DIA 48th Annual Meeting
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Legal Jeopardy from the Conduct of Clinical Trials
Track : Track 10: Public Policy/Health Care Compliance/Regulatory Law
Program Code: 165
Date: Monday, June 25, 2012
Time: 3:30 PM to 5:00 PM  EST
CHAIR (S):
 Mark Hegarty, Shook, Hardy & Bacon L.L.P., United States
 Gary Yingling, K&L Gates
PRESENTER (S):
 Gary Yingling, K&L Gates
David Vulcano, Hospital Corporation of America
 Jeffrey Gibbs, Hyman Phelps & McNamara, United States
Kate Mazan, The Clinical Technology, United States
 John Isidor, Schulman Associates IRB, Inc., United States
Description
This forum will address a wide range of regulatory and legal issues governing modern clinical research. Using a well known game show format, experts will compete to show their knowledge of the elements of informed consent, IRB requirements, FDA regulations, the history of clinical investigations, and other key topics.

Learning Objectives:
Identify the civil and criminal liability risks of conducting clinical trials through case studies
Describe the Sponsor's and CRO's exposure to regulatory liability for failure to properly monitor research: Identify what types of clinical trial misconduct could give rise to a criminal prosecution: Discuss recent trends as to liability.