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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, OC, OSI, 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
Senior Physician, OSI, OC, CDER, FDA, United States
Beyond the Pandemic, Sustaining Approaches to GCP Compliance
Global Head of Risk Based Quality Management, Roche, United Kingdom
Health Canada Update
Compliance and Enforcement Specialist, Health Canada, Canada
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