Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations

Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations
Description

The U.S. Food and Drug Administration (FDA) is announcing the following pubic workshop entitled "Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations."  This public workshop is convened by Duke University's Robert J. Margolis, MD, Center for Health Policy and supported by a cooperative agreement with FDA.  The purpose of the public workshop is to capture stakeholder experiences with risk-based approaches to monitoring (RBM) of clinical investigations and gather stakeholder input on opportunities to further the implementation of risk-based approaches to monitoring.
During the public workshop, speakers and participants will cover a range of issues related to implementation of risk-based approaches to monitoring.  Topics for discussion will include, and are not limited to, challenges to implementation of RBM, enablers to support implementation of RBM, and lessons learned from strategies employed to implement RBM.

Docket No.: FDA-2019-N-0001

Date and Location: The public workshop will be held on July 17, 2019 at the Marriott Marquis Washington, DC at 901 Massachusetts Ave., NW, in Washington DC.