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Many regulatory agencies require companies to submit aggregate safety reports periodically for their products. Examples of aggregate safety reports include periodic safety update reports (PSURs), periodic benefit-risk evaluation reports (PBRER), Addendum to Clinical Overview (AdCO), Voluntary Malfunction Summary Report (VMSR), Cosmetic Product Safety Report (CPSR), developmental safety update report (DSUR), IND-Annual Report, etc. Many misconceptions […]
In the past, Inspections/ audits were synonymous with ‘travel’- both domestic and International, but it is not the norm these days. In 2020, when the Covid-19 crisis plagued the Pharmaceutical industry, many companies had to compromise on their annual audit plans and schedules. With the BCP measures in place, many companies were able to realize […]