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Public Health |
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P H 666 - Health Promotion Program Planning and Assessment
Units: 3
Prerequisite(s): P H 661 .
Program planning and assessment, theories, systems and procedures relevant to health promotion and education.
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P H 667 - Prevention and Control of Chronic Diseases
Units: 3
Prerequisite(s): P H 601 and P H 602 .
Health promotion strategies for modification of individual behaviors and social practices to lower risk of chronic disease.
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P H 668 - Seminar in Health Promotion Research
Units: 3
Prerequisite(s): Graduate standing in public health.
Philosophical, ethical and methodological issues in current health promotion research and services.
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P H 672 - Public Health Program Evaluation
Units: 3
Prerequisite(s): Graduate standing. Recommended: P H 666 .
Activities, processes, and skills to include communicating results, contextual issues, design, methods, steps, and ensuring summative findings are used.
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P H 682 - Geographic Information Systems and Public Health Spatial Analysis
Units: 3
Two lectures and two hours of activity.
Prerequisite(s): P H 601 and P H 602 .
Theoretical concepts of geographic information systems (GIS) and applications of GIS in public health. ArcGIS 9 software to illustrate the capabilities and uses of GIS in both academic research and regulatory decision making.
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P H 696 - Contemporary Topics in Public Health
Units: 1-3
Intensive study in specific areas of public health and health services administration. May be repeated with new content.
Note: See Class Schedule for specific content. Credit for 596 and 696 applicable to a master’s degree with approval of the graduate adviser.
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P H 700 - Seminar in Public Health
Units: 1-3
Prerequisite(s): P H 601 , P H 602 , and P H 603 .
Investigation of current problems in one of the fields of public health. May be repeated with new content. Maximum Credits: nine units of Public Health 700 applicable to a master’s degree. These units may be in a single concentration area or any of the public health concentration areas.
Note: See Class Schedule for specific content.
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P H 700A - Seminar in Public Health: Epidemiology
Units: 1-3
Prerequisite(s): P H 601 , P H 602 , and P H 603 .
Investigation of current problems in one of the fields of public health. May be repeated with new content. Maximum Credits: nine units of P H 700 applicable to a master’s degree. These units may be in a single concentration area or any of the public health concentration areas.
Note: See Class Schedule for specific content.
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P H 700D - Seminar in Public Health: Environmental Health
Units: 1-3
Prerequisite(s): P H 601 , P H 602 , and P H 603 .
Investigation of current problems in one of the fields of public health. May be repeated with new content. Maximum Credits: nine units of P H 700 applicable to a master’s degree. These units may be in a single concentration area or any of the public health concentration areas.
Note: See Class Schedule for specific content.
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P H 700E - Seminar in Public Health: Health Management and Policy
Units: 1-3
Prerequisite(s): P H 601 , P H 602 , and P H 603 .
Investigation of current problems in one of the fields of public health. May be repeated with new content. Maximum Credits: nine units of P H 700 applicable to a master’s degree. These units may be in a single concentration area or any of the public health concentration areas.
Note: See Class Schedule for specific content.
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P H 700F - Seminar in Public Health: Health Promotion and Behavioral Science
Units: 1-3
Prerequisite(s): P H 601 , P H 602 , and P H 603 .
Investigation of current problems in one of the fields of public health. May be repeated with new content. Maximum Credits: nine units of P H 700 applicable to a master’s degree. These units may be in a single concentration area or any of the public health concentration areas.
Note: See Class Schedule for specific content.
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P H 700G - Seminar in Public Health: Preventive Medicine
Units: 1-3
Prerequisite(s): P H 601 , P H 602 , and P H 603 .
Investigation of current problems in one of the fields of public health. May be repeated with new content. Maximum Credits: nine units of P H 700 applicable to a master’s degree. These units may be in a single concentration area or any of the public health concentration areas.
Note: See Class Schedule for specific content.
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P H 720A - Capstone I
Units: 3
Prerequisite(s): P H 601 , P H 623 , P H 627 .
Develop hypotheses and research questions, use publicly accessible dataset, write epidemiologic report based on analysis. Institutional Review Board review process, literature review, table and figure creation, technical writing.
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P H 720B - Capstone II
Units: 3
Prerequisite(s): P H 720A .
Complete discussion, hypotheses, research questions, results, tables and figures for a final report. Create oral presentation to describe results.
