Reliable availability of quality medicines requires more than following the rules laid down by regulators. Today's complex, global environment demands that all participants in the supply chain adopt a culture of quality, a culture in which every employee understands and embraces their responsibility for delivering quality outcomes that benefit patients. This focus on quality outcomes must exist across the product life cycle, including product and process development, clinical trials, regulatory submissions and commercial manufacturing. The session will define the characteristics of a quality culture across a range of firms and functions, describe how to assess existing culture and achieve the desired state and outline the benefits for patients, regulators and the pharmaceutical industry.