Pharmacovigilance Interview Questions: What are aggregate reports?| Q22

What are aggregate reports? Question - 22 Pharmacovigilance Interview Questions by Ramya. Watch all Interview Questions https://bit.ly/3iWqGRV . To know more details visit https://www.greatonlinetraining.com
Question - 22: What are aggregate reports?
Aggregate reporting is the process that reviews the cumulative safety information from a wide range of sources, on a periodic basis and
submits the findings to regulators worldwide.
These reports focus not so much on individual cases, but rather on overview, assessment of the safety profile and
benefit-risk-evaluation of Adverse Drug Reaction (ADR) and the Serious Adverse Event (SAE) and pregnancy reports.
Though the Individual case safety reports were submitted on an expedited basis to regulatory authorities, detailed analysis and evaluation
of the benefit/risk ratio of a drug are not possible at this level. Therefore periodically reviewing safety reports received cumulatively
worldwide, becomes highly significant to analyze the benefit/risk balance of the product.
Types of aggregate reports:

Pre-marketing report:
IND annual reports and Annual Safety Reports (ASR) in Europe.
Clinical study reports (CSR).
Development Safety Update Report (DSUR).
These IND and ASR reports were replaced by a well-harmonized document, a development safety update report (DSUR).

Post-marketing report:
Periodic Benefit-Risk Evaluation Report (PBRER)/Periodic Safety Update. Report (PSUR).
Periodic Adverse Drug Experience Report (PADER).
NDA and ANDA annual reports.