36 TOTAL CREDITS REQUIRED
The online MSHS in Regulatory Affairs program consists of 11 core courses and one elective for a total of 36 credits.
The curriculum was designed in collaboration with regulatory affairs professionals who work in the industry and government agencies, including the FDA.
This program is 100% online, features no on-campus residencies, and you can graduate in just 24 months part-time.
Students examine leadership/leadership change theories in the healthcare industry setting, as well as management and communications strategies, and values in a systems framework Students examine topic areas such as populations, sample selection, variables, hypothesis formulation, correlation, t-tests, ANOVA, regression, and chi-square analysis. Students examine output from statistical software (SPSS and SAS), practice problems and reviews of scientific literature through assignments such as a research analysis plan.
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.
Covers the development and evaluation of global regulatory strategies that support drug and biologic product development In this course students analyze the critical elements of the product life cycle in the determination of a regulatory strategy, assess the roles of non-clinical and clinical data in determining regulatory strategy, appraise approaches for integrating strategic business needs into regulatory planning and evaluate the role of post-marketing efforts in shaping regulatory strategy.
Provides a framework for the development and evaluation of the regulatory affairs strategies that support device and diagnostics development Objectives for this course are to analyze and evaluate the principle components of global regulatory strategy for devices and diagnostics, examine the regulation of medical devices through an epidemiological lens and analyze essential considerations associated with specific classifications or specialty areas of medical devices.
This course sources in the evaluation and assessment of regulatory strategies. Topics include protocol development, study design, post-marketing surveillance, evaluation and, assessment of regulatory submissions. Through the framework of clinical trial design, we evaluate and assess strategies for achieving regulatory strategy in clinical development goals. The course introduces students to the planning and conduct of clinical trials. It provides an overview of clinical trial terminology and discusses issues related to clinical trial design. It discusses the components of a clinical trial including considerations regarding planning and carrying out a study. In the course we evaluate alternative clinical trial design options as conduits for achieving regulatory approval.
This course focuses on the analysis and evaluation of regulatory affairs compliance strategies and guidelines. Topics include pre- and post-marketing compliance, labeling, advertising and required reporting In this course we identify and assess regulatory requirements, policies and guidelines associated with good practice (GXP) regulatory compliance issues. Students are required to critically analyze regulatory compliance issues and to integrate and develop implementation strategies for ensuring regulatory affairs compliance in medical product manufacturing, development, labeling and marketing. Students will need to demonstrate their ability to craft written regulatory communications including root cause analysis and corrective and preventive actions (CAPAs).
Theories of leadership and change are integrated in the development of change proposals for the regulatory affairs field. This is a capstone course focusing on the concept of leading change within the contexts of health professionals, health systems and health policy. Organizational, management and change theories, as well as characteristics of personal and professional change leadership, are explored in relation to expectations for successful executive leadership and performance in today’s dynamic health care environments.
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
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