DIA 48th Annual Meeting
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How Industry Can Partner with FDA in Defining a Risk-based Monitoring Program
Track
:
Track 01: Clinical Operations
Program Code:
301
Date:
Wednesday, June 27, 2012
Time:
8:00 AM to 9:30 AM
EST
CHAIR
:
Jan Pierre, Dynport Vaccine Company LLC CSC, United States
PRESENTER
(S):
Charles Preston, Beardsworth Consulting Group Inc
Terry Winchell, GCP Innovative Dynamics, LLC, United States Jan Pierre, Dynport Vaccine Company LLC CSC, United States
Description
FDA encourages more effective monitoring of clinical trials through their August 2011 draft guidance. Risk-based monitoring strategies and approaches will be discussed from the FDA, sponsor and site perspectives, and a focus on expected key changes in FDA's bioresearch monitoring (BIMO) inspection program will be provided.
Learning Objectives:
Identify infrastructure, ethical, scientific, and practical risks in running quality clinical trials
Discuss suitable controls to monitor and mitigate inherent risks
Describe elements of a risk monitoring checklist to be incorporated in an effective clinical monitoring plan.
Learning Objectives:
Identify infrastructure, ethical, scientific, and practical risks in running quality clinical trials
Discuss suitable controls to monitor and mitigate inherent risks
Describe elements of a risk monitoring checklist to be incorporated in an effective clinical monitoring plan.
This session is a part of:
Handout Online
