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
Speaker:
Leslie Sam, BA, CSSBB, CQIA, President, Leslie Sam and Associates, LLC