"America's Got Regulatory Science Talent" Competition Call for Participants

Students at the University of Maryland and University of Maryland, Baltimore are invited to participate in an annual competition 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.

Hosted by the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), the competition showcases student teams who present a proposed solution to a current regulatory science challenge or opportunity.

The 2017 competition will be held at Pharmacy Hall on the University of Maryland, Baltimore campus on Friday, January 27, from 2:15 p.m. - 3:45 p.m. Prizes will be awarded to the top teams, and lunch will be provided for all participants.

Students can enter the competition individually or as a team made up of any number of students (each team member must contribute to the proposed solution/presentation).

Presentation criteria:

The presentation must be 5 minutes in length or less.

The presentation may utilize A/V materials, but it is not a requirement.

Presentations should aim to have high regulatory impact.

Presenters will participate in 2 minutes of Q&A following their presentation.

Those interested in competing should email a completed Information Sheet (.docx) to RegSciTalent@rx.umaryland.edu by January 20, 2017.

Criteria:

Eligibility: All full-time and part-time UMD/UMB students (e.g. undergraduate, professional, graduate) are eligble

Presentation evaluation: Each presentation will be evaluated by a panel of judges from Maryland, as well as from the Food and Drug Administration (FDA) on the basis of proposed solution and presentation quality. Elements of the proposed solution include novelty and potential significance. Short-tfeasbility is a plus, but not a requirement. Elements of presentation quality include verbal communication, visual communication, impact of any A/V materials or demonstrations, and Q&A responses.

Dates, Deadlines, and Parking Info:

By January 20, interested competitors should email RegSciTalent@rx.umaryland.edu with a completed Information Sheet (.docx) for M-CERSI's "America's Got Regulatory Science Talent" Competition.

The competition will be held on Friday, Jan. 27, 2017, from 2:15 p.m. - 3:45 p.m. at Pharmacy Hall, 20 Pine Street, Baltimore, Md., 21201.

Parking information is available at http://www.umaryland.edu/parking/garages/. Participants and attendees should consider either the Saratoga garage or the Penn garage.

Example Proposed Solutions:

Developing drugs, devices, and biologics is fraught with challenges, and 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 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 FDA to better communicate risks of medications (e.g. friendlier product labels, use of social media or YouTube); use of crowdsourcing; a test for food contaminants; a way to respond to a nuclear agent; and how to get patients to use a device safely.

More information about past participants - including the winners of the 2016 competition - is available online.

About M-CERSI

M-CERSI is an FDA-sponsored center at the College Park and Baltimore campuses of the University of Maryland. The mission of the Center is to foster the development of regulatory science - the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products.

Published November 29, 2016