Title | Winter | Spring | Summer | Fall |
Regulatory Requirements for Medical Devices (3.00 Units)
EECS X445.2
Increase your understanding of the essential U.S. medical device regulations, including device classification, organizing pre-market notification 510(k), and planning and submitting a Pre-market approval (PMA). Enhance your knowledge of topics that include: global vigilance requirements and labeling requirements, European Medical Device Directive 93/42/EEC (MDD), E.U. conformity assessments, meeting E.U. essential requirements, and developing a technical file for the E.U. Get a review of device registrations in Canada, Australia, Japan and Latin America.
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to be scheduled
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Online
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to be scheduled
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EECS X445.2 OR EECS X445.26
EECS X445.2 OR EECS X445.26
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Regulatory Requirements for Pharmaceutical Products (3.00 Units)
EECS X445.26
This course presents a detailed overview of the regulatory requirements for the discovery, development, and commercialization of pharmaceutical products (drugs and biologics). Individuals involved in manufacturing, quality control, research and development, and clinical studies will learn the latest information. Explore topics that include the product development process through commercialization, product characterization and pre-clinical evaluation, pharmaceutical industry requirements, clinical trial requirements, good manufacturing practices (GMPs), good laboratory practices (GLPs) and inspections, labeling medical products and writing Food and Drug Administration (FDA) submissions.
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Online
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Online
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to be scheduled
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Fundamentals of Clinical Trials (3.00 Units)
BIO SCI X450
Clinical trials are designed to answer questions concerning the safety and effectiveness of medical products. Get an overview of clinical trials regulated by the FDA. Learn about the planning process underlying the Strategic Clinical Plan and regulatory submissions to the FDA. Explore topics including protocol development and implementation, i.e., study site selection, financial controls, timelines, and management of the site's operations; proper informed consent; Good Clinical Practices compliance; HIPAA; FDA regulations and guidelines; and post-market support studies.
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to be scheduled
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Online
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Application of Good Clinical Practices (3.00 Units)
MED X413.4
Gain an understanding of the accepted good principles and practices applicable to the development and implementation of drugs and medical devices in a research environment. Enhance your knowledge of topics including: definition of GCPs; the affect of GCPs on the conduct of a clinical trial; applicable regulations from ICH, HHS, FDA, and the state; obligations of investigators, sponsors, monitors, SMOs, CROs, and IRBs in a research engagement; and compliance and accountability during a clinical trial. Learn about the basic elements of the clinical data management process.
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to be scheduled
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Human Subjects Safety in Clinical Trials (2.00 Units)
BME X430
The use of human subjects in clinical trials for drug and device development requires sound ethical practices. Explore topics that include FDA regulations and guidance, informed consent process, the make-up and function of Institutional Review Boards (IRB), the IRB review process, and basic biomedical ethics. Course topics are enhanced by case studies, small group discussions, and research document reviews.
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to be scheduled
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