About the Graduate Certificate in Regulatory Sciences Program

Regulatory Sciences Students with their Certificates

In the Regulatory Sciences Certificate courses, you will gain insight into the laws, regulations, policies, and processes, and application of the underlying scientific knowledge that go into FDA decision-making. You will obtain a working knowledge of regulatory science that can foster leadership in industry, government, or academia. Graduates from the program acquire a competitive background for regulatory science-based careers.

In order to serve the global needs for enhanced regulatory science education, we offer a fully online program that is accessible worldwide. This program is offered at the same low cost to all students, whether they are based in the U.S. or abroad. Students can login to classes at any time of day from any location. The program can be completed in one-year by taking two courses a semester, with flexibility for a two-year option by taking one course per semester.

Learning Objectives

  • Develop a broad understanding of the regulatory framework of the U.S. Food and Drug Administration, including administrative structure and legislative mandate.
  • Become familiar with the various regulations that govern development of new drugs, medical devices, cosmetics, and food ingredients and how they are tested and approved for commerce.
  • Develop the critical skills needed to assess and apply basic science for regulatory decision—making.
  • Develop an understanding of the types of scientific data required for product safety assessment and product approval.
  • Master risk assessment/product safety assessment methods and skills that contribute to how scientific data from animal testing are used to predict human risk.
  • Master risk assessment/product safety assessment methods and skills 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 the data quality requirements for scientific studies submitted in support of regulatory decisions, specifically GLPs, GCPs, GMPs.