CHAIR
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PRESENTER
(S):
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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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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Michael Powers, Buchanan Ingersol & Rooney PC, United States
Bette Bayne, Schulman Associates IRB, United States
Adrienne Hernandez, Shook, Hardy & Bacon L.L.P., United States
Description
In this workshop, experienced lawyers will conduct a mock trial involving issues that may arise in clinical trial lawsuits. The mock trial will include opening statements and closing arguments, as well as realistic direct and cross-examination of the primary witnesses in the case, including video evidence. At its conclusion, the lawyers will entertain questions about the mock trial. **Due to workshop format, seating will be limited and will be available on a first come, first served basis. The Pennsylvania Convention Center has stringent regulations on maximum room capacities, and they are strictly enforced. Once all seats are occupied, DIA will be required to close the workshop, and no more participants will be admitted. Interested attendees are encouraged to arrive at workshops early in order to ensure seating. Please note, as a workshop with interactivity, this event will not be recorded.
Learning Objectives:
Demonstrate how errors and omissions in the conduct of clinical trials are portrayed in the context of lawsuits alleging negligence by sponsors and investigators
Identify common errors and mistakes highlighted during lawsuits alleging negligence by sponsors and investigators.