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Legal Jeopardy from the Conduct of Clinical Trials
Session Chair(s)
Mark C. Hegarty, JD
Partner/Attorney
Shook, Hardy & Bacon L.L.P., United States
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 : 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.
Speaker(s)
Panelist
John M. Isidor, JD
Human Subject Protection Consulting, LLC, United States
Chief Executive Officer
Panelist
Jeffrey N. Gibbs, JD
Hyman Phelps & McNamara, PC, United States
Director
Contestant
Kate Gallin Heffernan, FFPM
Verrill Dana LLP, United States
Counsel
Contestant
David Forster, JD, MA
WCG, United States
Chief Compliance Officer
Contestant
Marc B. Wilenzick, JD
ViS Research Institute, United States
Head, Stakeholder Engagement
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