This session will focus on the considerations for global harmonization of quality standards and the definition of the steps required after batch release and prior to administration to the patient (in an opened, closed or hybrid system) at a site close to patient care (POC, e.g., hospital). Representatives from EMA and FDA will be invited to share their perspective and current thinking on the topic. Panelists will present a summary of the BIO survey on current industry practice at POC, points of consideration on quality standards for cell and gene therapy reconstitution steps taking place at POC, including studies to support the quality standards to ensure patient safety, and case studies and innovative approaches at POC to frame the discussion.