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Graduate Certificate in Regulatory Affairs: Curriculum

Curriculum Details

18 TOTAL CREDITS REQUIRED

The Graduate Certificate in Regulatory Affairs requires successful completion of 18 credit hours. You’ll explore topics such as the development of drugs and biologics, devices and diagnostics, clinical research in regulatory affairs, and regulatory compliance.

You can complete this graduate certificate in as little as two years and transfer all semester credits earned this program to the MSHS in Regulatory Affairs program also offered by GW.

Core

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.

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).

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