Catalogue 2012/13

Certificate Programs

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, Webcast 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 advisers 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.

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, Webcast 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 advisers 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.

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, Webcast 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 advisers 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.

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, Webcast 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 advisers 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.

Certificate in Regulatory and Clinical Affairs

The graduate certificate in regulatory and clinical affairs is designed to provide specialized education for individuals interested in developing a systematic understanding of the U.S. regulatory system for medical products. Students must complete at least 12 units of course work including an introductory course in regulatory affairs:

Other courses may be substituted with 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 to capture and Webcast 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 advisers before beginning the program. Students who have a baccalaureate degree from an accredited college or university must submit an application for graduate study through the regulatory science program of the School of Pharmacy. This program is particularly directed at Ph.D. students who wish to take the certificate during their USC studies. GRE scores are not required for admission to the certificate program. Students are expected to enroll each semester until the program is completed.

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