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Tuesday, June 18 • 3:15pm - 4:15pm
#271: How Will the Increasing use of Real-World Evidence for Regulatory Decision-Making Impact QA Strategies and GCP Inspections?

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-603-L04-P; CME 1.00; RN 1.00

This session will bring regulators and industry quality experts together to explore how quality management systems can be developed to meet the challenges real-world evidence presents to QA activities and regulatory inspection expectations.

Learning Objectives

Evaluate quality challenges associated with the use of real-world evidence as part of regulatory studies; Discuss how to apply proportionate risk-based quality assurance activities which meet regulatory expectations.

Chair

Andrew Gray, PhD

Speaker

FDA Update
L'Oreal Walker

FDA Update
Lee H. Pai-Scherf, MD

Industry Perspective
Abi Seifert, MBA


Speakers
avatar for Andrew Gray

Andrew Gray

Director, QA Clinical Therapeutic Area Head, Johnson & Johnson, United Kingdom
Andrew is a member of Johnson and Johnson's R&D Quality organisation where he has responsibility for risk based audit strategy across clinical therapeutic areas. Prior to joining J&J Andrew was a Deputy Director and Head of the Medicines Inspectorate at MHRA. Andrew has led international... Read More →
avatar for Lee Pai-Scherf

Lee Pai-Scherf

Senior Physician, GCP Assessment Branch, DCCE, OSI, OC, CDER, FDA, United States
Lee H. Pai-Scherf, MD, Senior Physician, OSI, Office of Compliance, CDER, FDA Dr. Pai-Scherf is a Senior Physician in the Good Clinical Practice Assessment Branch of the Division of Clinical Compliance Evaluation /Office of Scientific Investigations in CDER/FDA. She provides regulatory... Read More →
avatar for Abi Seifert

Abi Seifert

Global Head Country Development Quality, Novartis , United States
Abi has worked in the Pharma industry for over 25 years, serving in clinical development in both QA and operational roles. Her career started in clinical study monitoring and GCP auditing and evolved into roles that defined strategy around project management, process excellence and... Read More →
LW

L'Oreal Walker

Supervisory Consumer Safety, OBIMO, ORA, FDA, United States
L'Oreal Walker is a seasoned professional with over two decades of experience in regulatory compliance and oversight. Currently serving as a Supervisory Investigator in the Office of Bioresearch Monitoring West Division within the Office of Regulatory Affairs at the FDA, L'Oreal leads... Read More →

Tuesday June 18, 2024 3:15pm - 4:15pm PDT
Room 16AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  08: RD Quality-Compliance, Session