Regulatory Science Graduate Certificates

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Graduate Certificate in Medical Product Quality

The Graduate Certificate in Medical Product Quality is designed for students with a background in biological, pharmaceutical and biomedical sciences and biomedical engineering who seek to expand their expertise in the thriving sector of industry that oversees quality assurance and quality control. Students learn the essential tools that ensure the safety of drugs, biologics and medical devices in the United States and around the world, and how to apply this knowledge in the ever-expanding field of medical product development and manufacturing.

Graduate Certificate in Clinical Research Design and Management

The Graduate Certificate in Clinical Research Design and Management is an ideal training program for individuals interested in clinical research, either at a clinical site or in a medical products company. It is designed to strengthen the statistical, research and project-management skills of clinical researchers and their associated clinical team members. Students must complete at least 12 units of coursework including at least two courses in clinical design and trial management, one course in ethics and one course in a specialized aspect of design, management or statistics, subject to the approval of the program director.

Graduate Certificate in Food Safety

The Graduate Certificate in Food Safety meets a growing need for regulatory and safety experts in food and supplement industries. It is a 12-unit program of coursework designed to strengthen the knowledge base and functional “toolkit” of individuals who deal with the production and management of food in industry and government. Students are required to take an entry level course that focuses on regulatory requirements for foods and dietary supplements and two additional courses that focus on food science and food/ drug toxicology respectively. A final course will be selected from a small grouping of electives that deal with quality systems or risk management.

Graduate Certificate in Patient and Product Safety

The Graduate Certificate in Patient and Product Safety prepares risk managers and pharmacovigilence experts for professional careers where medical products and facilities have high risks that need to be anticipated and controlled. It educates students in the emerging field of safety and risk management to produce graduates with an expertise in the evaluation and mitigation of medical errors and health-care product problems. Participants in this highly focused program will take an introductory course in the basic principles of risk management, a second course in the use of risk management tools, and two additional courses in patient and product safety respectively.

Graduate Certificate in Preclinical Drug Development

The Graduate Certificate in Preclinical Drug Development is designed to provide advanced training for individuals interested in preclinical aspects of translational medicine and associated research. It prepares individuals for roles in preclinical and clinical affairs and early stage production. Students must complete at least 12 units of coursework including an introductory course, in translational medicine; two courses in drug discovery and development; and one course in a specialized aspect of development germane to translational science.

Graduate Certificate in Regulatory and Clinical Affairs

The Graduate Certificate in Regulatory and Clinical Affairs acquaints individuals with the world of medical product regulation, and prepares them for roles in regulatory and quality aspects of medical product development. Students must complete at least 12 units of coursework including an introductory course in regulatory affairs, at least one specialized course in regulatory management of a particular product type (drugs, devices or food), at least one course in clinical design and one course in quality systems or risk management.