Training Augmented Intelligent Capabilities for Pharmacovigilance: Applying Deep-learning Approaches to Individual Case Safety Report Processing

Introduction Regulations are increasing the scope of activities that fall under the remit of drug safety. Currently, individual case safety report (ICSR) collection and collation is done manually, requiring pharmacovigilance professionals to perform many transactional activities before data are available for assessment and aggregated analyses. For a biopharmaceutical company to meet its responsibilities to patients and regulatory bodies regarding the safe use and distribution of its products, improved business processes must be implemented to drive the industry forward in the best interest of patients globally. Augmented intelligent capabilities have already demonstrated success in capturing adverse events from diverse data sources. It has potential to provide a scalable solution for handling the ever-increasing ICSR volumes experienced within the industry by supporting pharmacovigilance professionals’ decision-making.