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Implementing Risk-Based Monitoring: Best Practices from Pharmaceutical Industries to Contract Research Organizations
Session Chair(s)
Warren H. Pence
Associate Director, Adaptive and Intelligent Monitoring
PPD, Inc, United States
This session will provide attendees with practical and useful “take-home” information and best practices that can be used by their organizations in the development and implementation of a risk-based monitoring (RBM) strategy.
Learning Objective : Describe management of study risk at a holistic level including management of study risk through ongoing site quality assessments; Incorporate remote monitoring methods using best practices in a risk-based monitoring (RBM) strategy, taking challenges into account; Apply best practices and tools to aid sponsor-contract research organization collaborations in implementation of RBM.
Speaker(s)
Implementation of Off-Site Monitoring: Successes and Challenges
Mary Arnould, BSN, MSN
Astellas, United States
Director, Clinical Science Operations
Elements of Successful Partnering to Execute RBM: A Biopharmaceutical Company Perspective
Peggy Zavala, MHA
Celgene Corporation, United States
Associate Director, Clinical Monitoring-Americas
Managing Study Risk Through Site Health/Quality
Warren H. Pence
PPD, Inc, United States
Associate Director, Adaptive and Intelligent Monitoring
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Ways to register
Registration override should work.