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Risk-Based Remote Site Monitoring
Session Chair(s)
Patricia Santos-Serrao, RAC
Director of Product Management, Pharmaceuticals and Biologics
MasterControl, United States
COVID-19 has forced pharmaceutical companies to go remote for many of their processes. Remote site monitoring is best conducted through a risk-based approach that uses digital systems and AI/ML applications to inform decision-making.
Learning Objective : Discuss how to use risk-based assessments to improve effectiveness of remote site monitoring; Identify ways that Artificial Intelligence/Machine Learning can expedite risk-based decision-making; Compare remote monitoring methods and identify ones likely to persist after the COVID-19 pandemic.
Speaker(s)
Technology in Risk-Based Remote Monitoring and Oversight
Patricia Santos-Serrao, RAC
MasterControl, United States
Director of Product Management, Pharmaceuticals and Biologics
Overcome Site Regulatory (ISF) Issues Part 1
Richard Arlow, MS
Complion, United States
Founder and Chief Executive Officer
Overcome Site Regulatory (ISF) Issues Part 2
Len Rosenberg, PHD, RPH
Beat AML, A Division of Blood Cancer United, United States
Head of Clinical Operations