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P H 724 - Advanced Methods in Epidemiology
Units: 3
Prerequisite(s): P H 601 , P H 623 , and P H 627 .
In-depth methodological issues in performance and interpretation of epidemiologic studies. Study design, cluster analysis, effect modification, accuracy and precision, adjustment of attributable risk, life tables, Kaplan-Meier, Cox proportional hazards modeling, and meta-analysis.
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P H 725 - Scientific Writing for Epidemiology
Units: 3
Grading Method: Cr/NC
Prerequisite(s): Completion of one year of master’s level coursework in epidemiology or biometry.
Prepares students to generate a feasible hypothesis, perform, organize and write a literature review, and summarize proposed methodology. Topics include research development and organization, finding data sources, principles of scientific writing and revising, plagiarism, and citation management.
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P H 726 - HIV/AIDS Epidemiology and Public Health
Units: 3
Prerequisite(s): P H 601 . Recommended: P H 621 .
State-of-the-art review of HIV and AIDS within a public health framework. Biology, transmission, host susceptibility, screening and surveillance, domestic and international epidemiology, study design, intervention, and options for prevention (including community- based trials).
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P H 728 - Applied Data Analysis
Units: 3
Prerequisite(s): P H 627 with a grade of B (3.0) or better.
Public health data and presentation of results. Linear regression, logistic regression for binary, missing data analysis, nominal and ordinal data, and survival analysis.
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P H 742A - Health Services Financial Management
Units: 3
Prerequisite(s): Graduate standing in public health.
Financial reporting statement including balance sheet and income statement. Financial management indicators including discounted cash flow analysis, long-term debt financing, equity valuation, risk and return, capital budgeting, financial forecasting, and short-term financing.
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P H 743 - Hospital and Ambulatory Systems Management
Units: 3
Prerequisite(s): P H 641 and P H 644A .
Organization and management of hospitals, integrated healthcare systems, medical group practices, and other ambulatory or outpatient facilities. Emphasis on service provision, programs, and plans. San Diego regional healthcare organizations highlighted.
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P H 747 - Quality Improvement and Program Evaluation
Units: 3
Prerequisite(s): P H 647 .
Health services quality measurement and improvement to include quality systems policy and management; outcomes and performance measurement; process quality improvement methods; program evaluation methods; development of evidenced-based practices and electronic medical records; and administrative databases.
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P H 748 - Health Services Competitive Strategy and Marketing
Units: 3
Prerequisite(s): P H 644B .
Ways in which healthcare organizations can gain and sustain competitive advantage. Both organization and service level competition and strategies/tactics examined.
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P H 750 - Advanced Field Practice
Units: 3-6
Grading Method: Cr/NC
Prerequisite(s): P H 650 .
Field instruction in public health setting. Application of public health principles and skills to public health problems. Maximum Credits: six units of Public Health 750 applicable to a master’s degree.
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P H 750A - Advanced Field Practice: Epidemiology
Units: 3-6
Grading Method: Cr/NC
Prerequisite(s): P H 650 .
Field instruction in public health setting. Application of public health principles and skills to public health problems. Maximum Credits: six units of P H 750 applicable to a master’s degree.
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P H 750D - Advanced Field Practice: Environmental Health
Units: 3-6
Grading Method: Cr/NC
Prerequisite(s): P H 650 .
Field instruction in public health setting. Application of public health principles and skills to public health problems. Maximum Credits: six units of P H 750 applicable to a master’s degree.
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P H 750E - Advanced Field Practice: Health Management and Policy
Units: 3-6
Grading Method: Cr/NC
Prerequisite(s): P H 650 .
Field instruction in public health setting. Application of public health principles and skills to public health problems. Maximum Credits: six units of P H 750 applicable to a master’s degree.
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P H 750F - Advanced Field Practice: Health Promotion and Behavioral Science
Units: 3-6
Grading Method: Cr/NC
Prerequisite(s): P H 650 .
Field instruction in public health setting. Application of public health principles and skills to public health problems. Maximum Credits: six units of P H 750 applicable to a master’s degree.
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P H 762 - Behavioral Medicine
Units: 3
Prerequisite(s): P H 661 and P H 662 .
Behavioral management approaches to health care problems. Diseases and conditions that arise from physical, psychological and environmental causes; behavioral interventions that attenuate disease process and improve compliance.
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P H 780 - Global Health I
Units: 3
Prerequisite(s): P H 601 and P H 602 .
