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Part of the Wright Center CReSS Workshop series, this workshop focuses upon Investigational New Drugs & Devices. After completing this workshop, the learner will be able to: 1. define the FDA`s involvement with IND and IDE applications. 2. identify the similarities and differences in the roles and responsibilities of an IND/IDE Sponsor, Investigator, and Sponsor-Investigator. 3. know what resources are available for those participating in faculty held IND/IDE studies at VCU.

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plate with fork and knife, books, microscope and test tubes

Sponsor(s): Office of Research and Innovation: Wright Center
Speaker(s): Elizabeth Collins, MA, CCRP; FDA Regulatory Program Manager, OVPRI & Translational Workforce Development Working Group
Audience: VCU Faculty, VCU Staff

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Clinical Research Skills Series-Understanding the FDA Framework for the World of Investigational New Drugs and Devices