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Monday, June 17 • 2:15pm - 3:15pm
#138: Having the End in Mind When Building Quality into Clinical Trials: A Regulatory and Industry Perspective

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Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-538-L04-P; CME 1.00; RN 1.00

This session will discuss regulatory and industry perspectives on building quality into clinical trials by providing updates to agency policy of risk-based monitoring (RBM), quality risk management (QRM), and quality-by-design (QbD) (e.g., ICH E6R3, ICH E8R1, draft and final guidances), including case examples.

Learning Objectives

Discuss the importance of building quality into clinical trials; Identify a study’s critical quality (CTQ) factors and the importance of involving all stakeholders in their identification; Describe FDA’s expectations for implementing quality-risk management and developing and executing risk-based monitoring plans to focus on CTQ factors with inspection case examples of sponsors, CROs, service providers and clinical investigators.

Chair

Kenneth Getz, MBA

Speaker

Speaker
Linda B Sullivan, MBA

FDA Update
Elena Boley, MD, MBA, FACP

Industry Update
Michael Torok, PhD


Speakers
avatar for Kenneth Getz

Kenneth Getz

Tufts Center for the Study of Drug Development, Center For the Study of Drug Development, United States
Ken Getz is the Executive Director and a Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine. He is also the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical... Read More →
avatar for Elena Boley

Elena Boley

Senior Physician, OSI, OC, CDER, FDA, United States
Dr. Boley is a senior physician in the Good Clinical Practice Assessment Branch of the Division of Clinical Compliance Evaluation (DCCE)/Office of Scientific Investigations (OSI) in CDER/FDA. She provides regulatory and scientific oversight for CDER-assigned bioresearch monitoring... Read More →
avatar for Linda Sullivan

Linda Sullivan

Senior Fellow, Tufts Center For the Study of Drug Development, United States
Ms Sullivan is a Senior Fellow at the Tufts Center for the Study of Drug Development. She has more than 30 years of experience working in the Healthcare and Clinical Research industries helping organizations optimize processes to improve financial and quality outcomes. She founded... Read More →
avatar for Michael Torok

Michael Torok

Vice President, Global Head of Quality Assurance Programs, Genentech, A Member of the Roche Group, United States
Michael Torok, Ph.D. is the Global Head of Quality Assurance Programs at Genentech/Roche. He is energized and driven by the mission of positioning Quality to be an accelerant in developing new therapeutics, rather than a guardrail or "policemen". To enable this shift, cross-functional... Read More →

Monday June 17, 2024 2:15pm - 3:15pm PDT
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  08: RD Quality-Compliance, Session