Effective safety signal detection and management incorporates pharmacovigilance, information technology, medical, regulatory, and governance activities. Biopharmaceutical sponsors are expected to identify safety issues via analysis of all information available to them. As the amount of data has grown, so have tools and strategies to manage safety signals. Each data source and analytic strategy has inherent strengths and limitations. An understanding of these factors is a prerequisite for an effective system of signal triage, prioritization, evaluation and decision-making. The course will present signal detection and management in the framework of regulatory compliance as well as risk management and risk communication strategies. Outputs from signal detection systems will be the basis for hands-on exercises and discussion.
Course Level: Advanced