Principles of global health. Challenges of urbanization and migration to include demography; main causes of morbidity and mortality, including infectious agents; reproductive health; cultural diversity; and global preparedness.
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P H 781 - Global Health II
Units: 3
Prerequisite(s): P H 780 .
Global health to include trends and impacts of chronic physical and mental disease; infectious diseases of global importance; nutritional status and disease patterns; resource constrained environments, and design of international health organizations and systems.
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P H 797 - Research
Units: 1-3
Grading Method: Cr/NC/RP
Prerequisite(s): Consent of instructor.
Research in one of the fields of public health. Maximum Credits: six units applicable to a master’s degree. Maximum combined credit six units of Public Health 797 and P H 798 applicable to a master’s degree.
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P H 798 - Special Study
Units: 1-6
Grading Method: Cr/NC/RP
Prerequisite(s): Consent of staff, to be arranged with the director and instructor.
Individual study. Maximum Credits: six units applicable to a master’s degree. Maximum combined credit six units of P H 797 and 798 applicable to a master’s degree.
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P H 799A - Thesis
Units: 3
Grading Method: Cr/NC/RP
Prerequisite(s): An officially appointed thesis committee and advancement to candidacy.
Preparation of a project or thesis for the master’s degree.
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P H 799B - Thesis Extension
Units: 0
Grading Method: Cr/NC
Prerequisite(s): Prior registration in Thesis 799A with an assigned grade symbol of RP.
Registration required in any semester or term following assignment of RP in Course 799A in which the student expects to use the facilities and resources of the university; also student must be registered in the course when the completed thesis is granted final approval.
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P H 799C - Comprehensive Examination Extension
Units: 0
Grading Method: Cr/NC
Prerequisite(s): Completion or concurrent enrollment in degree program courses.
Registration required of students whose only requirement is completion of the comprehensive examination for the master’s degree. Registration in 799C limited to two semesters.
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P H 800 - Seminar
Units: 1-9
Prerequisite(s): Admission to the doctoral program.
Investigation of a particular topic or issue, emphasis on empirical research; topic to be announced in the Class Schedule. Maximum Credits: nine units applicable to a doctoral degree.
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P H 820A - Modern Epidemiology Methods I
Units: 3
Prerequisite(s): P H 601 and P H 627 with a grade of A- (3.7) or better in each course.
Fundamentals of causal inference, quantitative measures of occurrence, association and effect, study design. Data analysis and interpretation, sources and mitigation of bias, review and critical appraisal of peer-reviewed literature.
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P H 820B - Modern Epidemiology Methods II
Units: 3
Prerequisite(s): P H 820A with a grade of B (3.0) or better.
Continuing examination of causal inference, quantitative measures of occurrence, association and effect, study design. Data analysis and interpretation, sources and mitigation of bias, review and critical appraisal of peer-reviewed literature.
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P H 823 - Case-Control Studies
Units: 3
Prerequisite(s): P H 601 , P H 623 , and P H 627 . Recommended: P H 724 .
Design, conduct, and analysis of case-control studies. Methodologic issues, control of biases and misclassification errors, proper use of interpretation of stratification and logistic regression in study of diseases of multifactorial etiology.
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P H 824 - Cohort Studies
Units: 3
Prerequisite(s): P H 601 , P H 623 , and P H 627 . Recommended: P H 724 .
Design, analysis, and application of cohort studies. Cohort study designs, importance of time-varying exposures and outcomes, external and internal validity, and in-depth treatment of approaches to analysis based on cohort sampling methods.
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P H 826 - Analysis of Case-Control Studies
Units: 3
Prerequisite(s): P H 623 and P H 627 .
Statistical methods and applications for analyzing case-control studies. Use of conditional and unconditional logistic regression and approaches for incorporating confounding and interaction in models. Computer applications included.
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P H 827 - Analysis of Cohort Studies
Units: 3
Prerequisite(s): P H 623 and P H 627 .
Statistical models for analyzing cohort studies including general regression methodology, generalized linear models, generalized estimating equations, random effects models and survival analysis. Emphasis on conceptual understanding of these models, implementation with statistical software, and interpretation.
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P H 850 - Global Health Practicum
Units: 3
Prerequisite(s): P H 781 , P H 800 , P H 880 .
An international research activity, program evaluation, participation in a multinational organization internship, or field work with government or non-governmental organizations. This practicum is required for completion of the Ph.D. in global health under supervision of program directors.
