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Graduate Certificate in Regulatory Affairs

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Understand Key Medical Advancements and Delivery

The online Graduate Certificate in Regulatory Affairs is an 18 credit-hour program offered through the George Washington University’s School of Medicine and Health Sciences to teach working professionals the relevant, critical skills and knowledge they need to become regulatory affairs leaders.

Developed in collaboration with regulatory affairs professionals in governmental agencies, including the Food and Drug Administration (FDA) and the National Institutes for Health (NIH), this program integrates global regulatory strategy across the curriculum to equip graduates as business leaders in regulatory strategy locally and abroad.

Who Should Apply to the Regulatory Affairs Graduate Certificate Program?

The certificate program is ideal for healthcare professionals who are either just entering the field of regulatory affairs or who wish to increase their knowledge and skills to advance to a leadership position.

Why Students Choose GW’s Online Regulatory Affairs Graduate Certificate?

  • Transferable to the Master’s Program: Opportunity to transfer all 18 credits and advance to the Master’s program.
  • Flexible Learning Environment: Flexible online program created for working professionals looking for career advancement.
  • Applied Curriculum: Hands-on curriculum designed by industry experts in research, development and healthcare regulation.
  • Extensive Networking Opportunities: Immersed in a rich, global network of professionals who are actively shaping regulatory policy.
  • Global Perspective: Multi-faceted program with foundations in both domestic and international regulatory affairs.
  • Interdisciplinary Approach: Built on the combined practices from law, science, and business in regulatory strategies.
  • Practitioner Faculty: Students learn from experienced governmental officials and renowned industry leaders.

Click here to see what GW’s students have to say about the Regulatory Affairs program.

What Will I Learn?

Graduates of the online Graduate Certificate in Regulatory Affairs program will gain the skills to advance their knowledge in the areas of clinical research, product testing, global health and public health policy.

As a graduate of the certificate program, students will be fully prepared to:

  • Understand the framework necessary to develop an integrated understanding of regulatory affairs
  • Demonstrate knowledge of development and evaluation of global regulatory strategies that support drug and biologic product development.
  • Examine the regulation of medical devices through an epidemiological lens
  • Understand topics such as protocol development, study design, post-marketing surveillance, evaluation and assessment of regulatory submissions

Gain an Integrated Understanding of Regulatory Affairs

Students of the online Graduate Certificate program in Regulatory Affairs will learn to evaluate the scientific and economic value of potential new products in the global market, championing effective deliveries of healthcare products locally and abroad.

By combining interdisciplinary practices of law, science, and business in regulatory affairs, the graduate certificate program prepares students for a variety of careers in regulatory affairs. Typical roles for regulatory affairs professionals include:

  • Regulatory Affairs Associate
  • Regulatory Affairs Specialist
  • Compliance Specialist
  • Associate Technical Engineer
  • Quality Manager

Click here to learn more about a career in Regulatory Affairs.

Graduate Certificate in Regulatory Affairs Curriculum (18 Credit Hours)

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

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

Advance Your Career as a Leader in Regulatory Affairs

Contact an admissions advisor today at (844) 386-7323 or click here to request more information.