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Advanced Certificate in Regulatory Science

Regulatory Science is defined by the FDA as “the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality and performance of FDA regulated products.” There is national recognition for the critical need of a cadre of professionals trained in Regulatory Science across academia, industry and regulatory agencies. 

Program Description

The advanced certificate in Regulatory Science is a multidisciplinary, cross-departmental graduate credential administered by the Department of Public Health Sciences (PHS) designed to produce a cadre of highly trained professionals able to contribute to the development of new medical interventions by enhancing the innovation, efficiency, and quality of the medical product development pipeline. 

Program Objective

To provide trainees with in-depth instruction in the fundamental skills, methodology, and principles necessary for a future career as a successful researcher/ scientist, reviewer, or other professional in academia, industry, government or other organization. This will build on the students existing expertise and training. The program is designed to meet these objectives through:

  • Didactic course work
  • A capstone project/competition
  • A mentorship program
  • Introduction to relevant career paths
  • Assistance in identifying experiential training opportunities

Educational Objectives

The program is competency-driven, based on a set of Regulatory Science core thematic areas and associated competencies that were developed collaboratively with a broad group of experts from academic institutions, government, industry and associations. Graduates are expected to have developed a strong foundation in Regulatory Science research questions, policy and priorities. This includes fundamental competencies in areas of:  regulatory policies and process, research ethics, drug discovery and development, medical device innovation, pre-clinical and clinical trials, analytical approaches, technology and innovation, and communication.


Required Courses Course Title When Offered Credits Completed
BME 431 FDA Regulatory Processes & Intellectual  Property Fall 2
BME 432 Navigating FDA Regulatory & Commercialization Landscapes Spring 2
PM 487 Fundamentals of Science, Technology & Health Policy Spring 2
PM 488 Experimental Therapeutics Fall 3
BST 463 Introduction to Biostatistics Fall 3
IND 501 Ethics in Research Fall 1

One or more of the following totaling at least 3 credits (sample graduate level courses, with others available upon approval):

Course ID Course Title When Offered Credits Completed
PHP 404 Principles of Pharmacology Spring 4
PM 415 Principles of Epidemiology Fall 3
BST 465 Design of Clinical Trials Spring 3
MBI 403 Drug Discovery Spring 2
IND 417 Workshop in Scientific Communication Spring 1

Additional Requirement

Participation in Capstone:            Regulatory Science Student Competition (Spring)

Click Here to Apply Department Site