PSUR Regulatory Writer
Automate ICH-compliant PSUR drafting with structured safety narratives
What You Can Do
You can streamline periodic safety update report (PSUR) preparation by leveraging Claude to analyze pharmacovigilance data, structure regulatory narratives according to ICH E2C(R2) guidelines, and generate quality summaries of safety signals and efficacy outcomes. The skill extracts critical safety findings from raw data, cross-references regulatory requirements, and produces compliant document sections ready for regulatory submission.
Features
Automatically extract and categorize adverse events, serious adverse events, and safety signals from clinical and post-marketing data. Identify trends, frequency patterns, and emerging safety concerns to highlight in your PSUR.
Generate PSUR sections that follow International Council for Harmonisation formatting requirements, including safety specification updates, pharmacovigilance plan summaries, and cumulative benefit-risk assessments.
Create pre-filled regulatory narratives for each section (executive summary, overview of annual safety data, ongoing development program results). Adapt templates to your specific drug characteristics and patient populations.
Flag new adverse events, previously unreported safety signals, and potential causal relationships. Prioritize findings by severity, frequency, and regulatory impact for inclusion in your update.
Organize safety literature, published studies, and external data sources into narrative format. Cross-reference findings with your pharmacovigilance data to build comprehensive safety arguments.
Synthesize safety and efficacy data to draft balanced benefit-risk conclusions. Structure qualitative and quantitative evidence to support regulatory determinations and labeling recommendations.
Verify your draft against ICH E2C(R2) requirements, EMA guidelines, and regional regulatory standards. Identify gaps, missing data, or formatting issues before submission.
Example Output
Executive Summary Section:
During the reporting period (January-December 2025), 1,247 adverse events were reported, including 89 serious adverse events. Signal analysis identified three new potential safety issues: hepatotoxicity (n=12, causality assessment: probable/possible) correlating with cumulative dose above 2,400 mg; QT prolongation (n=8) in patients aged 65+ on concurrent medications; and rare Stevens-Johnson syndrome variant (n=2). Existing safety profile remained consistent with known risks in the 2024 PSUR.
Signal Summary Table:
| Signal | Frequency | Outcome | Recommendation |
|---|---|---|---|
| Hepatotoxicity | 12 cases | 2 resolved, 1 hospitalized | Revise dosing guidance |
| QT Prolongation | 8 cases | All resolved post-treatment | Add drug interaction warning |
| SJS Variant | 2 cases | Recovered with sequelae | Monitor and report |
Benefit-Risk Conclusion Draft: The benefit-risk profile remains favorable for [indication] in eligible patients. New safety signals require dose optimization and enhanced monitoring in at-risk populations, supporting conditional approval with enhanced pharmacovigilance.
What's Included
- PSUR Section Templates: Pre-formatted sections for executive summary, safety specification, pharmacovigilance plan overview, and benefit-risk evaluation, aligned with ICH E2C(R2) requirements.
- Data Extraction Framework: Structured prompts and parsing logic to convert raw safety databases, clinical trial data, and post-marketing reports into organized event summaries and trend analysis.
- Regulatory Reference Checklist: ICH E2C(R2), EMA PSUR guidance, FDA safety update requirements, and regional submission standards to guide narrative development and ensure compliance.
- Signal Detection Workflow: Systematic approach to identify new adverse events, evaluate causality, quantify frequency, and prioritize findings for inclusion in your regulatory narrative.
- Quality Control Prompts: Verification questions and compliance checks to review drafts against regulatory standards before final submission to authorities.
Who It's For
- Regulatory Affairs Managers
- Pharmacovigilance Specialists
- Medical Safety Leads
- Clinical Development Directors
- Drug Safety Consultants
Best For
- Periodic Safety Update Report (PSUR) preparation
- Adverse event data structuring and narrative synthesis
- Safety signal analysis and prioritization
- Regulatory compliance verification
- Benefit-risk assessment documentation
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