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Clinical & Translational Science Institute / Education / Regulatory Science Training Programs

Regulatory Science Training Programs

The National Institutes of Health (NIH) and Food and Drug Administration (FDA) have launched a number of Regulatory Science and Translational Science programs to enhance the translation of research into products that benefit patients, while also improving the success rate of developing safe and effective medical products. The FDA defines Regulatory Science as “the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products.” More information on Regulatory Science is available here.

The CTSI has launched a range of programs focused on advancing training, career development and research in Regulatory Science:

Advanced Certificate in Regulatory Science

The CTSI, in partnership with the Department of Public Health Sciences, has created an advanced certificate in regulatory science 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. This NYS-approved certificate covers areas of experimental therapeutics, medical product innovation, ethics, biostatistics, FDA regulatory process, intellectual property, and science, technology and health policy.

America’s Got Regulatory Science Talent Competition

This annual student competition is an interactive and innovative approach to increase student awareness and interest in Regulatory Science.  Each year, winners of local competitions at the UR CTSI and the University of Maryland’s Center of Excellence in Regulatory Science Innovation present their ideas on how to address a set of regulatory science challenges in front of FDA leaders and scientists.  More information on the fifth annual competition is available here.

University of Rochester Broadening Experiences in Scientific Training (URBEST)

The NIH Broadening Experiences in Scientific Training (BEST) program is designed to develop innovative approaches to prepare students and postdocs for a range of careers. As part of the University of Rochester (UR BEST) Science and Technology Policy Pathway, trainees interested in the Regulatory Science and Personalized Medicine Track will learn key competencies in Regulatory Science and Personalized Medicine through internships and experiential opportunities that prepare them for careers at the FDA, NIH, Centers for Disease Control and Prevention (CDC), pharmaceutical and medical device industry, academic institutions and a range of other government agencies and NGOs.  Participants interested in the management and oversight of science can explore opportunities in the Regulatory Affairs Compliance and Review Pathway.

Career Development Program (KL2):  Regulatory Science Training Pathway

The CTSI Career Development Program (KL2) provides 2 years of support for the early career development of multidisciplinary clinical and translational scientists. The goal of the program is to promote the successful transition of KL2 scholars to an independent career as a clinical and translational investigator and includes three potential training pathways, including Regulatory Science.  In addition to providing core programmatic elements, individualized Regulatory Science elements include the Regulatory Science Certificate, specialized coursework, targeted internships or rotations, Regulatory Science modules, and access to advisors from FDA, industry, foundations and other relevant sectors. 

Independent Study Projects

Trainees interested in exploring independent study and research opportunities can also pursue a range of projects in areas at the intersection of translational science, regulatory science, policy, public health and medical product development.  If you are interested in an independent study or project, please contact Scott Steele or Joan Adamo.

PhRMA Foundation Pilot Program

The PhRMA Foundation is offering a pilot program to support scientists in an industry setting. The goal is that fellows will acquire the skills and multidisciplinary training required to succeed in regulatory science careers. One-year fellowships with $70,000 in salary support are being offered.

Application Deadline: April 1, 2018

Fellowships begin July 2018

Additional information and award details

For questions, contact: or 202-572-7756.