CHAIR
:
SPEAKER
(S):
John M. Isidor,
JD (SPKNON), CEO,
Human Subject Protection Consulting, LLC, 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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Jeffrey N. Gibbs,
JD (SPKNON), Director,
Hyman Phelps & McNamara, PC, United States
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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David Forster, JD,MA (SPKNON), Vice President, Office of Compliance, Western Institutional Review Board, United States
Marc Wilenzick is an FDA regulatory and compliance lawyer. He is the Head of Stakeholder Engagement at the ViS Research Institute, a consultant with Core Risks Ltd., and a member of the Board of Directors of AAHRPP. Previously, he was an Assistant GC and Deputy Compliance Officer at Pfizer
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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.