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Innovative Alternative Approaches to Evaluating GCP During the COVID-19 Public Health Emergency and Beyond
Session Chair(s)
Emily Gebbia, JD
Associate Director for Regulatory Development, OSI, OC, CDER
FDA, United States
This session discusses regulator and industry experience with the use of alternative tools to evaluate GCP compliance during the COVID-19 public health emergency and post-pandemic.
Learning Objective : Discuss the alternative, innovative, risk-based approaches regulators used to evaluate GCP compliance during the COVID-19 public health emergency; Describe the application of these tools in the post-pandemic environment; Explain industry’s perspective on and experiences with regulators' use of alternative approaches to GCP evaluations.
Speaker(s)
FDA Update
Ling Yang, MD, PhD, FAAFP
FDA, United States
Senior Physician, OSI, OC, CDER
Beyond the Pandemic, Sustaining Approaches to GCP Compliance
Paula Walker, MA
Roche Products Ltd., United Kingdom
Global Head of Risk Based Quality Management
Health Canada Update
Jennifer Evans
Health Canada, Canada
Compliance and Enforcement Specialist
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