2021 Global Conference on Regulatory Science Proceedings Available Now!
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Improving the Process of Therapeutic Development

Harvard, MIT, and the FDA have partnered to create a center focused on regulatory science, bringing together a range of scientific disciplines that are applied to assess the quality, safety and efficacy of medicinal products and inform regulatory decision-making throughout the lifecycle of a medicine. Working across academia, industry, and government institutions, the Center promotes regulatory science through research and education programs, uniting stakeholders under a common mission: promoting optimal patient health outcomes through biomedical innovation and the availability of safe and effective diagnostics and treatments.

The Urgent Need for Research Coordination to Advance Knowledge on COVID – 19 in Children

Bourgeois, Florence T., Paul Avillach, and Mark A. Turner, 2021

De Novo Powered Air – Purifying Respirator Design and Fabrication for Pandemic Response

Kothakonda, Akshay, Lyla Atta, Deborah Plana, et al. 2021

Quantifying the Feasibility of Shortening Clinical Trial Duration Using Surrogate Markers

Wang, Xuan, Tianxi Cai, Lu Tian, et al. 2021

The Regulatory Science Fellowship Program

Our fellowship program is affiliated with the FDA and focuses on training the next generation of regulatory science researchers. Learn more about the research our fellows are conducting or explore opportunities and how to get involved in our program.

News, Events, & Updates

RegSci Forum “Fellows Showcase”

CRS Fellows | February 1, 2021 12:00 – 1:00pm ET

Innovators in Therapeutics Speaker Series

Dr. Vas Narasimhan | February 8, 2021 11:30am-12:30pm ET

Twitter @Harvardmit_CRS

Harvard-MIT Center for Regulatory ScienceFollow

Michael S. Sinha, MD JD MPH @DrSinhaEsq·

11 Jan

Great to have @jsross119 @YaleMed @Yale_CRIT join the @HarvardMIT_CRS #RegSci forum to discuss "Use of Real-World Data and Evidence for Medical Product Evaluation: Promise and Perils"

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NHLBI Small Business @NHLBI_SBIR·

5 Jan

Are you an entrepreneur interested in accelerating medical device innovation with #RegulatoryScience tools? Attend Part I of the webinar series on January19th! Register now: https://bit.ly/31XfONX

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Harvard-MIT Center for Regulatory Science @HarvardMIT_CRS·

4 Jan

Please join us for the first RegSci Forum of 2022 with Dr. Joseph Ross, Professor of Medicine and Public Health at Yale University. Register now: https://bit.ly/3sRqw3M

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Florence Bourgeois @ftbourgeois·

21 Dec

Check out our latest via @JAMAPediatrics highlighting continued need to ensure judicious and evidence-based use of controlled substances in adolescents and young adults.

https://jamanetwork.com/journals/jamapediatrics/fullarticle/2787010
@therealMikeToce @chip @HarvardMIT_CRS

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Harvard-MIT Center for Regulatory Science @HarvardMIT_CRS·

17 Dec

Season's greetings from the Harvard-MIT Center for Regulatory Science!

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