Inspired to Compete by the Wide-Open Field of Regulatory Affairs

Regulatory Affairs Student Participates in Research Expo “RISE:2013”

JoAn Blake at RISE:2013, photo by Brooks Canaday.

JoAn Blake, a student in the Master of Science in Regulatory Affairs for Drugs, Biologics and Medical Devices program recently participated in RISE:2013 and presented her research on why all companies in the biotech field need to establish sound Quality Management Systems (QMS).

RISE, which is Northeastern University’s inno­va­tion, schol­ar­ship, and research expo, was held on March 22, 2013 on Northeastern’s campus in Boston. The annual event, spon­sored by the University’s Center for Research Inno­va­tion and the Office of the Provost, high­lights research across many dis­ci­plines and show­cases the breadth and depth of inno­v­a­tive thinking at Northeastern.  Awards were given for Outstanding Student Research in eight categories. Awards came along with grants to students to further their research or endeavor.

Blake, a Compliance Specialist at Cytonome, a biotech company in Boston, presented her abstract which focused on the need for companies to establish a QMS to ensure control and reproducibility during the development of a new product, in response to increasingly stringent regulatory standards. As Blake describes it, QMS is designed to ensure that the right controls are established so that the right things happen at the right time, resulting in a consistently high quality final product.

“Attitudes are contagious and if we continue to think of engineering, science, innovation and regulatory affairs as separate components then we will continue to have things like the meningitis outbreak continue to happen,” explained Blake, about her integrated approach to quality management.

Blake, who started in the Master’s in Regulatory Affairs program in fall 2012 at The College of Professional Studies (CPS), is planning on graduating at the end of this year.

“This program is ideal for people like me,” said Blake, who holds a full-time job at Cytonome, is pursuing her master’s degree part-time, and also has three children, two of them twins. “CPS provides a framework for students with an active lifestyle like mine – with the availability and flexibility of blended classes.”

“My career goals seem to be morphing constantly,” she said. “As I go through this program I realize that this industry is an open frontier and the ’sky is the limit,’ said Blake, who originally had plans to be a regulatory affairs professional working in a biotech or pharmaceutical company.

Next year, she hopes that more students from CPS participate in RISE:2014 given she found that “the other Colleges showed up in full force.”

“The College and the Regulatory Affairs program both have critical information that needs to be presented,” she commented.

Northeastern University’s College of Professional Studies (CPS) is committed to providing career-focused educational programs that are designed to accommodate the complex lives of motivated learners. Offered in a variety of innovative formats, CPS courses are taught by accomplished scholars and practitioners who have real-world experience. The result is an educational experience founded on proven scholarship, strengthened with practical application, and sustained by academic excellence.

Founded in 1898, Northeastern is a comprehensive, global research university. The university offers more than 80 undergraduate majors and more than 165 graduate programs, ranging from professional master’s degrees to interdisciplinary PhD programs. Northeastern’s research enterprise is aligned with three national imperatives: health, security and sustainability. Northeastern students participate in co-op and other forms of experiential learning in 90 countries on all seven continents.