M-CERSI America's Got Regulatory Science Talent Competition

M-CERSI America's Got Regulatory Science Talent Competition

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M-CERSI America's Got Regulatory Science Talent Competition

Students at the Baltimore and College Park campuses of the University of Maryland are invited to participate in the 2018 "America's Got Regulatory Science Talent" competition.

The competition 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.

The competition requires that each team present a proposed solution to a current opportunity in regulatory science. There are numerous needs in regulatory science, and students are encouraged to consult the scientific priority areas identified in the FDA Strategic Plan for Regulatory Science (August 2011).

The competition will be held at the University of Maryland, Baltimore campus on Friday, February 2, 2018, from 9:30-11 a.m.

Teams may consist of one individual or any number of students. Each team member must contribute to the proposed solution or presentation.

Presentations must be five minutes or less. They may be as simple as a verbal description, or may utilize audio/visual (A/V) materials. Creativity is encouraged, as presentations should aim to have high regulatory impact. Each presentation will be followed by a two-minute Q&A session.

Lunch will be served to competing teams, and prizes will be awarded.

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.

To apply, teams must submit their completed application form (.docx) to RegSciTalent@rx.umaryland.edu by Friday, January 26, 2018.

The competition will be held at Pharmacy Hall on Friday, February 2, 2018, from 9:30-11 a.m. Pharmacy Hall is located at 20 N. Pine Street in Baltimore, MD.

Parking information is available on the campus website. We recommend parking in the Saratoga or Penn garages.

Evaluation:

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.


 

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