Regulatory Affairs Curriculum

GW Health Sciences offers two graduate programs in the field of Regulatory Affairs:

MSHS in Regulatory Affairs

The online MSHS in the Regulatory Affairs (RAFF) requires successful completion of 36 semester hours, including: 6 semester hours of the research coursework, 9 semester hours of strategic leadership courses, 18 semester hours in the field of regulatory affairs, and 3 semester hours of electives.

Regulatory Affairs Courses (18 credit hours)

RAFF 6201: Introduction to Global Regulatory Affairs

This course will serve as a foundation for the entire program and is designed to provide students with a framework necessary to develop an integrated understanding of regulatory affairs. This course looks at the big picture, covering U.S. and international legislation and regulatory processes guidelines, as well as the pivotal role that regulatory affairs leaders play in developing products, navigating the regulatory review and approval process, and contributing to keeping products on the market. We are taking a journey that will bring us from early non-clinical investigations, through human clinical trials, manufacturing and testing up to launch, post-approval maintenance and promotional activities.

RAFF 6202: Regulatory Strategy in the Development of Drugs and Biologics

Focuses on the development and evaluation of global regulatory strategies that support drug and biologic product development. In this course we analyze the critical elements of the product life cycle in the determination of a regulatory strategy, asses 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.

RAFF 6203: Regulatory Strategy in the Development of Devices and Diagnostics

This course 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.

RAFF 6204: Clinical Research for Regulatory Affairs

Integration and synthesis of regulatory science 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 trials 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.

RAFF 6205: Regulatory Compliance

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 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).

RAFF 6275: Leadership and Change in Regulatory Affairs

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.

Graduate Research Courses (6 credit hours)

HSCI 6263 Biostatistics for Clinical and Translational Research

One learns a foundation in the 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-square analysis.

HSCI 6264: Epidemiology for Clinical and Translational Research

This course is designed to be a foundation of basic concepts and methods of epidemiology and their application in measuring, students utilize this course to study and improve the health of populations and learn of its applications for translational research.

Strategic Leadership Courses (9 credit hours)

HSCI 6240: Issues and Trends in Health Systems

You will examine clinical research and health care environments at the macro-level, which translates to identifying and examining the larger contemporary issues, trends, policies, and pressures that influence and shape current clinical research and health care practices.

HSCI 6241: The Health Care Enterprise

Develop a clinical research enterprise strategic plan, while analyzing business considerations, such as marketing, economic sustainability, fiscal management, quality improvement, and integrating technology. Through the development of a strategic plan, you will build an understanding of the intricacies of leading and managing a business unit. and management principles in assignments throughout the semester.

HSCI 6223: Topics in Health Care Leadership

Requires students to think critically about leadership concepts by analyzing and evaluating academic articles associated with leadership, change management and systems development. Topics in Healthcare Leadership is designed to use course content as a mechanism for developing critical thinking skills. This is a course that requires academic writing, contrasting and comparing and ideas, and extrapolating current literature into practical application. The focus is on thinking. While very structured, the course is not didactic in nature. This course is interdisciplinary and exposes students to other disciplines and worldviews that make up the health care sector in society, broadening the student’s overall perspective.

Elective Course (3 credit hours)

Transfer Credits

Up to six credit hours of previously earned graduate-level coursework may be accepted as transfer credit. Please contact the program office for the full policy and guidelines.

Official transfer credit evaluations are conducted only for admitted students.

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Graduate Certificate in Regulatory Affairs

The Graduate Certificate in Regulatory Affairs requires successful completion of 18 semester hours, including: 15 semester hours in the field of regulatory affairs and 3 semester hours Biostatistical course.

All semester credits earned in this program are transferable to the MSHS in Regulatory Affairs.

Regulatory Affairs Courses (15 credit hours)

 RAFF 6201: Introduction to Global Regulatory Affairs

This course will serve as a foundation for the entire program and is designed to provide students with a framework necessary to develop an integrated understanding of regulatory affairs. This course looks at the big picture, covering U.S. and international legislation and regulatory processes guidelines, as well as the pivotal role that regulatory affairs leaders play in developing products, navigating the regulatory review and approval process, and contributing to keeping products on the market. We are taking a journey that will bring us from early non-clinical investigations, through human clinical trials, manufacturing and testing up to launch, post-approval maintenance and promotional activities.

RAFF 6202: Regulatory Strategy in the Development of Drugs and Biologics

Focuses on the development and evaluation of global regulatory strategies that support drug and biologic product development. In this course we analyze the critical elements of the product life cycle in the determination of a regulatory strategy, asses 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.

RAFF 6203: Regulatory Strategy in the Development of Devices and Diagnostics

This course 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.

RAFF 6204: Clinical Research for Regulatory Affairs

Integration and synthesis of regulatory science 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 trials 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.

RAFF 6205: Regulatory Compliance

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 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).

Graduate Research Course (3 credit hours)

HSCI 6263: Biostatistics for Clinical and Translational Research

One learns a foundation in the 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-square analysis.

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Master of Engineering in Regulatory Biomedical Engineering

The Master of Engineering in Regulatory Biomedical Engineering (rBME) is an interdisciplinary program offered through the Department of Biomedical Engineering in partnership with the School of Medicine and Health Sciences. The program addresses an unmet need for a graduate program to train engineers in the specific set of skills of regulatory science, biomedical innovation, and entrepreneurship.

Students with training in engineering or physics and/or relevant industry/government experience study the fundamentals of biomedical engineering, global regulatory affairs, regulatory strategy in the development of devices and diagnostics, regulatory compliance, engineering patent law, medical measurements, and instrument design.

In addition to coursework, students gain experience in SBIR/STTR grant applications and/or FDA Premarket Notification (510(k)) submissions for medical devices.

For more information regarding on the curriculum and admission requirements, please visit the program page in the Department of Biomedical Engineering in the School of Engineering and Applied Science.

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