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Regulatory Affairs Courses – MSHS in Regulatory Affairs

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Understand the Delivery of Key Medical Advancements

The George Washington University (GW) offers online Regulatory Affairs courses developed in collaboration with regulatory affairs professionals and governmental agencies, including the Food and Drug Administration (FDA). The program’s advisory board provides diverse, contemporary perspectives from different facets of the device and pharmaceutical industries, creating a valuable network for GW students and graduates.

GW’s online Master of Science in Health Science (MSHS) in Regulatory Affairs program consists of 36 credits hours to be completed over two years. The graduate certificate in Regulatory Affairs consists of five core courses and one research course and can be completed in two years.

Online Regulatory Affairs Graduate Program Curriculum

Major Courses

Credits

RAFF 6201

Introduction to Global Regulatory Affairs

3

RAFF 6202

Regulatory Strategy in the Development of Drugs and Biologics

3

RAFF 6203

Regulatory Strategy in the Development of Devices and Diagnostics

3

RAFF 6204­

Clinical Research for Regulatory Affairs

3

RAFF 6205

Regulatory Compliance

3

RAFF 6275­

Leadership and Change in Regulatory Affairs

3

Research

HSCI 6263

Biostatistics for Clinical and Translational Research

3

HSCI 6264

Epidemiology for Clinical and Translational Research

3

Professional

HSCI 6223

Topics in Health Care Leadership

3

HSCI 6240

Issues and Trends in Health Systems

3

HSCI 6241

The Health Care Enterprise

3

Elective

Chosen with Academic Advisor

3

Total

36

Darker tan denotes graduate certificate required courses

Curriculum

Major Courses (18 Credits)

RAFF 6201 – Introduction to Global Regulatory Affairs

Serves 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. It 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. 

Learning Objectives:

  • Analyze regulatory affairs principles, science and strategy
  • Analyze key elements of the regulatory processes and the factors that impact regulatory affairs
  • Demonstrate critical thinking skills in academic writing and group discussion
  • Apply and synthesize regulatory affairs practice into professional application

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

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.

Learning Objectives:

  • Analyze and evaluate the principle components of global regulatory strategies for drugs and biologic products
  • Evaluate critical elements of the product life cycle in the determination of a regulatory strategy
  • Assess the roles of non-clinical data in determining regulatory strategy
  • Appraise approaches for integrating strategic business needs into regulatory planning
  • Evaluate the role of post-marketing efforts in shaping regulatory strategy

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

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.

Learning Objectives:

  • Analyze and evaluate the principle components of global regulatory strategy for devices and diagnostics
  • Examine the regulation of medical devices through an epidemiological lens
  • Analyze essential considerations associated with specific classifications or specialty areas of medical devices

RAFF 6204 – Clinical Research for Regulatory Affairs

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 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.

Learning Objectives:

  • Analyze and evaluate regulatory guidance in shaping regulatory strategy, study design and protocol development and safety monitoring
  • Synthesize and integrate post marketing data to inform research questions and clinical research practice for purposes of safety and efficacy
  • Compare and evaluate key therapeutic markers across targeted therapeutic categories
  • Analyze and assess regulatory strategy across therapeutic categories

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 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).

Learning Objectives:

  • Analyze and evaluate regulatory policy and guidelines for compliance in medical product development and use
  • Integrate and develop implementation strategies for insuring regulatory affairs compliance in medical product manufacturing, development, labeling and marketing
  • Analyze and evaluate regulatory compliance issues across product categories

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.

Learning Objectives:

  • Assess theoretical constructs of change management and links to complexity theory
  • Differentiate the critical elements for successful outcomes in organizational and process change
  • Demonstrate effective communication skills using a variety of written, verbal and electronic formats
  • Demonstrate the ability to conceptualize and synthesize information and knowledge as a key component of critical thinking and decision-making
  • Develop a proposal for initiating a key strategic change initiative within the field of major for graduation
  • Develop interdisciplinary team work with colleagues focused on patient-centered care, evidence-based practice, utilization of informatics and research data and quality improvement within health systems 

Research Courses (6 credits)

HSCI 6263: Biostatistics for Clinical and Translational Research

Provides an introduction to the foundation of biostatistics, which is comprised of the design and analysis of clinical research. Topics include distributions, populations and sample selection, variables, interaction and confounding, hypothesis formulation, correlation, t-tests, ANOVA, regression and chi-square analysis. In addition, the course will examine the interpretation of output from statistical software (SPSS and SAS). Practice problems and review of scientific literature are also included to provide a comprehensive context in public health.

