M-CERSI Accepting Regulatory Science Innovation Submissions

M-CERSI Accepting Regulatory Science Innovation Submissions

M-CERSI Accepting Regulatory Science Innovation Submissions


The University of Maryland Center for Excellence in Regulatory Science and Innovation (M-CERSI) is welcoming submissions to the "America's Got Regulatory Science Talent" competition through January 3, 2021. The competition will take place virtually on January 15, 2021.

This annual contest aims to promote student interest in regulatory science — the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products. Participants will develop and present a proposed solution to a current opportunity in regulatory science. There are numerous needs in regulatory science. Students should consult the FDA Center/Office Regulatory Science Research Priority Areas for the CERSI Program

All full-time and part-time students, including undergraduate, professional, and graduate students, at the Baltimore and College Park campuses of the University of Maryland are eligible to participate. A team can include either an individual or any number of students, although each team member has to contribute to the proposed solution or the presentation.

Developing drugs, devices, and biologics is fraught with challenges. There is continued need for new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products. Example proposed solutions might include:

  • An idea for a new toxicology test
  • A better biomarker
  • An approach to improve manufacturing
  • A way to detect counterfeit biologics
  • A test that evaluates a new medical technology
  • A new data signal that detects adverse reactions from a new drug
  • A way for the FDA to better communicate risks of medications (e.g., friendlier product labels, use of social media, use of crowdsourcing, etc.)
  • A test for food contaminants
  • A way to respond to a nuclear agent
  • A way to get patients to use a device safely

Each presentation will be evaluated by a panel of judges from the University of Maryland and FDA for proposed solution and presentation quality. Elements of proposed solution include novelty and potential significance. Short-term feasibility is a plus, but not a requirement. Elements of presentation quality include verbal communication, visual communication, impact of any A/V materials or demonstrations used, and responses provided during the Q&A session.

Last year's first- place competition winner Team Brain Alliance (Adaeze AmaefuleBreanna OwooHannah Kim, and Sydney Yuen) proposed a user-friendly tool which would synthesize multiple tools provided by the FDA, including recalls, premarket approvals, and registering a device. 

Additional information about competition paticipation is available online

 

Related Articles:
Celebrating 14 Participants of 2021 BIOE REU Program
Development of Diagnostic Biomarkers for Determination of TBI
Welcoming Applicants for Student Entrepreneurship Fellowship
M-CERSI Accepting Applications for Workshops, Research Scientists
BIOE Sophomore Awarded NOAA Hollings Scholarship
FDA Awards $10 Million to Support Regulatory Science, Medical Device Initiatives Co-led by Clark School
"America's Got Regulatory Science Talent" Competition Call for Participants
M-CERSI Now Accepting 2023 Regulatory Science Competition Applications
NCC-PDI Now Accepting Pediatric Medical Device Pitches
In Memoriam: John William Fritz (‘17, electrical engineering)

October 29, 2020


Prev   Next

Current Headlines

Positioning our students for engineering, business, and public service success

The Clark School Celebrates Native and Indigenous Voices in Engineering

Long-Time Terp, Professor and Leading Fire Protection Engineer Retires from the University

Two Clark School Engineers Named Associate Fellows of Aeronautics and Astronautics Institute

Advanced Solid Electrolytes Break World Record for Ionic Conductivity

Meet the A. James Clark Scholars Class of ’28

Aerospace Engineering Celebrates 75 Years

Dean's Circle Spotlight: Terps Cement Legacy—and Leadership Example

News Resources

Return to Newsroom

Search News

Archived News

Events Resources

Events Calendar