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#443: The Quality Blueprint: How Cross-Functional Leadership and Employee Ownership Drive Clinical Trial Excellence
Monday June 15, 2026 2:30pm - 3:30pm EDT
117
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-538-L04-P; CME 1.00; RN 1.00

This forum will present Health Authority (HA) expectations related to a robust Culture of Quality focused on Critical-to-Quality (CtQ) issue management. This session will provide specific examples of how leadership commitment and employee ownership enable a robust Quality Culture.

Learning Objectives

Explain Health Authority (HA) expectations of an effective Culture of Quality, specifically around Critical-to-Quality (CtQ) issue surveillance and management; Describe the vital link, and cultural best practices, between leadership commitment, employee ownership, and the ability to effectively manage CtQ issues.

Chair

Michael Torok, PHD

Speaker

The Quality Blueprint: How Cross-Functional Leadership and Employee Ownership Drive Clinical Trial Excellence
Sameera Ibrahim

The Quality Blueprint: How Cross-Functional Leadership and Employee Ownership Drive Clinical Trial Excellence
Leslie Sam

The Quality Blueprint: How Cross-Functional Leadership and Employee Ownership Drive Clinical Trial Excellence
Emily Gebbia, JD


Speakers
avatar for Emily Gebbia

Emily Gebbia

Associate Director for Regulatory Development, OC, OSI, 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 on good clinical practice, human subject protection, and... Read More →
SI

Sameera Ibrahim

Head of Risk Governance & Operations, R&D Quality, Bristol Myers Squibb, United Kingdom
avatar for Leslie Sam

Leslie Sam

President, Leslie Sam and Associates, LLC, United States
With 30 years of clinical trial research and quality, leadership and six sigma black belt roles, Leslie Sam, President, Leslie Sam and Associates, LLC, collaborates with clients to transform their clinical quality management system design and implementation. She was sought out by... 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., serves as Vice President of Quality Assurance Programs at Roche/Genentech, focusing on de-risking the Development portfolio and accelerating patient access through risk-based quality practices. He leads a global team of Quality Professionals focused on proactive... Read More →
Monday June 15, 2026 2:30pm - 3:30pm EDT
117 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  09: RD-Quality-Compliance, Forum
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Quality Assurance / Control & CMC
  • Tags Forum

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