USC
University of Southern California
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Certificate Programs

Regulatory Science Program
USC School of Pharmacy
1540 Alcazar St., CHP G32
Los Angeles, CA 90089
(323) 442-3102
Email: regsci@usc.edu
regulatory.usc.edu

Certificate in Clinical Research Design and Management

The graduate certificate in clinical research design and management is designed to strengthen the statistical, research and project management skills of clinical researchers and their associated clinical team members. Students must complete at least 12 units of course work including at least two courses in clinical design and trial management, one course in ethics and one course in a specialized aspect of design, management or statistics, subject to the approval of the program director. The program will include course work delivered in nontraditional formats such as intensive weekend sessions and will use distance learning tools, Web-cast lectures and study materials. Courses can be taken on site, by distance or as a blended combination. Students should confirm their specific course work plan in consultation with the graduate advisors before beginning the program. Students who have bachelor's degrees from accredited colleges or universities must submit an application for graduate study through the regulatory science program of the School of Pharmacy. GRE scores are not required for admission to the certificate program. Students are expected to enroll each semester until the program is completed.

Requirements Units
Introduction to Clinical Trials
MPTX 517 Structure and Management of Clinical Trials 4

Clinical Design/Statistics (choose one)
PM 510L Principles of Biostatistics4
MPTX 522 Introduction to Clinical Trial Design and Statistics 3

Biomedical Ethics
MPTX 602 Science, Research and Ethics 2

Additional options in specialized aspect of design or management (choose one):
MPTX 511 Introduction to Medical Product Regulation 3
MPTX 520 Risk Management for Health Care Products 3
PM 510LPrinciples of Biostatistics4
PM 511a Data Analysis 4
PM 512 Principles of Epidemiology 4
PM 523Design of Clinical Studies3
RSCI 527 Medical Product Safety 3
RSCI 528 Safety in the Health Care Environment3

Certificate in Food Safety

The graduate certificate in food safety is a 12-unit program of course work designed to strengthen the knowledge base and functional "toolkit" of individuals who deal with the production and management of food in industry and government. Students are required to take an entry level course that focuses on regulatory requirements for foods and dietary supplements and two additional courses that focus on food science and food/drug toxicology respectively. Final course work will be selected from a small grouping of electives that deal with quality systems or risk management. The program will include course work delivered in nontraditional formats, such as intensive weekend sessions, and will use distance learning tools, Web-cast lectures and study materials. Courses can be taken on site, by distance or as a blended combination. Students should confirm their specific course work plan in consultation with the graduate advisors before beginning the program. Students who have bachelor's degrees from accredited colleges or universities must submit an application for graduate study through the regulatory science program of the School of Pharmacy. GRE scores are not required for admission to the certificate program. Students are expected to enroll each semester until the program is completed.
REquirements Units
MPTX 514 Regulation of Food and Dietary Supplements 3
MPTX 524 Introduction to Food Science and Technology 3
RSCI 525 Introduction to Drug and Food Toxicology 3

Quality/Risk Management Option:
MPTX 515 Quality Systems and Standards 3
MPTX 526 Chemistry Manufacturing and Controls 3
RSCI 520Introduction to Risk Management for Health Care Products2
RSCI 529 Application of Risk Management Tools and Techniques 2

Certificate in Patient and Product Safety

The graduate certificate in patient and product safety is a 12-unit program that educates students in the emerging field of safety and risk management in the health care environment. It is designed to produce graduates who have a particular expertise in the evaluation and mitigation of medical errors and health-care product problems. Course work is typically delivered in nontraditional formats such as intensive weekend sessions and will use distance learning tools, Web-cast lectures and study materials. Courses can be taken on site, by distance or as a blended combination. Students should confirm their specific course work plan in consultation with the graduate advisors before beginning the program. Students who have bachelor's degrees from accredited colleges or universities must submit an application for graduate study through the regulatory science program of the School of Pharmacy. GRE scores are not required for admission to the certificate program. Students are expected to enroll each semester until the program is completed.

Students must complete 12 units of specified course work, that normally will include an introductory course in the basic principles of risk management, a second course in the use of risk management tools, and two additional courses in patient and product safety respectively as listed below. In addition, a course in medical ethics is recommended. Most students will take the courses that are listed in the sample student program below, but if students have already strong previous experience in risk management or safety, other statistical or quality courses taught in graduate programs at USC may be substituted with the permission of the program director. The certificate can be completed on a part-time basis but must be finished within five years.

Requirements Units
MPTX 602 Science, Research and Ethics2
RSCI 520 Introduction to Risk Management for Health Care Products 2
RSCI 527Medical Product Safety 3
RSCI 528 Safety in the Health Care Environment 3
RSCI 529Application of Risk Management Tools and Techniques 2

Certificate in Preclinical Drug Development

The graduate certificate in preclinical drug development provides advanced foundational training in preclinical aspects of drug development, translational research and regulatory control. Students must complete at least 12 units of course work including at least three courses in preclinical design and development (typically, RSCI 530 Translational Medicine: An Overview; RSCI 531 Drug Discovery; RSCI 532 Early Stage Drug Development) and one course in a related aspect of research design, regulation or ethics, subject to the approval of the program director. The program will include course work delivered in nontraditional formats such as intensive weekend sessions and will use distance capabilities, Web-cast lectures and study materials. Courses can be taken on site, by distance or as a blended combination. Students should confirm their specific course work plan in consultation with graduate advisors before beginning the program. Students who have baccalaureate degrees from accredited colleges or universities must submit an application for graduate study through the regulatory science program of the School of Pharmacy. GRE scores are not required for admission to the certificate program. Students are expected to enroll each semester until the program is completed.