Department of Regulatory and Quality Sciences

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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.

News and Highlights

from our Regulatory Science Community

Medical Product Liability Litigation Day
Join the Department of Regulatory and Quality Sciences four seasoned trial lawyers from globally recognized law firm, King & Spalding, as we bring medical product liability litigation to life! Open to faculty/staff, alumni, and students.

When: Saturday, December 2, 9:30am-4:00pm Pacific
Where: In-person at USC Health Sciences Campus (Remote option available)
*Lunch and refreshments will be provided to on-site attendees*
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USC Hosting APEC Economies at Health Sciences Campus
The USC-Asia Pacific Economic Cooperation (APEC) Center of Excellence is pleased to host a program entitled “Harmonizing Medical Device Regulation” on October 12-13, 2023 at the USC Health Sciences Campus. This meeting brings together regulators from over 10 countries from APEC economies across the globe to train them in medical device regulations.
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D.K. Kim Center: Strengthening Regulatory Systems Across the Globe
Dr. Larry Liberti, Director of the DK Kim International Center for Regulatory Science was featured in two webinars for the South African Health Products Regulatory Authority, coordinated by The Boston Consulting Group. In July 2023, Dr. Liberti presented “Regulatory Reliance: Best Practices and Benefits and “Reliance-based Regulatory Decisions” to the agency. Academic outreach informed by novel research and data is at the core of the DK Kim Center’s regulatory system-strengthening initiatives.
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Faculty Awarded 2023-2024 Undergraduate Research Associates Program (URAP) Funds
Three faculty in regulatory and quality sciences received URAP awards as lead investigators to engage undergraduate students to research topics in the regulatory science and translational research disciplines.
Boosting AAPI Diversity in Clinical Trials
Eunjoo Pacifici, PharmD, PhD, Chair and Associate Professor of Regulatory and Quality Sciences, was featured in an article for Asian American and Pacific Islanders (AAPI) month about the importance of boosting diversity in clinical trials.
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Roger Clemens Publishes on Nutrition, Food Science and Toxicology
USC School of Pharmacy, Department of Regulatory and Quality Sciences adjunct professor, Roger Clemens, DrPH, has added five more publications to his running list of more than 80 manuscripts on nutrition, food science, and toxicology.
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ICRS-CTIP Collaborative Publishes a Novel MedTech Startup Maturity Index (SMI)
A true embodiment of collaboration by Doctor of Science in Regulatory Science candidates, “A Novel Maturity Index for Assessing Medical Device Startups" has been accepted for publication in the Journal for Clinical Translational Sciences. The authors developed a novel MedTech Startup Maturity Index (SMI) as an assessment and educational tool for startup medical device companies, pediatric medical device accelerators, and MedTech investors.
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DK Kim International
Center for Regulatory Science

Aligning Regulatory Standards for Global Impact

Industry Relevant​

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.

eunjoo testimonial headshot
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​

Chair, Department of Regulatory and Quality Sciences

Highlights / Benefits

Meet the Faculty

Frances J. Richmond, PhD

Frances J. Richmond, PhD

An expert in implantable medical devices, clinical trial regulatory issues, and regulation of pharmaceuticals and medical device products.
Nancy Pire-Smerkanich, DRSc, MS

Nancy Pire-Smerkanich, DRSc, MS

Professional who brings 30 years of industry experience in drug development to academia
Eunjoo Pacifici, PharmD, PhD

Eunjoo Pacifici, PharmD, PhD

Eunjoo Pacifici is an expert in drug regulations, the global pharmaceutical market, and international medical product regulations.
C. Benson Kuo, PhD

C. Benson Kuo, PhD

C. Benson Kuo's research focuses on regulatory issues for innovative medical products and product safety in Asia.

Terry David Church, DRSc, MA, MS

Expert in biorepository regulation and ethics, and drug addiction and regulation of controlled substances
Susan Bain, DRSc

Susan Bain, DRSc

Accomplished quality and regulatory professional with experience in the medical device and pharmaceutical industries

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 USC Mann is internationally renowned for preparing new leaders in this dynamic industry.