Demonstrating the Effectiveness and Safety of New Medical Products Is a Critical Part of the Product Development Process. Clinical Trials and Regulatory Approval for New Medical Technologies Are Key Components of Successful Product Commercialization. This Course Discusses the Basics of Planning and Performing Clinical Trials Along with the Global Regulatory Framework.
Students Are Expected to Understand the Different Types of Study Design, Study Protocol Structure and Content as Well as the Requirements for Planning, Conducting and Completing a Clinical Trial. Students Will Also Gain Basic Knowledge of the Principles and Requirements of Worldwide Regulations That Govern the Design, Fabrication, and Maintenance of Medical Products.