Articles, White Papers & Dissertations

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About Regulatory Science at USC:

“Quality Counts in New Master’s Degree at School of Pharmacy”
“Director of Regulatory Science program receives Award for Excellence”
“Regulatory Science Students Visit Bay Area Manufacturers”
“USC Pharmacy Program Targets Drug Development”


About Careers in Regulatory Science:

“Options in regulatory affairs – specialties and skill sets” by RegSci faculty member
Nancy Pire-Smerkanich
“Regulatory Science:  Researchers in the Pipeline” – Nature
“All in the Details:  Careers in Regulatory Science” – Science
“5 High-paying Science Jobs and How to Get Them” – Money
“Perspectives on an alternative career path in regulatory science”
“Medical Device Skill Training for Entry-Level Workers: Help Is On The Way”
“FDA: Why You Should Care About Regulatory Science”

More Career Info:

What You Need to Know Before Taking a Biotech Startup Job


Published in Food, Medicine, & Health by RegSci faculty member Dr. Roger Clemens:
Could EFSA’s Warning About 3-MCPD in Edible Oils Affect the U.S. Food Industry?
“Comfort and Mood Foods”
“Doubts About Vitamin B Fortification”
“Nutrigenomics: From Nutrition to Genes”


White papers, articles, & publications

Postmarket Surveillance in a Digital Health Solution World, by Darin Oppenheimer DRSc (’17), Guo, Hale, Cusatis, Ramachandran, & Visc0
Medical Device and Risk Management, by Darin Oppenheimer DRSc (’17) and Suraj Ramachandran (RAPS, 14 February 2018)
Connected Device System Validation & Quality – Best Practices; by Carolyn Wright, USC Reg Sci DRSc student (JVT Journal, August 2017)
Organizational Culture and Memory in Managing Risk in the Medical Device Industry; by Darin Oppenheimer, DRSc & Suraj Ramachandran (Regulatory Affairs Professional Society, August 2017)
Standard Comparison: Assessing risk management processes for regulated health industries; by Carolyn Wright, USC RegSci DRSc student (Quality Progress, June 2017)
What’s Behind Medtech’s Recall Epidemic? Part 3: Production Controls; Joshua R. Dix, Suraj Ramachandran, and Darin S. Oppenheimer (July 2016)
What’s Behind Medtech’s Recall Epidemic? Part 2: Software Controls. Joshua R. Dix, Suraj Ramachandran, and Darin S. Oppenheimer (July 2016)
What’s Behind Medtech’s Recall Epidemic? Part 1: Device Design. Joshua R. Dix, Suraj Ramachandran, and Darin S. Oppenheimer (June 2016)
Role of Purinergic P2X4 Receptors in Regulating Striatal Dopamine Homeostasis and Dependent Behaviors. Journal of Neurochemistry; Khoja S, Shah V, Garcia D, Asatryan L, Jakowec MW, Davies DL. Accepted for publication; in press.
Navigating the Paradigm Shift in Biomedical Research and Development: Orphan Drug Regulation and Product Development Strategy; Eunjoo Pacifici, PharmD, PhD
A Pilot Study of the Safety and Initial Efficacy of Ivermectin for the Treatment of Alcohol Use Disorder; Daryl Davies, Ph.D. et all (April 2016)
Utilizing an Orally Dissolving Strip for Pharmacological and Toxicological Studies: A Simple and Humane Alternative to Oral Gavage for Animals; Daryl Davies, Ph.D. et all (March 2016)
ICH Revisions for Benefit-risk Assessment by Nancy Smerkanich, DRSc (January 2016)
3rd Annual Proceedings of the BMES ERC/IBT Summer Research Programs (Summer 2015)
Incentivizing Quality in the Manufacture of Pharmaceuticals: Industry Views on Quality Metrics and Ratings; Cesar Medina, DRSc and Frances Richmond, PhD (May 2015).
Cultivating Talent for Korea’s Biopharmaceutical Industry; Eunjoo Pacifici, PharmD, PhD:
English     –Korean
Options in Regulatory Affairs- Specialties and Skill Sets; Nancy Pire-Smerkanich and David Locke (March 2015)
Escalation of Oncologic Services at the End of Life Among Patients with Gynecologic Cancer at an Urban Public Hospital; Terry Church, et al (February 2015).

White papers archive


Doctoral dissertations

Our students are leaders in their respective industries as well as in their academic contributions to the field of regulatory science.