Aggregate Safety Reports Services - Overview

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 Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), and other aggregate reporting in Pharmacovigilance. Freyr provides proven pharmacovigilance aggregate reporting services, which are considered a large responsibility and take substantial effort.

Pre-approval Aggregate Safety Reports

These aggregate safety reports include the cumulative summary of safety information for molecules under clinical development. They usually include safety information from nonclinical studies and safety data of the subjects who participated in the clinical trial.

Development Safety Update Report (DSUR)

The DSUR document has replaced the traditional reports such as the Annual Safety Reports (ASRs) in Europe and the Investigational New Drug (IND) annual reports in the United States to harmonize the content and ensure the three (03) ICH regions receive information in the same format, thereby reducing the total number of reports generated.

Post-approval Aggregate Safety Reports

These reports provide the cumulative summary of the company’s core safety information for the medicinal products that are already marketed.

The following types of aggregate reports in pharmacovigilance are submitted for medicinal products post the marketing authorization:

  • Periodic Adverse Drug Experience Report (PADER).
  • Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR).
  • Summary Bridging Reports.
  • Addendum Reports.
  • Safety Assessment Reports.
  • Annual Safety Reports (ASRs).
  • Ad-hoc Reports (Based on the HA’s request).

The following strategic-level maintenance activities are planned and executed by Freyr’s 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.

Pharmacovigilance Aggregate Reporting - Freyr Expertise

Freyr has helped global pharmaceutical companies in the preparation and review of the following:

  • Periodic Adverse Drug Experience Report (PADER).
  • Periodic Benefit Risk Evaluation Report (PBRER).
  • Periodic Safety Update Reports (PSUR).
  • Developmental Safety Update Reports (DSURs).
  • Canadian Annual Summary Reports (CASR).
  • 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).