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Certificate in Regulatory Science Program Competencies

  • Develop a broad understanding of the regulatory framework of the U.S. Food and Drug Administration, including the administrative structure and legislative mandate of the agency.
  • Become familiar with the various regulations that govern development of new drug, medical devices, cosmetics, and food ingredients and how they are tested and approved for commerce.
  • Develop a deeper appreciation of the types of scientific data that are required for product safety assessment and product approval.
  • Learn risk assessment/product safety assessment methods that contribute to how scientific data from animal testing are used to predict human risk.
  • Master risk assessment/product safety assessment methods applicable to the collection of and utilization of human data that can be used to estimate and predict population risk.
  • Understand the regulations that govern clinical drug trials and how clinical trials are designed and managed for new drug approval.
  • Become knowledgeable of data quality requirements for scientific studies submitted in support of regulatory decisions.
  • Develop the critical skills needed to assess and apply basic science for regulatory decision-making.