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Monitoring of literature for aggregated reports and safety information
Based on the marketing authorization status various types of reports are prepared by the MAH, which contain pre-approval aggregate safety reports and post-approval aggregate safety reports. So, Pharmacovigilance aggregate reporting is deemed a large commitment and takes considerable effort. The scientific and medical literature is an important source of data for the safety profile of medicinal products for detecting new safety signals or emerging safety issues (ESI). With Atop Pharma Solution pharmacovigilance literature review, literature critics can first levy references for ICSRs and eradicate those that are irrelevant for safety. With this workflow in place, it directs only 20-30% of the connections to product safety specialists, cutting their literature review time by 80%. As the reviews for aggregate reports and safety signals are 4-5 times pricier than ICSR reviews, the potential savings are enormous.