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Grant Admin News:



National Council of University Research Administrators Proudly Presents
its

2001-2002

Live Satellite Broadcast

January 15, 2002

The broadcast runs from 8:30 a.m. to 12:30 p.m. in Studio A, Media

Services Center, Knight Library University of Oregon .

Compliance Issues for Clinical Trials

Clinical trials are highly regulated and monitored activities. At the
same time, universities and affiliated medical centers are under
tremendous pressure to move quickly in order for sponsors to capitalize
on intellectual property protection, obtain FDA approval, and deliver a
safe and effective product to the public. This broadcast will examine
major compliance issues affecting clinical trials and the partnership
that exists among Federal agencies, drug manufacturers, clinical
research organizations, academic health centers and private research
organizations for maintaining compliance. Viewers will be able to ask
questions of the panel.

Faculty:

Christina K. Hansen, Assistant Vice Chancellor, Office of Research
Administration, University of California-Irvine;

Joseph Sherwin, Director, Office of Regulatory Affairs, University of
Pennsylvania;

Michael A. Carome, Director, Division of Compliance Oversight, Office
for Human Research Protections, DHHS;

Cynthia Dunn, Director, Clinical Research Institute, University of
Rochester;

David Lepay, Senior Advisor for Clinical Science, Director, Office for
Human Research Trials, FDA

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