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P H 861 - Behavioral Measurement
Units: 3
Techniques for assessing behaviors related to health and health risks in key content areas. Multimodel assessment and validation procedures. Students will demonstrate ability to create new measures based on theory and reliability and validity of these measures, using multimodel assessment procedures.
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P H 862 - Advanced Theoretical Foundations of Health Behavior Research and Applications
Units: 3
Philosophy of science, role of theory development and design and conduct of research, with integration of behavioral and biological theories serving as foundation for behavioral science in public health.
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P H 863 - Advanced Communication Technology as Applied to Health Behavioral Interventions
Units: 3
Prerequisite(s): P H 663 , admission to the doctoral program, and consent of instructor.
Health communication theory and social marketing practice as applied to public health behavior change. Audience segmentation, formative research channel selection, and message development applied to chronic and infectious disease prevention.
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P H 864 - Advanced Research Methods
Units: 3
Prerequisite(s): Admission to the Joint Doctoral Program in public health with a concentration in health behavior.
Research process and study design to include conceptualizing research questions and hypotheses, observational study designs, quasi-experimental and experimental study designs, and introduction to qualitative research and mixed methods.
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P H 866 - Global Issues in Health Behavior Research and Application
Units: 3
Prerequisite(s): Admission to the doctoral program and consent of instructor.
Epidemics in infectious diseases, environmental degradation, population explosion, and other problems with behavioral links threaten the world’s population. Global issues such as the role of behavior in disease, bioterrorism, and war.
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P H 867 - Seminar: Grantwriting for Health Behavior Researchers
Units: 3
Prerequisite(s): Admission to Ph.D. in public health with a concentration in health behavior.
Skills needed to compete for health behavior research funding. Grant proposal writing, submission, review, and revision processes. Background information about grant review procedures and funding mechanisms, with emphasis on national institutes of health.
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P H 880 - Seminar: Program Planning and Evaluation in International Settings
Units: 3
Prerequisite(s): P H 780 .
Theory and skills to evaluate research and service programs in international settings to include methods in program planning and evaluation, distinctions between research and evaluation, special considerations in cross-cultural settings, and transadaptation of planning and evaluation materials.
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P H 897 - Doctoral Research
Units: 1-15
Grading Method: Cr/NC/RP
Prerequisite(s): Admission to the doctoral program.
Independent investigation in the general field of the dissertation.
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P H 898 - Doctoral Special Study
Units: 1-9
Grading Method: Cr/NC/RP
Prerequisite(s): Admission to the doctoral program.
Individual study in the field of specialization. Maximum Credits: nine units applicable to the doctoral degree.
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P H 899 - Doctoral Dissertation
Units: 1-15
Grading Method: Cr/NC/RP
Prerequisite(s): An officially constituted dissertation committee and advancement to candidacy.
Preparation of the dissertation for the doctoral degree. Enrollment is required during the term in which the dissertation is approved.
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Recreation and Tourism Management |
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RTM 101 - Recreation and Tourism Management
Units: 3
Role of recreation and tourism systems in contemporary society. History and philosophy, scope of services, facilities, programs, personnel, and evaluation.
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RTM 107 - Recreation Programming and Leadership
Units: 4
Three lectures and three hours of laboratory.
Theories, principles, and techniques of group leadership, group dynamics, communication, problem-solving, creativity, program planning, and publicity as they relate to selected recreation systems.
Note: Student ePortfolio is initiated.
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RTM 200 - Recreation, Travel, and Self-Awareness
Units: 3 GE
How recreation and travel are influenced by economic, environmental, political, and socio-cultural forces. Impacts of recreation and travel on well-being and self-awareness.
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RTM 284 - Supervised Field Work
Units: 3
Grading Method: Cr/NC
Prerequisite(s): Consent of instructor or department chair and 125 hours experience in recreation leadership.
Observation and participation in community recreation leadership. Practical experience in a variety of recreational settings. Eight hours per week at an agency.
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RTM 290 - Quantitative and Qualitative Literacy in Tourism
Units: 3
Prerequisite(s): RTM 101 or HTM 201 with a minimum grade of C (2.0).
Quantitative and qualitative methods in hospitality, recreation, and tourism fields. Gathering data from sources, summarizing data points, analyses, reporting findings/results, conclusions and recommendations.
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RTM 296 - Experimental Topics
Units: 1-4
Selected topics. May be repeated with new content.
Note: See Class Schedule for specific content. Limit of nine units of any combination of 296, 496, 596 courses applicable to a bachelor’s degree.
