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Center of Excellence in Regulatory Science and Innovation

Center of Excellence in Regulatory Science and Innovation

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In our rapidly evolving scientific landscape, the complexity of the Food and Drug Administration’s primary charge – to safeguard the health and well-being of the public through the application of scientifically sound regulatory activities – is constantly being challenged.

The CERSI program was created to provide institutions with a valued opportunity to work directly with regulators while simultaneously providing the FDA opportunities for access and exposure to advanced scientific exchange and training focused on the FDA’s priority areas.  As one of the world’s leading institutions in higher education, Johns Hopkins University is pleased to collaborate with the FDA in the development of fundamental new knowledge and tools to advance regulatory science.
 

2017 WRITING COMPETITION 

We are pleased to announce the winners of the 2017 CERSI Writing Competition! 

First place: Dana Wiegand, "Clinical Development Strategies and Regulatory Outcomes of FDA Approved Biological License Applications- Therapeutic Domain Considerations"

Second place: Adria Tyndall, "Human Factors Studies in Biologic License Applications for Injectable Device-Biologic Combination Products"

Third place: Carrie Voycheck, "The Relationship Between Medical Device Recalls and the Volume of Medical Device Reports (MDRs) Submitted to FDA"


Each year, we invite students to submit a manuscript on a regulatory science or food safety regulation topic of their choice. The call for submissions for the next competition will disseminated in early 2018.

Winners will receive a cash prize for first, second, and third place, respectively.

Participants must be enrolled in the Masters of Science in Regulatory Science or Masters of Science in Food Safety Regulation at Johns Hopkins University. For more information, please see the Official 2017 Writing Competition Guidelines.

Click here to view our winners from previous years.

 

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To receive updates on events, seminars, workshops and more, press the button below or email cersi@jhu.edu to be added to the listserv.

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Research

Strategically focused efforts pertaining to regulatory science.

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Training

State-of-the-art tools and methods to support regulatory science.

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Events

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