Written By: James Polli, PhD, the Shangraw/Noxell Endowed Chair in Industrial Pharmacy and Pharmaceutics
To help address the national need for scientists trained in the field of regulatory science, the School of Pharmacy launched the MS in Regulatory Science program at the School of Pharmacy in 2013. A part-time, online program, the MS in Regulatory Science is designed to provide working professionals with the knowledge and skills necessary to contribute to drug and biologics regulation and pharmaceutical product lifestyles. By January 2014, the program had enrolled its first students. Now, two years later, it was an honor to watch those students receive their hoods during the program’s inaugural convocation ceremony held at the School on May 19.
Celebrating Our Graduates’ Success
Even though the MS in Regulatory Science program is offered exclusively online, more than 50 graduates who completed the program in both Fall 2015 and Spring 2016 traveled to Baltimore from various countries around the world with their families to attend the ceremony. It was wonderful for our graduates to have an opportunity to meet each other in-person, as most students primarily communicate with each other via the phone and Internet when completing coursework.
The keynote address was delivered by Carol D. Linden, PhD, the director of the Office of Regulatory Science and Innovation in the Food and Drug Administration’s (FDA) Office of the Commissioner. She noted that the day represented “not only a milestone in your [graduates] lives, but also a milestone in the life of the [MS in Regulatory Science] program,” while also speaking about the numerous opportunities that exist to better integrate science into drug, biologics, and device development.
In addition, since its inception, the program has benefitted from numerous guest lecturers who work in industry and at regulatory agencies. Two of those lecturers – Tom Edkins, PhD, principal at Edkins Pharma Services, LLC, and Barbara Davit, PhD, clinical monitor at Merck – attended the ceremony to watch as the students that they taught received their hoods, confident that they now possessed the knowledge and skills necessary to contribute to drug and biologics development and assessment. It was great to see them in the audience, as their presence truly underscored the commitment that our faculty and lecturers have to the success of the students in our program.
Going Above and Beyond for Their Education
Aziza Ahmed, MSc, associate director of regulatory affairs for emerging Asia and Korea at Baxter Healthcare, traveled nearly 10,000 miles from Singapore to receive her hood and deliver remarks on behalf of the Class of 2015. She spoke about the challenges that the coursework often presented to her and her group members, but emphasized how the rigor of the program made for a great learning experience. “I know that the lessons that we learned over these past few years will serve us well as we continue to advance our careers in the ever-expanding field of regulatory science,” she said.
Darrell Orr, MSc, associate director for clinical quality and compliance at Janssen Pharmaceuticals, was also present to receive his hood and deliver remarks on behalf of the Class of 2016. “Before I enrolled in the program, I thought that I had received all of the necessary training to advance my career. However, the additional knowledge and skills that I have obtained from the MS in Regulatory Science program at the School of Pharmacy have elevated my knowledge base to a much higher level,” he added.
Two additional graduates were also recognized during the ceremony with awards for outstanding performance in regulatory science: Carolyn Volpe, MSC, an officer in the Public Health Service and consumer safety officer in the FDA’s Office of Unapproved Drugs and Labeling Compliance, and AnnMarie Kerns, MSc, director of regulatory compliance for the University of Maryland School of Medicine’s Maryland Psychiatric Research Center.
Looking to the Future
The events of the day were filled with excitement not only for the graduates, but also for the faculty and staff of the MS in Regulatory Science program who have dedicated their time and effort to ensuring that students had all of the tools and resources needed to make it to this special day. We look forward to hearing about all of the great accomplishments that our graduates are sure to achieve as they continue to advance in their careers.