Degree Programs at USC Regulatory Science

MASTER’S PROGR AMS

MASTER YOUR CAREER Our master’s programs are uniquely designed to meet the growing need for highly trained professionals in this stimulating and diverse field. Courses are offered on weekends to accommodate busy professionals, while our distancelearning option allows you to participate online from anywhere in the U.S. With our on-campus, online programs or a blended approach, you set your own pace, taking as many courses as you want each semester. To see if our program is right for your needs, you can also try a course or two without formally applying.

WE OFFER FOUR MASTER OF SCIENCE (MS) DEGREES:

MS in Regulatory Science, an intensive, interdisciplinary program that covers the latest trends in domestic and global regulation, as well as quality practices in the biotechnology, pharmaceutical and medical device industries. Real-world projects and case studies provide a firm foundational knowledge in regulatory, quality and clinical sciences. You will also gain an understanding about the many complexities of blending engineering, pharmaceutical and regulatory sciences on a global scale.

MS in Management of Drug Development hones skills for careers in translational research, with particular emphasis on shepherding the transition between earlystage preclinical drug discovery and clinical drug development. The program

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The USC regulatory science program lets me see everything from the big picture to the micro details of the field.

Faculty here have practical experience so, when they illustrate a regulation, they use real-world examples from their own careers. Students also benefit from the interdisciplinary backgrounds of fellow students as we work on projects together.

PENG-SHENG C. MS in Medical Product Quality

enables you to design, critically evaluate and optimize broad drug development strategies from the earliest stages of discovery to their application in patents, ultimately leading to commercialization.

MS in Medical Product Quality instills you with the practical knowledge to ensure safety and effectiveness while detailing the principles that guide current and future regulations. Courses cover regulatory issues related to the quality of drugs, biologics and medical devices in the U.S. and internationally.

You will leave the program prepared to meet the needs of employers and the public in this ever-expanding field.

MS in Regulatory Management prepares postdoctoral scientists and clinicians to evaluate research studies and strategically plan product development and commercialization. Our interdisciplinary curriculum provides advanced training in several regulatory subsectors related to pharmaceuticals, medical device and clinical research, as well as a grounding in business and management practices. The program also fosters teambuilding and human resource development skills critical to your success in the field.

TIMELINE:

On average, most students complete their degrees in two years or less, but if you take only one course per semester, you may need three years to finish the program.

DOCTOR AL PROGR AM

UNPARALLELED PREPARATION The first of its kind in the world, our professional doctorate in regulatory science (DRSc) cultivates research, leadership and inquiry skills in advanced students who want to operate at the pinnacle of the field globally. Through the program, you will gain particular expertise in strategic management, policy development, research assessment and preparation to work in senior positions in the public sector, academia and life sciences industry.

Instead of a traditional doctor of philosophy degree, our DRSc gives graduates the potential and background for careers in government and industry settings as well as the more traditional PhD trajectory of scholarly and academic roles. Most candidates have between 10 and 15 years of experience in the regulated product industry with several years of experience managing or directing regulatory or quality departments.

During the program, you will take interdependent courses that extend from a strong core of basic regulatory science coursework to focus on three main areas: global product strategy, product lifecycle strategy, and project and human resources management.

All students in the program are required to visit regulatory agencies in Europe and Asia, as well as North America.

You also will be mentored by two identified advisors — one from our full-time faculty and the other an industry or government leader serving as an adjunct professor in the program — as well as receive informal support and guidance by other experts throughout the program.

TIMELINE:

On average, coursework can be completed in four to five years, with the final year devoted to research and writing your dissertation.

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The doctoral program takes you to the top tier of global regulatory expertise, and equips you with … insight that is invaluable to your ability to navigate the global regulatory environment. As a doctoral candidate, you have the opportunity to work face-to-face with the highest level of health-authority representatives in a setting that is just not [otherwise] available to regulatory professionals in industry today.”

MARTIN S. MBA 1991, USC MS Regulatory Science 2008, USC DRSc 2011 Vice President, Head of Rare Blood Disorder, Global Regulatory Affairs Sanofi Genzyme

CERTIFICATE PROGR AMS

CERTIFIED SUCCESS Our accredited graduate certificates develop specialists for high-demand areas within the broader field of regulatory and quality science. Programs are structured so working professionals can take one or two courses per term during weekends or online. Each certificate can stand alone or you have the option to build upon your coursework and apply it later toward a master’s degree or our doctoral program.

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I work as a postdoctoral fellow at the USC Broad Center for Regenerative Medicine and Stem Cell Research. The regulatory science program’s classes show how our basic research goes from the bench to the clinic to the patient. There are a lot of jobs for someone who can bridge the gaps between basic research, clinical research and the regulatory aspects of any kind of product development.”

RAJIV T. Graduate Certificate in Clinical Research Design and Management

The Graduate Certificate in Medical Product Quality is designed for students with backgrounds in biological, pharmaceutical and biomedical sciences or biomedical engineering who seek to expand their expertise in this thriving sector.

The Graduate Certificate in Clinical Research Design and Management provides an ideal training platform for those interested in research at a clinical site or in a medical products company.

The Graduate Certificate in Food Safety helps meet the growing need for regulatory and safety experts in the food and supplement industries.

The Graduate Certificate in Patient and Product Safety prepares risk managers and pharmacovigilance experts for careers safeguarding against healthcare product problems.

The Graduate Certificate in Preclinical Drug Development provides advanced training for individuals interested in preclinical aspects of translational medicine and associated research.

The Graduate Certificate in Regulatory and Clinical Affairs acquaints individuals with the world of medical product regulation and prepares them for roles in the regulatory and quality aspects of medical product development.

TIMELINE:

Our 12-unit certificates are typically completed in two to four semesters.