Global Conference on Regulatory Science (October 11-12, 2022)
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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

Improving FDA Postmarket Adverse Event Reporting for Medical Devices

Wunnava, Susmitha, Timothy A. Miller, and Florence T. Bourgeois, 2022

Risks to the 340B Drug Pricing Program Related to Manufacturer Restrictions on Drug Availability

Knox, Ryan P., Aaron S. Kesselheim, and Ameet Sarpatwari, 2022

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

Harvard-MIT CRS Open House

September 27, 2022 12:00 – 1:30pm ET
Waterhouse Conference Room, Harvard Medical School

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Twitter @Harvardmit_CRS

Harvard-MIT Center for Regulatory ScienceFollow

Center within @HiTSatHarvard @HarvardMed • Drug development, translational science & @US_FDA #FDAInformed

Harvard-MIT Center for Regulatory Science @HarvardMIT_CRS·

21 Sep

Stop by our open house next week to learn about research and opportunities at CRS. Refreshments will be served! Help us plan by RSVPing here: https://bit.ly/3eEtjIF

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Harvard-MIT Center for Regulatory Science @HarvardMIT_CRS·

15 Sep

Please join us in welcoming our newest postdoctoral fellow, Trupti Shetty, PhD. We're so pleased to have her join the CRS team!

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Harvard-MIT Center for Regulatory Science @HarvardMIT_CRS·

13 Sep

Thank you to those who joined us at today's #RegSci Forum. It was a pleasure to hear @VasumPeiris present "A National Pediatric Medical Device Ecosystem: Bridging the Technology Divide." #Medicaldevices #Pediatrics

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Harvard-MIT Center for Regulatory Science @HarvardMIT_CRS·

31 Aug

Register today for the first #RegSci forum of the academic year. @VasumPeiris, Chief Medical Officer and Director for Pediatrics and Special Populations at the FDA CDRH, will join us. Don't miss it! 🔗https://bit.ly/3Q5Ka43

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