Advancing the Profession
One of the first programs in this dynamic arena, the Department of Regulatory and Quality Sciences remains a global leader in producing professionals with the knowledge and skills to manage regulated biomedical products worldwide. This rapidly growing and increasingly global field encompasses every aspect of pharmaceutical and medical device development, quality assurance and clinical trials oversight—helping shepherd life-improving and often lifesaving advances to the marketplace.
Make Informed Decisions: Key Statistical Principles to Clinical trial DesignHow do investigators and sponsors make informed decisions about the clinical trials they are designing and executing? How do I make it both equitable and heterogeneous as well as statistically valid? Come to this one-day symposium on Friday, February 4, 2022 to hear from experts in their fields and have these and other questions answered.
Neal E. Storm, DRSc et al publish on using real-world evidence to support product registration in ChinaA publication by doctoral graduate Neal Storm and colleagues describes how real-world data can be used instead of clinical bridging studies for registration in China.
Drs. Loeb and Richmond publish “Turning Neural Prosthetics Into Viable Products”Dr. Gerald Loeb and Dr. Frances Richmond collaborated on an article for Frontiers in Robotics and AI titled “Turning Neural Prosthetics Into Viable Products.”
Dr. Frances Richmond moderates international panel on medical device regulation Frances Richmond, Director of the USC-APEC Center for Training Excellence, was a member of the program committee and a moderator of panel discussions for the 2021 AHC-SCH Medical Device Forum, held virtually Oct. 14 and 21, as part of joint activities with the Soonchunhyang University (SCH) APEC Center of Training Excellence, and the APEC Harmonization Center, in Korea. This program allowed several USC graduate students in regulatory science to attend and learn about global regulatory management of digital technologies and in vitro diagnostic devices during the current pandemic and in the future.
Center for Regulatory Science
Aligning Regulatory Standards for Global Impact
What is Regulatory Science?
Resources to learn all about our field
“Options in regulatory affairs – specialties and skill sets” by RegSci faculty member
DIA – Drug Information Association
RAPS – Regulatory Affairs Professional Society
FDA – U.S. Food and Drug Administration
OCRA – Orange County Regulatory Affairs
ASQ – American Socity for Quality
FDLI – Food and Drug Law Institute
Institute of Food Technologists
FDA article “Why You Should Care About Regulatory Science.”
The Latest from the Department of Regulatory and Quality Sciences
Mirroring the working environment of the industry, our programs emphasize collaborative problem-solving, communication, teamwork, cross-functional fluency and other soft skills essential for success in all aspects of regulatory and quality sciences—from shaping individual company strategies to ushering in systemic change to advance the entire profession. We also focus on regional and cultural sensitivities, comparative regulations and other knowledge critical for the rapid globalization of regulatory science.
There is a growing need for talent with skillsets that combine scientific foundation, business understanding and regulatory knowledge. A graduate degree in regulatory science can prepare students for a career in this industry that is both exciting and rewarding.
Eunjoo Pacifici, PharmD, PhD
Highlights / Benefits
Flexible and Individualized
In keeping with the versatility of regulatory and quality sciences as a career path, our programs emphasize flexibility and customization. They are tailored to accommodate busy professionals and designed to meet your current needs and long-term goals. You set your own pace, taking the number of classes you prefer, when and where you need them—on weekends and evenings, online, in the classroom or in a blended format. Class sizes are kept intentionally small to foster networking and group interactions. Individual classes can also be taken without enrolling in a graduate program. If you later choose to apply and are accepted, the coursework you have completed prior to admission will count toward your graduate certificate or master’s degree. And as you continue to progress in your career, you can come back and earn your doctorate. We focus on the whole person, individualizing your experience in the program and helping you forge a career path that’s suited to you alone. You’ll have the chance to take advantage of unique training opportunities through industry, government and other internships.
Meet the Faculty
Frances J. Richmond, PhD
Nancy Pire-Smerkanich, DRSc, MS
Eunjoo Pacifici, PharmD, PhD
C. Benson Kuo, PhD
Terry David Church, DRSc, MA, MS
Susan Bain, DRSc
Opening Doors of Opportunity
Browse our department viewbook to learn more about our pioneering and comprehensive curriculum, the USC Department of Regulatory and Quality Sciences at the USC School of Pharmacy is internationally renowned for preparing new leaders in this dynamic industry.