Pharmacovigilance and Risk Management Strategies Conference

The spontaneous reporting system (SRS) has been a key tool for monitoring post-marketing product safety since the thalidomide tragedy in the 1960s. Today, however, we are in the midst of a safety data rEvolution, and pharmacovigilanties have an insatiable appetite for meaningful data from sources beyond the SRS, particularly digital data. So, the data feast is on and not likely to stop, but the practical conversion of bytes to insights must be refined. Further, more work is needed to confirm the enduring value of such data for safety and benefit-risk assessments. This session will explore the current status of FDA’s Sentinel program, Real World Evidence and registry data, and practical aspects of screening incidental safety information from Customer Engagement programs.