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Risk-Based Monitoring: From Concept to Practice

Track:
Clinical Operations

Day & Time:
June 17, 10:30AM - 12:00PM (Pacific Standard Time)

Session Number:
227

Room Number:
2

Level:
Intermediate

Type:
Forum

Title:
Risk-Based Monitoring: From Concept to Practice

Chair(s):
Nicholas Alp, MD, PhD, FRCP
Vice President, Drug Development Services
ICON, United Kingdom

Description:
This forum will explore risk-based monitoring, including adapting internal processes and working with third-party providers. Pharmaceutical and CRO experts, with direct experience of working together on these initiatives, will present and lead an interactive discussion.


Learning Objective(s):
Describe the benefits and challenges of implementing risk-based monitoring; Discuss the various approaches to integrate centralized, offsite, and onsite monitoring, including the relative benefits and limitations; Discuss learnings from study selection, through execution, to submission; Describe the impact on the role of the monitor in terms of skills, capabilities, and change management.

Presentation(s) & Speaker(s):
Successful Messaging for Stakeholders and Decision Makers
Thomas R. Provencher
Senior Director, Clinical Trial Support and Compliance
Pfizer Inc, United States

Models, Processes and Sourcing for Risk-Based Monitoring
Nicole Ratliffe Sheetz, PharmD
Advisor, Clinical Development Innovation
Eli Lilly and Company, United States

Driving Change Management in Risk-Based Monitoring
Brett Wilson
Associate Director, Business Operations
Bristol-Myers Squibb Canada, Canada