Legal Jeopardy from the Conduct of Clinical Trials

Track:
Public Policy/ Health Care Compliance/ Law

Day & Time:
June 24, 2:30PM - 4:00PM

Session Number:
136

Room Number:
153AB

Level:
Basic

Type:
Forum

Title:
Legal Jeopardy from the Conduct of Clinical Trials

Chair(s):
Mark C. Hegarty, JD
Partner/Attorney
Shook, Hardy & Bacon L.L.P., 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.

Learning Objective(s):
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.

Presentation(s) & Speaker(s):
Panelist
John M. Isidor, JD
CEO
Human Subject Protection Consulting, LLC, United States

Panelist
Jeffrey N. Gibbs, JD
Director
Hyman Phelps & McNamara, PC, United States

Contestant
Kate Gallin Heffernan
Founder
KGH Advisors LLC , United States

Contestant
David Forster, JD,MA
Vice President, Office of Compliance
Western Institutional Review Board, United States

Contestant
Marc B. Wilenzick, JD
Consultant
Core Risks, Ltd, United States