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Wednesday, June 22 • 11:15am - 12:15pm
#327: New Approaches to Inspections

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-615-L04-P ; CME 1.00; RN 1.00

The oversight of GxP activities during the COVID-19 pandemic was limited to mission critical activities. This session will discuss about approaches adapted by international regulatory authorities to ensure regulatory oversight of GxP activities during the COVID-19 pandemic. It also discusses about approaches to increase health authorities confidence in the quality and compliance of clinical trials data.

Learning Objectives

Apply ICMRA’s global regulator perspective on the change from on-site inspections during the pandemic to remote ways of maintaining regulatory oversight (and potential influence on industry practices) and what the future may look like for inspections; Describe innovative alternative methods adopted by the US FDA to evaluate data integrity and reliability during the COVID-19 pandemic; Discuss tools to increase health authorities confidence in the quality and compliance of clinical trials data.

Chair

Kassa Ayalew, MD, MPH

Speaker

Using a Quality Briefing Document increases Health Authorities Confidence in the Quality and Compliance of Data Submitted
Cynthia Eckstein

A Global Regulator Perspective: Remote Inspection Reflections
Paula Walker, MA

FDA’s Innovative Alternative Approaches to On-Site Good Clinical Practice (GCP) Inspections During COVID-19 Pandemic
Jenn Sellers, MD, PhD



Speakers
avatar for Kassa Ayalew

Kassa Ayalew

Director, DCCE, OSI, Office of Compliance, CDER, FDA, United States
Kassa Ayalew, M.D., M.P.H. is a Director of the Division Clinical Compliance Evaluation in the Office of Scientific Investigation at Center for Drug Evaluation and Research (CDER) in FDA. He is a practicing pediatric infectious disease specialist with over several years of clinical... Read More →
avatar for Cynthia Eckstein

Cynthia Eckstein

Senior Principal Quality Lead, Genentech, A Member of the Roche Group, United States
Cynthia Eckstein spent several years as a lab rat starting in GMP doing QC product release of radiopharmaceutical diagnostics before moving to the EPA GLP realm where she conducted trace residue pesticide analysis. When the opportunity arose, she jumped at the chance to be the auditor... Read More →
avatar for Jenn Sellers

Jenn Sellers

Senior Medical Officer, FDA, United States
Dr. Sellers is a board certified pediatrician working as a senior medical officer at Good Clinical Practice Assessment Branch in the Office of Scientific Investigation at Center for Drug Evaluation and Research (CDER) in FDA. She has clinical experience for over 20 years. She also... Read More →
avatar for Paula Walker

Paula Walker

Head of Compliance (GCP, GPvP, GLP & GxP Expert Circle), Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Paula Walker has been with the MHRA since 2009, joining as a GCP inspector, and subsequently moving to the role of Operations Manager for the GCP team in 2013. Paula is currently the Head of Compliance (1) responsible for the GCP, GPvP, GLP inspections teams and GxP Expert Circle... Read More →


Wednesday June 22, 2022 11:15am - 12:15pm CDT
Room 185 AB McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  08: RD Quality-Compliance, Session