Apr 24, 2014
from 09:00 AM to 11:00 AM
|Where||Brinkhous-Bullitt Room 219|
|Contact Name||Amy Franklin|
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As personalized medicine and targeted therapies move into the research setting, there are new challenges. Regulatory policy must evolve and expand to accommodate this area, as diagnoses and treatment decisions are often being driven by IVDs.
The goal of this workshop is to provide researchers with additional regulatory knowledge, tools and resources that are applicable for research and development of IVDs.
This workshop will address these primary topics:
• How do regulators define “IVD”
• Types of IVDs
• Regulatory compliance considerations in the development of IVDs (U.S.)
• What investigators / clinical trial personnel need to know
• Clinical trial considerations in IVDs
• IVD registration with U.S. FDA
Audience: academic researchers, scientists, laboratory directors, and students engaged in IVD research and/or development
Presenter: Robert J. Russell, President & CEO RJR Consulting, Inc. (Specializing in Life Science Technology Management / Global Regulatory Compliance / Global Business Development)
There is no fee for participation.
Presented by the North Carolina Translational Sciences Institute (NC TraCS) in collaboration with Research Triangle Institute (RTI)