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RTM 304 - Leisure and Tourism
Units: 3 GE
Study of leisure and its impact on contemporary life; issues affecting recreation in today’s urbanized society.
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RTM 305 - Wilderness and the Leisure Experience
Units: 3 GE
Prerequisite(s): BIOL 100 or BIOL 101 .
Values of protected landscapes to individuals and society. Scientific, political, international, and ethical dimensions of natural landscapes. Implications for protection, visitor management, and sustainable tourism.
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RTM 340 - Conduct of Recreational Sports
Units: 3
Three lectures plus outside practical experience in the conduct of recreational sports programs.
Organization of competition, community sports programs, administration of intramural athletics, and techniques of officiating.
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RTM 351 - Recreation Therapy and Special Populations
Units: 3
Sociopsychological aspects of special populations and their implications for leisure pursuits. Field trips may be included.
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RTM 396W - Writing in Recreation Settings
Units: 3
Prerequisite(s): Satisfies Graduation Writing Assessment Requirement for students who have completed 60 units; completed Writing Placement Assessment with a score of 8 or higher (or earned a grade of C (2.0) or better in RWS 280 , RWS 281 [or LING 281 ] if score on WPA was 6 or lower); and completed General Education requirements in Communication and Critical Thinking. Proof of completion of prerequisite(s) required: Test scores or verification of exemption; copy of transcript.
Theory and practice of writing in the field of recreation and parks with application to various settings.
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RTM 404 - Cross-Cultural Perspectives of Tourism
Units: 3 GE
Concepts, definitions, and measures of essential cultural components of tourism. Integrated view of interrelated socio-cultural tourism issues with an understanding and appreciation of diverse cultures.
Note: This course satisfies the general education cultural diversity requirement.
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RTM 413 - Cultural Tourism
Units: 3
Two lectures and two hours of activity.
Prerequisite(s): RTM 470 .
Concepts of cultural tourism and cultural heritage management. Strategies for planning of cultural tourism resources and for development of cultural tourism initiatives. Evaluating tourism potential of cultural or heritage assets.
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RTM 468 - Marketing, Financing, and Assessment in Recreation and Tourism Management
Units: 3
Marketing, financing, and assessment specifically related to recreation and tourism management to include services development, pricing, promotion, distribution; budget development, revenue generation, assets management, controls; evaluation and research process as they relate to service development and delivery.
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RTM 469 - Administration and Operation of Recreation and Tourism Agencies
Units: 3
Prerequisite(s): RTM 470 or RTM 475 .
Administrative and operational aspects of managing and leading in recreation and tourism agencies to include liability, risk management, administrative regulations; information/decision systems in organizations; strategic planning; operation of facilities/areas; human resource functions related to successful service delivery.
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RTM 470 - Global Sustainable Tourism Management
Units: 3
Prerequisite(s): RTM 101 or HTM 201 .
Global tourism management, economics, development and sustainability. Social, cultural, and environmental impact indicators and management tools for sustainable development.
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RTM 475 - Commercial Recreation and Attractions Management
Units: 3
Analysis of commercial recreation field, including design, development, programming and marketing aspects of various commercial recreation enterprises.
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RTM 477 - Sustainable Tourism Planning
Units: 3
Prerequisite(s): RTM 101 .
Nature and scope of sustainable tourism planning. Approaches, principles, and processes for creating sustainability value in tourism. Sustainability assessment and corporate social responsibility for tourism amenities, attractions, services, transportation and facilities.
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RTM 483 - Outdoor Education and Camp Administration
Units: 3
Prerequisite(s): RTM 101 .
Philosophy, theory, methods, application, and scope of outdoor education in recreation and ecotourism camp settings. Management of resident, day, and travel camps.
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RTM 484 - Directed Leadership
Units: 3
Grading Method: Cr/NC
One lecture and eight hours of supervised activity.
Prerequisite(s): RTM 284 .
Supervised leadership experience in public and private recreation agencies. Maximum Credits: six units.
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RTM 485 - Outdoor Recreation Planning and Policy
Units: 3
Nature and scope of recreation in nonurban areas. Public demand for recreation and its impact on natural resources. Management, planning, research and operation of regional and national park and recreation areas.
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RTM 487 - Environmental and Cultural Interpretation
Units: 3
Prerequisite(s): RTM 101 .
Philosophy, theory, methods, application, and scope of cultural interpretation in recreation and tourism settings.
