Aggregate Reporting

This chapter provides comprehensive information on aggregate reporting (AR) methods employed in the context of literary analysis. It reconnoiters the fundamental concepts, importance, types, and significance followed by the challenges of AR. Since the development of a new drug to post-market surveillance, it is obligatory to track the complete information on a benefit–risk ratio before it reaches the market and a much wider population, AR has been included to look at the safety profile. Aggregate safety reports need to be submitted for products or drugs with marketing approval and should be submitted to governing authorities for a period of the drug that is marketed anywhere over time. The supervisory obligation for submission and AR format varies for different countries. Significant information should be submitted with reliability to governing bodies, i.e., the Food and Drug Administration (FDA), and the European Medicines Agency (EMA) to evade repeating data. The current chapter emphasizes mainly the types of AR, format, and demonstration of development safety update reports (DSUR), periodic adverse drug experience reports (PADER), periodic safety update reports (PSUR), periodic benefit–risk evaluation reports (PBRER), and the significant form of AR to be presented for different regulators.