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Monday, June 17 • 3:30pm - 4:30pm
#152: Innovative Alternative Approaches to Evaluating GCP During the COVID-19 Public Health Emergency and Beyond

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-551-L04-P; CME 1.00; RN 1.00

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 Objectives

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.

Chair

Emily Gebbia, JD

Speaker

FDA Update
Ling Yang, MD, PhD, FAAFP

Beyond the Pandemic, Sustaining Approaches to GCP Compliance
Paula Walker, MA

Health Canada Update
Jennifer Evans


Speakers
avatar for Paula Walker

Paula Walker

Global Head of Risk Based Quality Management, Roche Products Ltd., United Kingdom
Paula is the Global Head of RBQM at Roche, having started with the company with a Quality Policy focus. Formerly Head of Compliance (GCP/PV/GLP) at the MHRA and Acting Head of Inspectorate, having started in 2009 as a GCP Inspector; spending 13.5 years at the Regulator. Paula has... Read More →
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Jennifer Evans

Compliance Specialist, Health Canada, Canada
Jennifer Evans obtained her degree in Biochemistry from the University of Victoria, in British Columbia, Canada. She worked in the pharmaceutical and biotechnology industries in research, clinical and quality roles for 14 years prior to joining Health Canada in 2012 as a regulatory... Read More →
EG

Emily Gebbia

Associate Director for Regulatory Development, OSI, OC, CDER, FDA, United States
Emily Gebbia is the Associate Director of Regulatory Development in the Office of Scientific Investigations (OSI) in CDER’s Office Compliance at the U.S. FDA. Emily provides strategic leadership and subject matter expertise for OSI’s policy efforts, including the development of... Read More →
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Ling Yang

Senior Physician, OSI, OC, CDER, FDA, United States
Ling Yang is a senior physician in the Office of Scientific Investigations in FDA’s Center for Drug Evaluation and Research. She has worked at FDA for over 15 years and has extensive experience in GCP compliance evaluation, clinical review and FDA regulation of new drugs, generic... Read More →

Monday June 17, 2024 3:30pm - 4:30pm PDT
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  08: RD Quality-Compliance, Session