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RTM 489 - Outdoor Leadership and Adventure Programming
Units: 3
Prerequisite(s): RTM 305 .
Theoretical principles and experience in leadership, judgment, and decision making in outdoor adventure programming.
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RTM 496 - Experimental Topics
Units: 1-4
Selected topics. May be repeated with new content.
Note: See Class Schedule for specific content. Limit of nine units of any combination of 296, 496, 596 courses applicable to a bachelor’s degree.
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RTM 498 - Internship in Recreation and Tourism Management
Units: 6 or 12
Grading Method: Cr/NC
Twenty off-campus hours required per week for 6-unit program, or 40 off-campus hours required per week for 12-unit programs.
Prerequisite(s): Consent of instructor or department chair, completion of all required lower division recreation courses, and completion of both Standard or Multimedia First Aid certificate and CPR certificate by end of semester.
For six unit internship: 250 hours of professional work experience in recreation and tourism management. Maximum Credits: 12 units.
Note: For 12 unit internship: 500 hours required Credit for course requires completion of ePortfolio.
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RTM 499 - Special Study
Units: 1-3
Prerequisite(s): Consent of special study adviser.
Individual study. Maximum Credits: six units.
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Regulatory Affairs |
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R A 600 - Seminar
Units: 1-3
Prerequisite(s): Consent of graduate adviser.
An intensive study in specific areas of regulatory affairs. May be repeated with new content. Maximum Credits: six units applicable to a master’s degree.
Note: See Class Schedule for specific content.
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R A 601 - Pharmaceutical, Biotechnology, and Medical Device Industries
Units: 3
Introduction and foundational knowledge of biotechnology, medical device, and pharmaceutical industries. Commercialization- associated activities to include chemical synthesis, control, drug discovery, manufacturing, marketing, post-marketing surveillance, quality assurance, and regulatory affairs. Company organization and product development.
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R A 602 - Food and Drug Law
Units: 3
Prerequisite(s): R A 601 .
Laws and regulations enforced by the FDA for biotechnology, medical device, pharmaceutical, and related industries. Federal Food, Drug, and Cosmetic Act, Freedom of Information Act, related laws, and the U.S. legal system. Laws and regulations affecting biologics, cosmetics, devices and diagnostics, drugs, foods, tobacco products, and veterinary products. Combination products, import/ export requirements, international regulations, orphan products, and product liability.
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R A 605 - Medical/Scientific Writing for Life Science Professionals
Units: 3
Prerequisite(s): R A 601 .
Writing conducted during the development of a new biologic or drug. Effective writing of regulatory documents to include analyses of scientific literature for critical appraisal of drugs, informed consents, and reports of laboratory results.
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R A 696 - Advanced Topics in Regulatory Affairs
Units: 1-4
Prerequisite(s): Consent of graduate adviser.
Selected topics in regulatory affairs. May be repeated with new content.
Note: See Class Schedule for specific content. Credit for 696 applicable to a master’s degree with approval of the graduate adviser.
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R A 705 - Project Planning for the Biomedical Industries
Units: 3
Prerequisite(s): Graduate standing.
Introduction to strategies for effective management, planning, and scheduling of regulatory affairs activities and related tasks associated with project development in biomedical industries.
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R A 750 - Leadership for Change and Continuous Improvement
Units: 3
Prerequisite(s): Graduate standing.
Control and facilitation of change at a variety of levels within the biotechnology industry. Strategic improvements to increase competitive advantages. Process improvement concepts and methods, quality and statistical tools, and their applications to leadership, manufacturing, and production challenges.
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R A 770 - Current Good Manufacturing Practices - General Concepts
Units: 3
Prerequisite(s): R A 602 .
Interpretation and application of current Good Manufacturing Practices (GMPs) to drug substance and drug product manufacture. Differentiation between full and appropriate GMPs required for clinical supplies production and commercial manufacturing. Variances between FDA and European Union requirements for the control and manufacture of pharmaceuticals. Aseptic regulatory inspections processing and preparation.
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R A 772 - Post-Approval Activities
Units: 3
Prerequisite(s): R A 602 .
FDA and FTC rules and regulations governing advertising, labeling, and promotion for biologics, generic, over-the-counter, and prescription drugs; and medical devices. Annual reporting requirements, changes to approved marketing applications, Good Manufacturing Practice inspections, post-marketing adverse reaction reporting, product recalls, and risk management.
