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DIA 2021 Global Annual Meeting


Risk-Based Remote Site Monitoring

Session Chair(s)

Patricia  Santos-Serrao, RAC

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)

Patricia  Santos-Serrao, RAC

Technology in Risk-Based Remote Monitoring and Oversight

Patricia Santos-Serrao, RAC

  • Director of Product Management, Pharmaceuticals and Biologics
  • MasterControl, United States
Richard  Arlow, MS

Overcome Site Regulatory (ISF) Issues Part 1

Richard Arlow, MS

  • Founder and Chief Executive Officer
  • Complion, United States
Len  Rosenberg, PhD, RPh

Overcome Site Regulatory (ISF) Issues Part 2

Len Rosenberg, PhD, RPh

  • Head of Clinical Operations
  • Beat AML, a division of The Leukemia and Lymphoma Society, United States