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ACR634

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Clinical Risk Management and Safety

Applied Education in MedTech IndustryGraduateCollege of Science and Engineering

Course Outline

Risk management and safety regulations. 10% Regulatory and quality compliance. 10% Regulatory reporting requirements. 10% Clinical evidence in risk management. 10% Clinical trial independent oversight and advisory committees. 10% Quality management systems. 10% Corrective and preventive actions (CAPA). 10% Regulatory inspections and audits. 10% Clinical trial monitoring. 10% Clinical trial registration (clinicaltrials.gov). 10%