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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.

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

Advanced Certificate in Regulatory Science

The UR 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. 

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 UR 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.

Tobacco Centers of Regulatory Science

One of only nine proposals to earn funding through the NIH and FDA Tobacco Centers of Regulatory Science (TCORS) program, the WNY Center for Research on Flavored Tobacco Products, or CRoFT, has united teams from Roswell Park Comprehensive Cancer Center and the University of Rochester Medical Center in an effort to better document and understand one of the fastest-growing trends in tobacco use. As part of CRoFT, the Career Enhancement Core led by Scott Steele, Ph.D. and Deborah Ossip, Ph.D. is developing a broad range of research and training activities that will build and improve expertise in Tobacco Regulatory Science (TRS).

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 Joan Adamo.

PhRMA Foundation Pilot Program

The PhRMA Foundation is offering three award programs to support scientists in an industry setting:

Application Deadline: The 2021 application cycle is closed. Please check back in December 2021 for information on the 2022 application cycle.  

For questions, call (202) 572-7756.

Innovation in Regulatory Science Award

The Burroughs Wellcome Fund's Innovation in Regulatory Science Award provides up to $500,000 over five years to academic investigators developing new methodologies or innovative approaches in regulatory science that will ultimately inform regulatory decisions.

Application Deadline: The Innovation in Regulatory Science Award will be offered again in 2023.