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ADVANCED CERTIFICATION TRAINING PROGRAM IN AGGREGATE REPORTING

Aggregate reporting, also known as Periodic Reporting, plays a key role in the safety assessment of drugs. Aggregate reporting involves the compilation of safety data for a drug over a prolonged period of time (months or years), as opposed to single-case reporting which, by definition, involves only individual AE reports. 

The periodic reports play an important role in the risk-benefit evaluation of the drug and involve collective analysis of cases in the database, monitoring regulatory actions, literature searches, etc. They are required to be submitted to various regulatory agencies to comply with the regulatory requirements. The advantage of aggregate reporting is that it provides a broader view of the safety profile of a drug.

Aggregate Reports refers to those reports that focus not so much on individual cases, but rather on overview, assessment of the safety profile, and benefit-risk-evaluation. 

They comprise E.g.

  • Periodic Safety Update Reports (PSURs) / Periodic Benefit Risk Evaluation Reports (PBRERs),
  • Periodic Adverse (Drug) Experience Reports (US),
  • Development Safety Update Reports (DSURs),
  • Integrated Summaries of Safety (US), or
  • Clinical Summaries of Safety (EU)


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