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Building Upon Quality by Design and Risk-Based Monitoring Implementation Momentum
Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD
Component Type: Session
Level: Intermediate

This forum will focus on practical Quality by design (QbD) and risk-based monitoring (RBM) clinical trial implementation strategies based on new case study examples of overcoming persistent adoption challenges, fostering organizational change management, and demonstrating value of implementation.

Learning Objectives

Apply practical QbD-RBM implementation strategies based on case study examples not previously publicly presented; Discuss new initiatives under development that will serve as additional future QbD tools; Identify persistent obstacles to broader QbD and RBM implementation, address their negative impacts, and provide applicable solutions to enable future adoption.

Chair

Gerrit Hamre, MA

Speaker

Existing Adoption Tools for All to Use
Morgan Hanger, MPA

Evidence of the QbD-RBM Continuum in Action
Marion Wolfs, MS

New Case Study Examples for Others to Build Upon
Sameera Ibrahim


Speakers
avatar for Gerrit Hamre

Gerrit Hamre

Research Director, Duke-Margolis Institute For Health Policy (DMI), United States
Gerrit Hamre, MA, is a Research Director in Biomedical Regulatory Policy at the Duke Margolis Institute for Health Policy Institute. Gerrit has worked for nearly 20 years in the pharmaceutical industry with a focus on clinical research, regulatory, and commercial roles. Central to... Read More →
avatar for Morgan Hanger

Morgan Hanger

Executive Director, Clinical Trials Transformation Initiative (CTTI), United States
At the Clinical Trials Transformation Initiative (CTTI), Ms. Hanger leads strategic planning and new initiatives. Previously, she was vice president of the online patient research network PatientsLikeMe, where she oversaw programs utilizing patient-generated health data in life sciences... Read More →
SI

Sameera Ibrahim

Head of Risk Governance & Operations, R&D Quality, Bristol Myers Squibb, United Kingdom
MW

Marion Wolfs

Associate Director Risk Management & Central Monitoring, Johnson & Johnson, Netherlands
Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

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