Overview

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

Based on the marketing authorization status, the MAH usually must prepare different types of reports, including pre-approval aggregate safety reports and post-approval aggregate safety reports primarily Periodic Benefit Risk Evaluation Report (PBRER), Periodic Adverse Drug Experience Reports (PADER), and various other types of reports. Thus, Pharmacovigilance aggregate reporting is considered a large responsibility and takes substantial effort.

Pre-approval Safety-related Aggregate Reports

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

Development Safety Update Report (DSUR)

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

Post-approval Safety-related Aggregate 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 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 HA request)

Freyr strategic level maintenance activities are planned and executed as below:

  • Creation/Maintenance of periodic safety report (aggregate report) timetable/calendars
  • Resource allocation based on the expertise and skill set
  • 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 responding to the HA queries
 

Freyr Expertise

Preparation and Review of:

  • 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)