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Legal Jeopardy from the Conduct of Clinical Trials
Program Code:
165
Date:
Monday, June 25, 2012
Time:
3:30 PM to 5:00 PM
EST
CHAIR
(S):
As a partner with Shook, Hardy & Bacon L.L.P., Mr. Hegarty specializes in the defense of manufacturers of drugs and medical devices on a national basis. Mr. Hegarty has experience in numerous segments of the industry, including medical, legal, regulatory, marketing, and professional communications.
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Gary Yingling is a partner with K&L Gates. His practice focuses on regulatory and legal issues concerning food, drugs, medical devices and cosmetics. He works primarily with FDA, but also represents clients before the USDA Food Safety & Inspection Service, EPA, CPSC, the FTC, and various states.
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PRESENTER
(S):
Gary Yingling is a partner with K&L Gates. His practice focuses on regulatory and legal issues concerning food, drugs, medical devices and cosmetics. He works primarily with FDA, but also represents clients before the USDA Food Safety & Inspection Service, EPA, CPSC, the FTC, and various states.
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David Vulcano, Hospital Corporation of America
Mr. Gibbs has represented health care companies on FDA-related matters since 1984. He advises companies on a wide variety of issues, including product approvals, marketing, clinical studies, and enforcement.
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Kate Mazan, The Clinical Technology, United States
John Isidor,
Schulman Associates IRB, Inc., United States
Previously, he served as a litigation attorney, specializing in civil and criminal law. Since becoming involved in clinical research, Mr. Isidor has become a frequent lecturer on how legal and regulatory issues affect the conduct of clinical trials.
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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.