Name
What You Need to Know About New FDA Regulations on Research Participant Protections
Date & Time
Monday, May 22, 2023, 10:45 AM - 12:15 PM
Location Name
Congress B-C (4th Fl)
Description
In September 2022, FDA released a Notice of Proposed Rule-Making (NPRM), which is an advance draft of planned revisions to regulations around IRBs and requirements for the protection of research participants, including requirements for informed consent.
In this session moderated by David Borasky (VP of IRB Compliance at WCG IRB), experts will discuss the history of these proposed changes, what they mean for researchers and research sponsors, what you need to be doing to prepare for compliance, and anticipated regulatory timelines.
Speakers
Dave Borasky - Vice President, Review Solutions - WCG
Linda Coleman - Director, Human Research Protection Program - Yale University
Karen Giardiello - Supervisory Regulatory Counsel - Office of Clinical Policy, Office of Clinical Policy & Programs, Food & Drug Administration
Linda Coleman - Director, Human Research Protection Program - Yale University
Karen Giardiello - Supervisory Regulatory Counsel - Office of Clinical Policy, Office of Clinical Policy & Programs, Food & Drug Administration
