Fundamentals of Regulatory Affairs


The focus of this course was on the role of ethical clinical research and the regulatory process for new medical products. This course covered the origins and current status of laws and regulations as they pertain to the development, testing, commercialization, and total product life cycle for medical products. Submission documents that are required throughout the submission process were reviewed as well as the regulations that govern the conduct of clinical research, including study sponsors, investigators, and Institutional Review Boards.
  • Appraise the US and International Regulatory Systems and Agencies governing the commercialization of medical products and the conduct of clinical trials.
  • Analyze the structure of the Food and Drug Administration (FDA) and the functions of each major component of the organization.
  • Evaluate the regulatory impact of the CPSC, EPA, OSHA and state and local authorities, and the FCC and the FTC.
  • Discuss the conduct of ethical clinical research and the associated regulations during the product development process.
    Investigate the consequences of failure to comply with regulatory policies.
  • Compare and contrast the types of approvals and characteristics of each pathway for regulated products.
  • Analyze the importance of audits and the inspectional process and the subsequent reporting requirements.
  • Summarize the membership requirements, ethical obligations, and regulatory oversight of an Institutional Review Board.
  • Explain the role of FDA Advisory Committees in the review of products and in Agency policy decisions.
  • Defend the contribution of quality systems in each stage of product development and production.

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