Writing Aggregate Safety Reports: PSUR/PBRER
Preparing an aggregate safety report requires the medical or regulatory writer to organise complex safety, exposure, clinical and benefit-risk information into a scientifically accurate and regulatory-compliant document.
An important post-authorisation aggregate report is the Periodic Safety Update Report (PSUR). The modern PSUR format used in the European Union is based on the Periodic Benefit-Risk Evaluation Report (PBRER) described in ICH E2C(R2).
Role of the Medical Writer
Preparation of a PSUR/PBRER is generally a multidisciplinary activity involving pharmacovigilance, medical, regulatory and other subject-matter experts.
The medical writer may contribute by:
- Developing and maintaining the report structure.
- Coordinating content from different contributors.
- Reviewing source documents and supporting data.
- Drafting and editing report sections.
- Ensuring terminology is clear and consistent.
- Maintaining consistency between sections.
- Managing references and supporting documentation.
- Incorporating reviewer comments.
- Supporting document version control.
- Preparing the report for final review and approval.
The writer should work closely with pharmacovigilance and medical experts because interpretation of safety signals and benefit-risk conclusions requires appropriate subject-matter expertise.
Planning the Report
Effective preparation begins with appropriate planning.
Important considerations include:
- Applicable regulatory requirements
- Reporting period
- Data Lock Point (DLP)
- Product or active substance covered
- Reference safety information
- Required report sections
- Sources of safety and exposure data
- Responsibilities of individual contributors
- Review and approval timelines
- Submission deadline
A clear writing and review schedule helps ensure that information from multiple contributors can be incorporated and evaluated before submission.
Collecting Source Information
Information used in a PSUR/PBRER may originate from multiple functions and data sources.
Examples include:
- Pharmacovigilance databases
- Clinical-trial information
- Post-authorisation studies
- Scientific literature
- Exposure data
- Regulatory actions
- Safety signals
- Risk-management activities
- Product information
- Relevant benefit and effectiveness information
Writers should ensure that information presented in different sections is internally consistent and traceable to appropriate source data.
Writing the Report
A PSUR/PBRER should present information clearly and objectively.
Good writing practices include:
- Using precise scientific and medical terminology.
- Distinguishing interval data from cumulative information where required.
- Presenting tables and figures consistently.
- Avoiding unnecessary repetition between sections.
- Explaining important changes from previous reporting periods.
- Maintaining consistency between narrative discussion and supporting data.
- Clearly presenting conclusions arising from the evaluation.
The report should not simply reproduce accumulated data. The information should support a meaningful scientific evaluation of the medicinal product.
Benefit-Risk Evaluation
A major feature of the PBRER framework is the integration of safety information with relevant information concerning the benefits of the medicinal product.
The report should support evaluation of whether new information changes the overall benefit-risk balance.
The medical writer may help structure and clearly communicate this assessment, but the scientific conclusions should be developed and approved by appropriately qualified pharmacovigilance, medical and regulatory experts.
Quality Review
Before finalisation, the report should undergo appropriate scientific, medical, regulatory and quality review.
Review should confirm:
- Accuracy of information
- Consistency of data
- Completeness of required sections
- Appropriate interpretation of findings
- Correct references
- Consistency with reference safety information
- Resolution of reviewer comments
- Compliance with applicable format and regulatory requirements
Document-control procedures should ensure that the approved version is clearly identified and retained.
Importance of Effective PSUR/PBRER Writing
A well-prepared PSUR/PBRER enables regulatory authorities to understand the evolving safety profile and benefit-risk balance of a medicinal product.
Effective aggregate-report writing therefore requires a combination of pharmacovigilance knowledge, scientific writing, data interpretation, regulatory awareness, multidisciplinary collaboration and document-management skills.
You may be interested in the programs below:
