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.


Meet Our
2024 Graduates!

News and Highlights

from our Regulatory Science Community

Dissertation Insight! Global Pharmacopeial Harmony: Simplifying Medicine Standards 
This Dissertation Insight highlights Catherine M. Sheehan, DRSc, and her research on the challenges of achieving harmonized pharmacopeial standards across regions.
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OpenRegSource: Regulatory Resources to Advance Your Research
Academic researchers are challenged with navigating through regulatory hurdles, which often requires a great deal of time to search for information. In an effort to provide a solution, OpenRegSource was developed by SC CTSI’s Regulatory Knowledge and Support Core in collaboration with USC Mann’s D.K. Kim International Center for Regulatory Science and the Department of Regulatory and Quality Sciences. OpenRegSource provides a free, easily accessible, self-help tool to obtain basic regulatory information prior to seeking professional and/or paid consultation.
Access OpenRegSource
Dissertation Insight: Shaping a Safer Tomorrow: Decoding Drug Compounding
In this Dissertation Insight, we highlight the research of Victor Gangi, DRSc, whose work explores current thinking and approaches to drug compounding.
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New Clinical Trial Quality Training Module Now Available
New Clinical Trial Quality Training Module Now Available The third and final installment of the Clinical Trial Quality Training Series is now available, focusing on Site Preparedness for FDA Inspection. Find out more about this open-access self-study educational resource and enroll for free.
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News from Research: Spring 2024 Poster Acceptances
Faculty, staff, and student-researchers in the Department of Regulatory and Quality Sciences uncover new knowledge around pharmacologic, medical, and regulatory-related topics through research. This winter, one staff member and eight regulatory science student researchers working with a faculty mentor were accepted to present at the American Pharmacist Association (APhA) and Association for Clinical and Translational Science (ACTS) conferences happening this spring.
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Fostering Innovation Through Research: USC Provost’s Spring 2024 RegSci Fellowship Awardees
Fostering Innovation Through Research: USC Provost’s Spring 2024 RegSci Fellowship AwardeesFour regulatory science student researchers were awarded the USC Provost’s Undergraduate Research Fellowship this spring. Congratulations to these student researchers!
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Dissertation Insight! Precision in Safety: Innovating Against Regulatory Shifts in Medical Devices
In this Dissertation Insight, we highlight the research of Michael Yartzoff, DRSc ’22, MS, MBA, whose work explores current practices in the biocompatibility assessment of medical devices.
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Programs

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 Headshot

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 Headshot

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 Headshot

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

Terry David Church, DRSc, MA, MS

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

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.