As personalized medicine and targeted drug 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 to apply toward the use of 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)

This workshop is sponsored by the The North Carolina Translational Sciences Institute (NC TraCS) in collaboration with Research Triangle Institute (RTI)