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You are here: Home / MSRA Degree Learning Outcomes

MSRA Degree Learning Outcomes

Student who successfully complete the Master of Science degree in Regulatory Affairs should be able to do the following:

  • Interpret existing United States healthcare-related laws, regulations, guidelines, guidances, and policies pertaining to the development of pharmaceutical and medical device products;

  • Evaluate the multifaceted research and development process for pharmaceutical, biologic and medical device products from an FDA regulatory perspective;

  • Assess the impact and identify critical areas of compliance with quality-related regulations and policies, e.g., Good Laboratory Practices, Good Clinical Practices and current Good Manufacturing Practices, for research, development, manufacture and commercialization of regulated healthcare products;

  • Interpret the impact of FDA-related laws and regulations on activities of other key areas of research and development, e.g., clinical research, quality control, quality assurance, and validation;

  • Identify the key specific areas of responsibility of the regulatory affairs professional that extend throughout the lifetime of each healthcare product;

  • Research and identify international healthcare regulations and apply them in the planning of a pharmaceutical or medical device development program;

  • Utilize effective communication skills based on organizational behavior and project and operations management principals within a project development team environment in the pharmaceutical, biotechnology and medical device industries;

  • Interpret, summarize, and explain requirements for FDA submissions to test investigational drugs, biologics, and medical devices with human subjects; and

  • Interpret, summarize, and explain the main sections of a new drug application, a biologics license application, and a premarket application and notification

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