PSUR Compiler & Reviewer
Compile regulatory-compliant PSURs with signal assessment and multi-jurisdiction support
What You Can Do
You can assemble comprehensive Periodic Safety Update Reports by organizing adverse event data, laboratory findings, literature, and post-marketing information into cohesive regulatory narratives. Claude systematically evaluates emerging safety signals, generates required statistical tables, and audits draft PSURs against regulatory checklists—while you retain all scientific judgment and causality assessment decisions.
Features
Example Output
Example 1: Safety Signal Assessment
Input: Summary of 45 reports of liver enzyme elevation in patients on Drug X over 18 months
Output:
Signal Summary: Hepatic Transaminitis
- Cases Identified: 45 / ~150,000 exposed patients (0.03%)
- Temporal Pattern: Clustered in months 6-14; declining trend in last 4 months
- Risk Factors: 7/45 (16%) had baseline elevated AST; 12/45 (27%) concurrent hepatotoxic agents
- Severity: 38 Grade 1-2 (reversible); 7 Grade 3 (required intervention)
- Recommendation: Signal warrants investigation; recommend dechallenge protocol review and patient labeling update consideration
Example 2: PSUR Executive Summary Draft
Output:
This PSUR covers safety data accumulated from [DATE] through [DATE] across [REGION].
The benefit-risk profile remains favorable. Key findings:
• 12,450 ICSRs received (serious: 2,340; 18.8%)
• No new safety signals identified
• Hepatic transaminitis signal from prior PSUR shows declining trend
• Risk mitigation measures (updated labeling, post-marketing study) on track
What's Included
- PSUR-Compiler-Reviewer.md: Core instruction file with signal assessment frameworks and section-by-section guidance
- PSUR Data Synthesis Template: Spreadsheet mapper for organizing ICSRs, lab findings, and special population data
- Signal Evaluation Checklist: Structured framework for systematic signal assessment (frequency, temporal patterns, dechallenge/rechallenge, risk factors)
- PSUR Compliance Audit Checklist: ICH guideline-aligned verification checklist covering all required sections and tables
- Regional Requirement Reference Guide: EMA, FDA, PMDA, Health Canada PSUR formatting and content specifications
Who It's For
- Pharmacovigilance Specialists compiling routine and non-routine PSURs across therapeutic areas
- Regulatory Affairs Managers overseeing PSUR timelines and regulatory submissions
- Safety Scientists evaluating emerging signals and risk-benefit profiles pre-submission
- Clinical Safety Monitors synthesizing accumulated safety data from post-marketing surveillance
- Quality Assurance Teams auditing and verifying draft PSURs before regulatory filing
Best For
- Compiling annual, biennial, or protocol-specified PSURs for approved drugs
- Synthesizing safety data from multiple heterogeneous sources (ICSRs, lab abnormalities, literature, special populations) into unified narratives
- Systematically evaluating potential safety signals and trending known signals across reporting periods.
- Generating and verifying required statistical tables and demographic breakdowns for regulatory submission.
- Pre-submission auditing of draft PSURs against ICH guideline checklists and regional compliance requirements
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