Pharmacovigilance and Risk Management Strategies Conference

For several years, an increasing amount of individual case safety data has been noted from multiple sources, particularly in the post marketing setting. In this respect, more data does not necessarily translate into optimized signal detection and evaluation, particularly when originating from certain data sources, notably patient support programmes. Recent published findings have supported concerns that overwhelming safety databases with less informative data from PSPs may not only create false safety signals but also potentially obscure true safety signals. These findings provided an impetuous to the reopening of ICH E2D (R1) which is currently in Step 1. In a parallel initiative, ICH E19 aims to optimize safety data collection in late stage clinical trials, using a selective approach in order to improve the efficiency of these clinical trials, as well as reduce the burden on study participants. ICH E19 was released for consultation in 2019 and is currently being updated based on this feedback. This session will evaluate the status of both ICH guidelines and discuss their anticipated contribution to optimizing safety data collection from both clinical trial and post marketing settings.