Learning Objectives:

  • Evaluate data sources and data quality for the purpose of selecting appropriate data that suit specific research questions
  • Discuss basic principles and the practical importance of key concepts, namely: probability, distribution, measures of central tendency, inductive and deductive reasoning, hypothesis testing, significance level, confidence interval, power, errors of type I and type II, threats to validity and confidence intervals
  • Apply numerical, tabular and graphical descriptive techniques commonly used to characterize and summarize public health data
  • Transform research objectives into clear, testable statistical hypotheses
  • Select appropriate statistical methods to be applied in a given research setting and acknowledge the limitations of those methods
  • Compare two or more groups of data using both parametric and non-parametric statistical methods
  • Present a research idea in a written proposal

HSCI 6264: Epidemiology for Clinical and Translational Research

Provides an introduction to the way epidemiologists explore individual characteristics and their influences on public health, identify risk factors and health disparities of disease and provide information for preventive medicine through the use of descriptive studies, surveillance and analytical studies. The basic concepts and methods of epidemiology and their application in measuring, studying and improving the health of populations are discussed.

Learning Objectives:

  • Develop a population-based perspective of disease and other health-related events
  • Calculate and interpret measures of disease frequency, morbidity and mortality
  • Compare, contrast and describe appropriate applications of the major types of epidemiologic study designs
  • Examine association and cause-effect relationships between risk factors and specific diseases and conditions
  • Evaluate strengths and limitations of epidemiologic studies
  • Assess effects of bias and confounding in published epidemiologic literature
  • Discuss the impact of epidemiology on public health policy and programs
  • Evaluate ethical and legal issues in epidemiologic research
  • Articulate the value of multidisciplinary research in addressing public health problems
  • Apply epidemiologic concepts in the context of translational research 

Professional Courses (6-9 credits)

HSCI 6223: Topics in Health Care Leadership

Allows students to think critically about leadership concepts by analyzing and evaluating academic articles associated with leadership, change management and systems development. Course 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.

Learning Objectives:

  • Develop an understanding of the organizational leadership literature and theories
  • Apply leadership principles in the solution of a personal leadership and organizational dilemma/challenge
  • Explain relationships that exist between culture and leadership
  • Identify your own, personal leadership philosophy and style
  • Relate leadership theory to the health care enterprise
  • Identify strategies available for developing leadership qualities in others
  • Explain how leadership relates to learning

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.

Learning Objectives:

  • Analyze the structure and organization of the US healthcare system
  • Differentiate and describe the major forms of health care delivery in the US
  • Evaluate and critique the major legal, ethical and applied bioethical issues and their impact on health care delivery and the research enterprise
  • Examine and differentiate conflict of interest issues from personal, organizational and policy perspectives
  • Review the structure and roles of the legislative, executive (regulatory) and judiciary branches of the US government and outcomes relevant to health policy development
  • Analyze the implications of federal, state and local budget considerations in health policy formulation and implementation
  • Analyze strategies that can influence health policy, including interest groups, grassroots campaigns, use of research and the media
  • Compare and contrast current and emerging health policy issues and assess various stakeholder positions on those issues
  • Given an issue that needs to be addressed within the health care system, formulate a policy analysis within the cost quality access model to influence and improve a health care system

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.

Learning Objectives:

  • Develop a strategic plan
  • Develop and promote a healthcare enterprise mission and purpose
  • Apply financial principles in strategic business decision-making and evaluation
  • Apply marketing strategies towards the cultivation of a customer and stakeholder base
  • Relate organizational theory and practice in order to integrate the various facets of the enterprise into a coherent "organizational enterprise"
  • Utilize information and quality improvement to further develop strategic, analytical and critical thinking skills
  • Develop strategies for successfully embracing the legal and regulatory influences in the healthcare environment
  • Develop critical thinking, analytical capabilities and creative insights that support leadership development in the context of environmental changes affecting the health care enterprise

Elective Course (3 credits)

You can discuss which elective course fits your career outlook best with an Academic Advisor.

Summer Institute:

For students interested in an international, multi-disciplinary program organized through collaborations between the George Washington University School of Medicine and Health Sciences and the European Center of Pharmaceutical Medicine (ECPM) at the University of Basel, Switzerland, click here to learn more.

Click here or call (844) 386-7323 to request more information about GW’s online MSHS in Regulatory Affairs curriculum.