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Aggregate Reporting

To protect the safety and efficacy of a drug, the Marketing Authorization Holder (MAH) must conduct pharmacovigilance aggregate reporting and safety writing and periodically submit the aggregate safety reports, also known as periodic reports or periodic safety reports, to the Health Authorities (HAs).

Based on the marketing authorization status, the MAH must prepare different types of reports, including pre-approval aggregate reports and post-marketing aggregate reports, primarily Periodic Safety Update Reports (PSURs) or Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), and other aggregate reporting in Pharmacovigilance.

IGRS provides proven pharmacovigilance aggregate reporting services, which are considered a large responsibility and take substantial effort. We provide complete tailormade module for collections, processing and submissions of aggregate report as per the customer’s requirements for pharmaceuticals, herbal products and medical devices.

 

The following strategic-level maintenance activities are planned and executed by IGRS team of experts:

  • Creation/Maintenance of periodic safety report (aggregate reporting in Pharmacovigilance) timetable/calendars.

  • Resource allocation based on expertise and skill set.

  • Classification of aggregate reports.

  • Tracking and managing the preparation of reports based on pharmacovigilance aggregate reporting period and database lock.

  • Preparation of line listings and tabulation.

  • Medical review of the draft.

  • Submission to the HA.

  • Compliance with the HA timelines.

  • Handling and answering the HA queries.

 

IGRS provide support in following activities of Aggregate reporting

  • Periodic Safety Update Reports (PSUR).

  • Developmental Safety Update Reports (DSURs).

  • Periodic Adverse Drug Experience Report (PADER).

  • Periodic Benefit Risk Evaluation Report (PBRER).

  • Risk Management Plans (RMPs).

  • Risk Evaluation and Mitigation Plans (REMPs).

  • Addendum Clinical Overviews (ACOs).

  • ADR Reporting/Monitoring Services.

  • Pharmacovigilance Aggregate Reporting Services (PV).

  • Safety Assessment Reports (SARs).

  • Safety Narratives (Brief and Full Narratives).

  • Annual Safety Reports (ASRs).

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