MSHS in Regulatory Affairs: Curriculum

Students examine leadership/leadership change theories in the healthcare industry setting, as well as management and communications strategies, and values in a systems framework. Theories and styles of leadership, including organizational management and values, strategic planning, communication strategies, managing change, and negotiating conflict in the context of the health care delivery system.

Students examine the major themes on healthcare policies, trends, and issues in the major health systems and research enterprise Students apply epidemiologic concepts in the context of translational research.

An overview of global business principles related to health care systems: the management of patient-centered care delivery, marketing, finance and fiscal management principles, information technology, and quality improvement.

Basic concepts and methods of biostatistics applied to translational research. Topics include distributions, populations and sample selection, variables, interaction and confounding, hypothesis formulation, correlation, t-tests, ANOVA, regression, and chi.

Students explore the basic concepts of epidemiology which includes various epidemiological study designs used to examine disease frequency, cause-effect relationships between risk factors and disease states, and effects of bias as examples. Students apply epidemiologic concepts in the context of translational research.

Foundations of regulatory affairs, including U.S. and international legislation and regulatory processes guidelines. Roles of leaders of regulatory affairs in developing products, navigating the regulatory review and approval process, and contributing to keeping products on the market.

Development and evaluation of the regulatory affairs strategies that support drug and biologic development. Research science, study design, master file, risk/benefit analyses, product specifications and milestone identification, IND and NDA.

Development and evaluation of the regulatory affairs strategies that support device and diagnostics development. Research science, study design, master file, risk/benefit analyses, product specifications and milestone identification, IDE, 510K, PMA.

The planning and conduct of clinical trials. Topics include protocol development, study design, post-marketing surveillance, and evaluation and assessment of regulatory submissions. Strategies for achieving clinical development goals.

Analysis and evaluation of regulatory affairs compliance strategies and guidelines. Pre and post marketing compliance of medical products, oversight, labeling, advertising and use.

Theories of leadership and change are integrated in the development of change proposals for the regulatory affairs field. The development of leadership solutions to problems in leading regulatory strategic change; integration of all field coursework into implementation plans for health care system changes.

One of the following:
CML 6274 Health Economics and Finance
CRA 6203 Partnerships with Human Subjects
CRA 6208 International Clinical Research
CRA 6209 Quality and Risk Management
CRA 6210 Medical Writing/Clinical Research
HCQ 6201 Building a Quality Culture
RAFF 6206 International Regulatory Affairs
RAFF 6207 Advertising and Promotion of Regulated Medical Products