The regulatory landscape of clinical research is about to undergo a seismic shift! Join us for a provocative, must-attend session that unpacks the groundbreaking changes in ICH-GCP E6 (R3) allowing non-physician healthcare professionals to make trial-related medical decisions. This isn't just another regulatory update—it's a strategic deep dive into the future of clinical trial operations.  What exactly does "appropriately qualified healthcare personnel" mean in practice? Who holds the ultimate decision-making power for trial procedure delegation?  How can Principal Investigators maintain comprehensive trial supervision and work effectively with advanced practice providers in the new environment?

Join site and pharma personnel as we challenge assumptions, explore uncharted territory, and equip clinical research sites with insights needed to transform this regulatory change from a potential compliance headache into a powerful opportunity for operational innovation.

Learning Objectives:

1. Analyze the specific regulatory modifications in ICH-GCP E6 (R3) regarding medical decision-making delegation, including an examination of the expanded definition of qualified personnel beyond traditional physician roles.
2. Evaluate the organizational, regulatory and legal considerations surrounding protocol procedure delegation to advanced practice providers, with a focus on developing robust frameworks for decision-making and oversight.
3. Develop strategic approaches for maintaining rigorous scientific integrity and regulatory compliance while effectively implementing expanded delegation within clinical research sites.