Northeastern University’s MS Regulatory Affairs team sent four people from our home campus in Boston to the national Regulatory Affairs Professional Society (RAPS) conference, which was held this year in Seattle, including Senior Assistant Dean and Director of MS Regulatory Affairs Eric Kupferberg and Faculty Member Steve Amato. RAPS was well attended this year and we made numerous connections with not just potential students but also future instructors and co-op providers. In addition to the conference the regulatory affairs department hosted a reception at the WBBA facility in Seattle announcing Northeastern’s presence in the area. We also took part in the annual Regulatory Educators Summit where educators from around the country discussed their experience in the growing field of regulatory affairs education. We look forward to next year’s conference back in Boston!
The Regulatory Affairs program within the College of Professional Studies at Northeastern University began with 13 courses in 2004; the program has expanded to 43 courses, each touching on a critical aspect of the field. The core of the program is based on the central regulatory challenges of drugs, medical devices, and biologics, with additional emphasis on clinical trial ethics and conduct as well as the legal decisions that are constantly being revised by the U.S. Food and Drug Administration (FDA) and other regulatory bodies. In addition, the program has developed over thirty elective courses focusing on the advanced aspects of regulatory work.
The program derives its inspiration for new courses from several sources, including: review of new FDA guidelines and rulings; legal actions and court challenges; industry product trends; industry expert suggestions; global regulatory developments; and, examples of increasing market importance of emerging economies. In response to the identified need for more business/marketing-oriented regulators, the program introduced a category of courses which deal with the marketing, strategic business, and project management needs of the field. In conjunction with developing regulations governed by the European Union (EU), China’s State Food and Drug Administration (SFDA), India’s Central Drugs Standard Control Organisation (CDSCO [DCGI]), Brazil’s National Health Surveillance Agency (ANVISA), Australia, Japan, Canada, and others, a number of courses detailing regulations in global areas were created. Additionally, the curriculum has been expanded to include courses such as emerging product categories (to cover up and coming regulations), generic medications, quality management systems (QSRs), and supplier-risk management.
Our curriculum is intensely practical, with six courses on regulatory documentation processes and a capstone practicum course. It is also current; covering such topics as post-market surveillance, pharmacovigilance, and managing international clinical trials. There are three areas of program distinction for NU’s regulatory affairs curriculum. Among the handful of graduate programs in the United States offering a Master’s degree, most offer three or four courses on medical devices: NU offers fourteen. Most of the competing programs will offer two or three courses on international topics; NU offers thirteen.
Most instruction in regulatory affairs, whether delivered by a private commercial entity or university, focuses on regulatory compliance. In contrast, NU’s program in regulatory affairs emphasizes the belief that decisions involving which products to develop and how to develop them are both strategic and regulatory in nature. Regulatory considerations can inform a company’s plan to create a sustainable competitive advantage. As such, our curriculum and instruction provide regulatory professionals with the language and understanding needed to effectively interact with a company’s strategic planners. Courses in this area include: biomedical intellectual property management; strategic planning and project management for regulatory affairs professionals; advertising and marketing biomedical products; regulatory considerations for start-ups; and, product development from concept development to market success.
NU’s regulatory affairs courses are offered both on campus and online. Students can complete their degree entirely online, as each of the programs forty-three courses are offered at least twice a year online. All of the six required core courses are offered every term online. As a result, the program features students from across the United States and from thirty-four foreign countries.
NU is a global leader in online learning. With more than two decades of experience in delivering distance education, NU maintains the highest possible standard for online course development, course delivery, and faculty training. NEU is committed to the principle that online courses can and should meet the same standard of academic rigor as any face-to-face class. Our online courses are asynchronous, meaning that no single student needs to online at one particular moment. Instead, our learning platform allows students to participate any time of the day, with the requirement that they be logged-on for a 60-90 minute period per day.
NU believes that graduate training in regulatory affairs is ideally suited for online learning. Our online courses are highly interactive, allowing students to interact with the faculty and their fellow students on a daily basis. To learn more about the Seattle Campus Master of Science Regulatory Affairs, please contact Gina Takasugi at email@example.com.