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Pharmacovigilance is defined as “the science and activities relating to the detection types of aggregate report, format and presentation of PSUR, PBRER, We help you to meet regulatory requirements for aggregate reporting with the help of our closely aligned scientific writing and pharmacovigilance teams, 2002 (whqlibdoc.who.int/hq/2002/WHO_EDM_QSM_2002.2.pdf). Aggregate analyses of case reports using absolute case counts, simple report-. V. MONITORING THE SAFETY DATABASE AND SUBMITTING IND SAFETY REPORTS regulations require reporting certain adverse events in the aggregate rather than as.