Programs & Centers

6th Annual Health Law Regulatory & Compliance Competition


Sponsored by the Law & Health Care Program and the Student Health Law Organization

Saturday, March 4, 2017

Competition Supporters

AHLA
Arnold & Porter
EpsteinBeckerGreen
FDLI
HPM
McDermott
Nelson Mullins
Ober Kaler

The Health Law Regulatory & Compliance Competition is a unique and innovative competition that challenges students to navigate through the complex regulatory landscape of health care law, including compliance with health care regulations and FDA law.

Call to Compete:

We would like to invite you to participate in the 6th Annual Health Law Regulatory & Compliance Competition, which is being held on Saturday, March 4, 2017, from approximately 8:00 a.m. until 3:00 p.m. at the University of Maryland Francis King Carey School of Law in Baltimore, MD. There is no cost to enter the competition, however, teams must cover expenses associated with travel and lodging. Breakfast and lunch, along with light refreshments will be served the day of the competition.

Instructions for Registering:

Download the Intent to Compete Form, which is due by 5 p.m. on Friday, December 16 at 5:00 p.m..  Please email forms to Eli Sherlock (2L) at MarylandCareyHealthCompetition@gmail.com.

About the Competition:

The Competition requires teams of 2-3 students to analyze a hypothetical fact pattern involving various interactions between health care stakeholders and entities participating in several health care activities that necessitate regulatory and compliance oversight. The fact pattern will be given to teams the day of the completion, and students will have approximately 1.5 hours to analyze the problem. Teams will then present their findings and recommendations to a panel of practicing regulatory and compliance attorneys. The winner will be announced at the Competition during the celebratory competition luncheon.

The 6th Annual Competition will focus on interactions and arrangements between various healthcare stakeholders, including healthcare institutions, healthcare professionals, drug and device manufacturers, and related third parties. Specifically, this year's problem will challenge students to address several areas, including but not limited to:

  • FDA life-cycle management, including but not limited to pre-clinical research, clinical trials, and FDA approval pathways and marketing applications;
  • Bioethical research issues, access to investigational products, and human research protection issues for drugs, medical devices, and/or biologics;
  • FDA post-marketing requirements, including but not limited to labeling, advertising, promotion, manufacturing, drug compounding, and supply chain security and distribution; and
  • Healthcare fraud & abuse and compliance issues, including the Anti-Kickback Statute and applicable safe harbors and exceptions, the False Claims Act and applicable qui tam provisions, and exclusion by HHS-OIG.

If you would like more information about the Competition or have any additional questions, please email student coordinator Eli Sherlock or Virginia Rowthorn, Managing Director, Law & Health Care Program


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500 W. Baltimore Street, Baltimore, MD 21201-1786 PHONE: (410) 706-7214 FAX: (410) 706-4045 / TDD: (410) 706-7714

Admissions: PHONE: (410) 706-3492 FAX: (410) 706-1793

Copyright © 2016, University of Maryland Francis King Carey School of Law. All Rights Reserved