NRP Education Session: Understanding When Assays Become Investigational Devices

Join the NRP for their latest education session. Cassie Myers, CIP and Mike Matamoros, MS, CIP from the UNC Office of Human Research Ethics (OHRE) will help attendees better understand the relationship between assays and investigational devices.

Presentation Topics Includes:

• Understand the different stages of assay development and apply the applicable regulatory framework, specifically investigational devices regulations
• Accurately complete the IRBIS application, Assay tables, and consent forms to facilitate IRB review processes
• Evaluate when a modification occurs how this will impact the regulatory framework and IRB requirements

Attendance at this event is pending approval for 1 contact hour of clinical research education on applications for Maintenance of ACRP’s CCRC®, CCRA®, CPI® or ACRP-CP® certification designations

Presenters

Cassie Myers, CIP, Director
UNC OHRE

Mike Matamoros, MS, CIP, IRB Quality Improvement/Assurance Manager
UNC OHRE

Register