As the ICH E6(R3) guideline reshapes expectations for Good Clinical Practice, organizations must go beyond compliance to embed risk-based thinking and critical-to-quality practices across functions. This panel brings together senior leaders to share firsthand experiences of putting the new guideline into practice—from big-picture strategy to everyday decision-making. Panelists will discuss how critical thinking supports better choices, where risk-based approaches add the most value, and lessons learned in leading the cultural mindset shift needed for sustainable quality practices. Attendees will walk away with practical strategies to lead change, collaborate across functions, and build systems that last.

CEU: 1.00 ACRP

Speakers:

• Lisa Ince, BS, CCRC, CCRA, FACRP, Project Manager, Syneos Health

• Katherine Mary Marangio, MSc, Learning Program Consultant, Parexel Academy

• Emma Pinto, BA, MBA Candidate, Manager, Clinical Trial Professional Development, Kaiser Permanente Northern California Clinical Trials Program

• Leslie Sam, BA, CSSBB, CQIA, President, Leslie Sam and Associates, LLC

• Jennifer Tugwell, MSN, RN, ACRP-CP, Sr. Manager Clinical Trials Education, Training & Policies, City of Hope