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  • RGAF 6000: Intro to Regulatory Affairs

    3.00 Credits
    Weber State University

    This course is designed to present an introduction to the regulations, documents and processes necessary for FDA approval of new medical products. The course covers an overview of critical scientific, technical, engineering design, manufacturing, and operational drivers for national and global regulatory compliance. This course also discusses the historical context in which the FDA evolved, its structure and relationship with other US regulatory agencies. The course will provide an overview of market clearance pathways for various medical products and devices that ensure the development and delivery of safe and effective healthcare products to consumers.
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  • RGAF 6100: Biostatistics Applied Research

    3.00 Credits
    Weber State University

    Advanced biostatistics as applied to research. The concepts of populations, samples, distributions, variables, hypothesis formulation and testing, t-test, ANVOA, and chi-square are presented through the lens of translational research. The course includes a detailed exploration of the application and interpretation of data from clinical trials and medical studies. The written and oral communication of study results is also covered.
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  • RGAF 6200: Regulatory Drugs & Biologics

    2.00 Credits
    Weber State University

    This course focuses on the development and evaluation of regulatory practices related to drugs and biologics. This course provides an overview of laws and regulations governing development, manufacturing and distribution of drugs and biologic and how they relate to the regulatory affairs strategy. Approaches for integrating regulatory and business needs are reviewed. The role of post-marketing efforts in shaping regulatory strategy are evaluated. Prerequisite:    RGAF 6000
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  • RGAF 6230: Regulatory Devices/Diagnostics

    2.00 Credits
    Weber State University

    An in-depth exploration of the origins and application of regulations relevant to medical devices and diagnostics. Medical device and diagnostic product development is covered through an organizational strategy and regulatory compliance lens. The course analyzes the design and application of clinical trial data related to the medical device and diagnostic regulatory process. Post-marketing strategy and device labeling are also covered. Prerequisite:    RGAF 6000
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  • RGAF 6250: Regulatory Clinical Evidence

    2.00 Credits
    Weber State University

    The evaluation and assessment of regulatory strategies that include protocol development, study design, post-marketing surveillance, evaluation and, assessment of regulatory submissions. Utilizing clinical trial design, participants will evaluate and assess strategies for achieving regulatory goals. Students are introduced to requirements of planning and conducting clinical trials. Clinical trial terminology and design are discussed including planning and carrying out a study. Prerequisite:    RGAF 6000
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  • RGAF 6300: Compliance Regulatory Affairs

    3.00 Credits
    Weber State University

    This course focuses on regulatory affairs compliance strategies and guidelines. Topics included are regulatory compliance, risk management, bioethics, quality assurance, and required reporting. Students will 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 develop implementation strategies for ensuring regulatory affairs compliance in medical product manufacturing, development, and marketing. Students will need to demonstrate effective written communication skills required to develop regulatory communications using root cause analysis and corrective and preventive actions (CAPAs). Prerequisite:    RGAF 6000
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  • RGAF 6500: Internship

    3.00 Credits
    Weber State University

    The internship course will focus on research and application of regulatory issues in the organizational agency of their choice. Application of knowledge and skills of regulatory science through participation in a part or full time internship with a biomedical related industry or agency. Internship competencies will be determined by the student and preceptor based on organization focus and student need. The internship is arranged by the student, faculty, and participating institution by mutual consent. Prerequisite:    RGAF 6000
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  • RHS 1300: First Aid: Resp to Emergencies

    2.00 Credits
    Weber State University

    Trains the lay person to respond correctly in emergencies and act as the first link in the emergency medical service system. Course leads to American Heart Association Basic Life Support (BLS) and Heartsaver First Aid OR American Red Cross certification in Adult, Infant and Child CPR with AED and First Aid: Responding to Emergencies.
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  • RHS 1550: Intro Rehabilitation Sciences

    2.00 Credits
    Weber State University

    This course is designed to introduce students to health care professions that the majority of athletic therapy majors pursue. These health care professions include: athletic training (AT), physical therapy (PT), occupational therapy (OT), physician assiatant (PA), and medicine (MD or DO). Through lecture and assignments, students will learn the process to apply for the gradaute school of their choice and learn skills and perform activities to get them ready for graduate school.
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  • RHS 2175: Intro to Sports Medicine

    3.00 Credits
    Weber State University

    Presents the duties, functions, and collaboration of sports medicine professionals in the care and supervision of athletes. The course will focus on the prevention, diagnosis, and treatment of common musculoskeletal injuries/illnesses, strength and conditioning of athletes, environmental factors and guidelines, and management and administration of the sports medicine team.
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