Safety Aggregate Reporting 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 a 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 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 a 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-marketing authorization:
- Periodic Adverse Drug Experience Report (PADER).
- Periodic Benefit Risk Evaluation Report (PBRER) or 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 reports (aggregate reporting in pharmacovigilance) timetable/calendars.
- Resource allocation is 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.
Safety Aggregate Reporting Services
- Qualified experts (medical doctors, pharmacy, and life sciences graduates) with domain knowledge
- Support with the creation and maintaining aggregate reporting schedule as per product DIBD, IBD, and EURD list
- Support the development of complex reports such as PBRER, PSURs, and DSURs
- Expertise in handling various report types such as ACOs, IND Annual Reports, Canada Annual Reports, Local PSURs, SSURs, etc both during development and post-authorization
- Language translation capabilities for local safety reports
- Robust documented processes governing aggregate periodic report management which can be customized as per client requirements
- Design and implementation of technology, templates, and procedures required for aggregate reporting
- Quality management processes for ensuring high-quality deliverables
- Expert review by highly experienced medical doctors to ensure the accuracy and consistency of scientific interpretations and conclusions
- In-house publishing and submission teams to ensure seamless delivery and compliance
