PRIM&R 2024

Seattle Convention Center (SCC) Summit Building, Seattle, WA

Connect with WCG at Booth #301

We look forward to meeting you at the Public Responsibility in Medicine and Research (PRIM&R) 2024 annual conference. WCG is committed to partnering with the research community and connecting the network of industry regulators, academics, and participants with the capabilities, data, technology, and expertise needed to successfully advance global health.

WCG Live at PRIM&R 2024

Mastering the FDA’s Impending sIRB Mandate: Essential Insights & Institutional Success Stories   

Nov. 18 from 12:45 – 1:30 p.m. PST

Join us for a live presentation and Q&A session on the Food and Drug Administration’s (FDA) impending single Institutional Review Board (sIRB) mandate and its implications for institutions. The expert panel features representatives from three institutions, Baptist Health South Florida, University of Cincinnati, and University of Florida, that have updated their policies to comply with the mandate. They will share their experiences and best practices for preparing for sIRB requirements. Moderated by WCG, this interactive session will provide a unique opportunity to ask questions, share concerns, and learn from peers who have navigated the challenges of sIRB implementation.   

Learning Objectives:  

  1. Understand the key requirements of the FDA’s impending sIRB mandate: Participants will gain a clear understanding of the regulatory requirements and potential timelines associated with the sIRB mandate, as well as the implications for institutions.   
  1. Identify effective strategies for updating institutional policies and procedures to comply with the FDA’s impending sIRB requirements: Participants will learn from the experiences of institutions that have successfully implemented sIRB-compliant policies and procedures and gather practical tips for overcoming common challenges.   
  1. Develop a plan for implementing the FDA’s impending sIRB requirements at their own institution: Participants will be able to develop a plan for implementing sIRB requirements at their own institution, including strategies for updating policies, training staff, and addressing potential challenges.   

Speakers:

David Forster, JD, MA, CIP 
Chief Compliance Officer
WCG  

Christopher Gennai, CIP  
Senior Institutions Partnership Advisor
WCG  

Michael Linke, PhD  
Adjunct Professor, UC College of Medicine 
Chair, StrokeNet Central IRB 
SMART IRB Program Director, Education 

Scott Lipkin, DPM, CIP 
Vice President for Research
Baptist Health South Florida 

Michael Mahoney 
Director, Research Operations and Services
University of Florida