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R A 773 - Medical Device Regulations
Units: 3
Prerequisite(s): R A 602 .
Introduction to regulatory affairs requirements for the medical device industry through stages of product development. FDA medical device regulations, terminology, timelines, and actual steps followed by regulatory affairs professionals. Commercial, operational, and strategic aspects of the regulatory approval process for in vitro diagnostics (IVD) and medical devices. Marketing, regulatory intelligence, risk management, and strategic considerations Maximum Credits: combined credit six units of Regulatory Affairs 773 and R A 774 applicable to a master’s degree.
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R A 774 - Investigational and Marketing Applications for Drugs and Biologics
Units: 3
Prerequisite(s): R A 602 .
Content, planning, requirements, and strategy for developing and preparing Food and Drug Administration regulatory submissions to include biologics license applications (BLA), device premarket applications (PMA), device premarket notifications (510[k]), investigational device exemptions (IDE), investigational new drug applications (IND), new drug applications (NDA). Combination product submissions, future submission trends, and risk management. Maximum Credits: combined credit six units of R A 773 and 774 applicable to a master’s degree.
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R A 775 - Clinical Trials: Issues in Design, Conduct, and Evaluation
Units: 3
Prerequisite(s): R A 602 .
Issues in conduct, design, and evaluation of clinical trials by biotechnology, medical device, and pharmaceutical companies for marketing approval of products being studied in human subjects. Macro view of clinical trials within corporate, legal, and regulatory environments. Key steps required to develop and execute a successful clinical development program.
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R A 778 - Quality Control and Quality Assurance: Pharmaceuticals, Biologics, and Medical Devices
Units: 3
Prerequisite(s): R A 602 .
Quality and compliance functions in biotechnology and pharmaceutical companies to include out-of-specification results, developing product specifications, and writing compliant process deviations. Good Laboratory Practices (GLPs). Graded approach for Active Pharmaceutical Ingredients (APIs) manufacturing. Biologics, drugs, and medical device regulations. Quality control (QC) role vs. quality assurance (QA) role. Current trends in industry.
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R A 779 - International Regulatory Affairs
Units: 3
Prerequisite(s): R A 602 .
International medical device regulations to include those in the European Union and other key areas of the world that pertain to the development and commercialization of biologics, medical devices, and pharmaceuticals.
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R A 781 - Ethics for Life Science Professionals
Units: 3
Prerequisite(s): R A 602 .
Ethical issues confronting regulatory affairs professionals. Development of capacities to apply, generalize, and translate principles and ideas to modern biomedical practice. Responsible conduct surrounding clinical trials, human subjects, informed consent, institutional animal care and use, institutional review boards, trial design, and whistle blowing.
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R A 783 - Effective Communication for Regulatory Science
Units: 4
Prerequisite(s): R A 602 .
Advanced interpersonal, oral, and written communication strategies for the regulatory affairs business environment. Audience analysis, barriers to entry, and cultural considerations. Communication types to include e-mail communications, executive summaries, informational documentation, persuasive arguments, researchbased paper, and visuals for presentations. Culminating effort is capstone paper and presentation.
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R A 797 - Research
Units: 1-3
Grading Method: Cr/NC/RP
Prerequisite(s): Consent of graduate adviser.
Research in the area of regulatory sciences. Maximum Credits: six units applicable to a master’s degree.
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R A 798 - Special Study
Units: 1-3
Grading Method: Cr/NC/RP
Prerequisite(s): Consent of graduate adviser.
Individual study. Maximum Credits: six units applicable to a master’s degree.
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R A 799A - Thesis or Project
Units: 3
Grading Method: Cr/NC/RP
Prerequisite(s): An officially appointed thesis committee and advancement to candidacy.
Preparation of thesis or project for the master’s degree.
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R A 799B - Thesis or Project Extension
Units: 0
Grading Method: Cr/NC
Prerequisite(s): Prior registration in Thesis 799A with an assigned grade of RP.
Registration required in any semester or term following assignment of RP in Course 799A in which the student expects to use the facilities and resources of the university; also students must be registered in the course when the completed thesis or project is granted final approval.
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Religious Studies |
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REL S 100 - Exploring the Bible
Units: 3 GE
Basic content and themes of the Hebrew Bible and New Testament using methods of contemporary biblical studies. Attention to ancient Near Eastern and Greco-Roman cultural settings as well as the impact of the Bible on contemporary culture.
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