Informing regulatory decisions and improving public health
Developed in partnership with The University of North Carolina at Chapel Hill, Duke University, North Carolina Central University, North Carolina State University and the Burroughs Wellcome Fund
MPS in Regulatory Science
Interested in becoming a regulatory scientist? The Eshelman School of Pharmacy offers a fully online Master of Professional Science in Regulatory Science.
The U.S. Food and Drug Administration awarded $50M to the University of North Carolina at Chapel Hill and Duke University to establish the Research Triangle Center of Excellence in Regulatory Science and Innovation. The Center is the fifth one to be awarded and will also involve collaborations with North Carolina State University and North Carolina Central University. Working collaboratively with the FDA, our overarching goal is to serve as an accelerator hub to provide an abundance of essential new information, infrastructure, and tools to shorten the drug and device development process, to advance public health, and to inform FDA activities in ways that complement other CERSI's and contribute to achieving the goals of the national CERSI program.
New drugs, devices and technologies are constantly bursting onto the scene, aided by the use of artificial intelligence and other methodological innovations. For regulatory agencies, such as the FDA, keeping pace can be a challenge.
The Triangle CERSI unites the University of North Carolina at Chapel Hill, Duke University, North Carolina State University and North Carolina Central University – and the vast network of organizations and industries throughout the Research Triangle Park—to provide broad expertise and infrastructure for collaborations with the FDA where together, we’ll address the full spectrum of current and evolving needs in regulatory science.
Our capabilities in medical imaging, virtual twins and in silico trials, AI and machine learning methodologies, drug safety and pediatric clinical pharmacology coupled with our broad capabilities to address equitable race and gender representation within clinical trials will enhance the FDA’s understanding and assessment of risk and ensure continued safety and efficacy of products used by the public.
Showcasing the Triangle's Collective Strengths
We are delighted to be awarded the fifth national CERSI, which is a testament to the outstanding scientists at Carolina and Duke, along with our collaborating institutions NC State and NCCU. This center will support many joint research projects involving FDA scientists to better inform regulatory decisions and thereby improve public health.
The Triangle CERSI is a significant opportunity for our scholarly communities to curate and direct our intelligence towards addressing an important societal need for proficient and efficient regulatory approval and oversight.
There is no shortage of innovators working across our Triangle area research universities. As the newest CERSI, we can more directly partner with the FDA to apply our unique capabilities and strengths, such as the use of virtual twins, to ultimately speed and scale solutions toward making drugs, devices, the food supply, cosmetics and various other products more effective, safer and affordable.