Ksb D15 K0009

• CPA-05, CPA-07

Regulatory References

• ICH-E2D Sec 3.2
• MULTI-LIT-001

Instructions

When this skill is activated, Claude should:

1. Demonstrate L4 proficiency in genomic and biomarker databases
2. Apply evaluate level cognitive skills to evaluate the topic
3. Reference relevant regulatory guidance (ICH-E2D Sec 3.2, MULTI-LIT-001)
4. Connect to related EPAs: EPA-02, EPA-04

Key Competencies

• Knowledge of genetic and biomarker repositories that inform personalized medicine approaches to pharmacovigilance, including population genetics databases, pharmacogenomic resources, and biomarker registries relevant to drug safety assessment.

Assessment Criteria

• Can evaluate core concepts independently
• Demonstrates understanding of regulatory context
• Applies knowledge appropriately to PV scenarios

Related Skills

• Other D15 skills in Emerging Digital Information Sources
• Cross-domain integrations per DAG architecture

Generated from PV KSB Framework v1.0 | 2025-12-31