DIA 2013 49th Annual Meeting
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Legal Jeopardy from the Conduct of Clinical Trials
Track : Track 10: Public Policy/ Health Care Compliance/ Law
Program Code: 136
Date: Monday, June 24, 2013
Time: 2:30 PM to 4:00 PM  EST
Location: 153AB
CHAIR :
 Mark C. Hegarty, Esq, JD (SCHNON), Partner/Attorney, Shook, Hardy & Bacon L.L.P., United States
SPEAKER (S):
 John M. Isidor, JD (SPKNON), CEO, Human Subject Protection Consulting, LLC, United States
 Jeffrey N. Gibbs, JD (SPKNON), Director, Hyman Phelps & McNamara, PC, United States
David Forster, JD,MA (SPKNON), Vice President, Office of Compliance, Western Institutional Review Board, United States
 Marc B. Wilenzick, Esq, JD (SPKNON), Consultant, Core Risks, Ltd, United States
Kate Gallin Heffernan, FFPM (SPKNON), Verrill Dana LLP, 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. The audience will also participate in the game show format.