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Monday, June 28 • 2:30pm - 3:30pm
#135 SL: Risk-Based Remote Site Monitoring

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Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-542-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.

Chair

Patricia Santos-Serrao, RAC

Speaker

Technology in Risk-Based Remote Monitoring and Oversight
Patricia Santos-Serrao, RAC

Overcome Site Regulatory (ISF) Issues Part 1
Richard Arlow, MS

Overcome Site Regulatory (ISF) Issues Part 2
Len Rosenberg, PhD, RPh


Speakers
avatar for Patricia Santos-Serrao

Patricia Santos-Serrao

Director of Product Management, Pharmaceuticals and Biologics, MasterControl, United States
Patricia entered the Life Sciences Industry in 1994 starting her career at Schering-Plough in Kenilworth, NJ and later joining Boehringer Ingelheim Pharmaceutical in Ridgefield, CT. Within both organizations she took a leading role in transitioning business processes, document management... Read More →
avatar for Richard Arlow

Richard Arlow

Founder and Chief Executive Officer, Complion, United States
Drawing on his engineering background and inspired by his work in clinical medical research as an MD/PhD candidate, Rick Arlow built the first version of the Complion software platform. In close collaboration with leading medical centers, Complion’s industry-leading workflow and... Read More →
avatar for Len Rosenberg

Len Rosenberg

Head of Clinical Operations, Beat AML, a division of The Leukemia and Lymphoma Society, United States
Len Rosenberg is an executive with proven experience in driving operational excellence at all levels within the pharmaceutical, biotechnology, CRO and eClinical sectors - diverse background includes executive management, clinical and regulatory operations, business development and... Read More →

Monday June 28, 2021 2:30pm - 3:30pm EDT
TBD Virtual Event Horsham, PA 19044
  08: RD Quality-Compliance, Session