and requires the exact skill set that she spent years acquiring in an academic setting as well as in industry. Industry experience is vital to the instruction offered by GW’s program; in fact, Drago is the only full time faculty member in the program for regulatory affairs. All other faculty are actively involved in industry in some way.

“The dual role of Regulatory Affairs immediately fascinated me,” said Drago, explaining her involvement with the regulation side of medtech. “You are both a ‘gatekeeper’ and an ‘enabler.’ As a gatekeeper you address compliance, and as an enabler you strategize and facilitate bringing new products to the market.

“Our faculty membership is comprised of regulatory affairs professionals who work in industry, at the FDA [U.S. Food and Drug Administration] and/or serve in leadership and consultancy roles,” Drago continued. “We also employ a number of accomplished global regulatory professionals who give guest lectures throughout our curriculum. We have recently formed an advisory board. Global senior leaders from the drug and device industry and former FDA officials have joined. The board will advice on our strategic direction and create networks for students and graduates. Insights from the board members will ensure that the curriculum incorporates skills that meet current needs in the field.

“The program is rapidly acquiring its profile among employers. Students and graduates move easily into jobs,” added Drago, explaining that this distance education program is highly interactive, flexible and challenging.

Students attracted to the program, which can culminate either in the master’s degree or a certificate, come from all backgrounds. The majority of students come from science and engineering; others have a healthcare background, such as nursing. All students come to the program because they seek an edge in the job market, whether they be just starting out or already established in their career and seeking upward mobility.

Students with a STEM background—that is, science, technology, engineering and math—will be much in demand in the coming years, Drago said.

“It’s becoming more and more obvious that careers in medtech or healthcare are careers in a growing field, and can be exciting, providing a lot of opportunities,” Drago said. “STEM programs do have a pivotal role—they really help students to become highly sought after professionals. If students are acquainted with STEM, they often have an extra gear in today’s economy which is increasingly technology based.”

Because of GW’s location in Washington D.C., just about 10 miles from the FDA headquarters in Silver Spring, Md., the regulatory affairs program enjoys a productive relationship with the federal regulatory body that is beneficial to the students. According to Drago, the university “tries to engage the agency in different capacities” including having FDA officers guest lecture or even teach entire courses. In fact, the FDA was instrumental in founding the program, the seeds of which were sown in 2008.

“At that time GW had discussions with FDA and leaders from the healthcare industry: those working with medical devices, in vitro diagnostics, drugs and biologics,” said Drago. “The idea was to identify the core competencies of the new regulatory leaders of 2020.”

Other universities that offer similar master’s degrees are Northeastern University in Boston, Mass.; Hopkins University, Baltimore, Md.; University of Southern California, Los Angeles, Ca.; Arizona State University, Phoenix, Az.; Temple University, Philadelphia, Pa.; St. Cloud State University in St. Cloud, Minn.; and Purdue University in West Lafayette, Ind.