Advarra, MI
Joshua Fedewa is an expert in human subject research. He has over fifteen years of experience in regulations and guidelines governing human subjects research. As Director of IRBMED at the University of Michigan and Director of the IRB at the University of Texas Southwestern Medical Center, Joshua held direct responsibility for over 20,000 submissions as well as 5,500 active studies. Joshua’s experience also includes oversight over all IRB operations at academic medical centers. He has expertise in human subjects regulations oversight and operations (IRB), as well as HIPAA Privacy regulations, and research compliance investigations. He has been instrumental in managing animal care and biosafety oversight at an academic medical center affiliate. Josh has extensive experience with a variety of electronic IRB submission and review systems and is also skilled in helping institutions obtain and maintain initial AAHRPP accreditation. Josh has served as an AAHRPP site visitor and has helped guide several institutions through initial accreditation as well as through multiple re-accreditation cycles. Josh has proven expertise in leading projects to improve research document translations which resulted in significant decrease in costs, turn-around times, and an increase in translated documents available for non-English speaking participants. Joshua holds a master’s in research administration from Rush University and is a Certified IRB Professional (CIP).
C03 - Postapproval Monitoring (PAM) in a Single IRB (sIRB) World: FDA Edition
Monday, November 18, 2024
3:30 PM – 4:45 PM PT
Sponsored Presentation from Advarra: FDA sIRB Mandate – Deja Vu All Over Again?
Tuesday, November 19, 2024
7:30 AM – 8:15 AM PT
Wednesday, November 20, 2024
10:30 AM – 11:45 AM PT