Humanitarian Use Devices Made Simple

Thursday, May 25
Presentation: 2:00-3:00pm ET
Q&A: 3:00-3:15pm ET

Humanitarian use devices (HUDs) represent a unique class of medical device, with special requirements that can sometimes prove challenging to researchers, clinicians and IRB members.

In this presentation, Robert Romanchuk, Vice Chair at Schulman IRB, seeks to simplify the HUD topic, drawing on his experience managing HUD use as a research administrator in a large community health system and reviewing HUDs as an IRB Chair. In this presentation, he will distinguish humanitarian devices from investigational devices and drugs and identify key issues and best practices in the review and use of HUDs.

Presentation Objectives
In this free webinar, we will:

  • Outline the background, purposes and nuances of HUD regulation, review and use.
  • Illustrate the fundamental differences in regulations governing the use of HUD and those governing investigational products.
  • Identify and develop ways to effectively manage the institutional challenges in the use of HUDs.
Who Should Attend
  • Clinical research coordinators and managers
  • IRB managers and members
  • Clinical trial billing professionals
  • Institutional Officials
Certificates of attendance are available for this event. This presentation may qualify for continuing education credits; check with your certifying organization(s) for more information.


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