Assessing safety and to ensure benefits outweigh risks is essential during clinical development of medicines and vaccines. Once approved and products are used more widely, healthcare provision can evolve as can the safety profile. Timely identification and monitoring of safety outcomes across multiple different types of healthcare data from around the world are crucial elements of product lifecycle management. The volume and heterogeneity of data means that quantitative approaches, including machine learning, play a critical role in sensitive, trusted, highly regulated systems to ensure patient safety. This session will describe current advanced analytics and barriers and opportunities for advances.