Regulatory Considerations for the Use and Development of In Vitro Diagnostics (IVDs)

Robert J. Russell, President & CEO RJR Consulting, Inc. (Specializing in Life Science Technology Management / Global Regulatory Compliance / Global Business Development)

When Apr 24, 2014 from 09:00 AM to 11:00 AM (US/Eastern / UTC-400)
Where 219 Brinkhous-Bullitt
Attendees
  • academic researchers, scientists, laboratory directors, and students engaged in IVD research and/or development
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REGISTER HERE: tracs.unc.edu/ivd-workshop

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