Ksb D03 K0022

Regulatory References

• ICH-E2A
• EMA-GVP-014
• EMA-GVP-015

Instructions

When this skill is activated, Claude should:

1. Demonstrate L4 proficiency in anaphylaxis
2. Apply evaluate level cognitive skills to evaluate the topic
3. Reference relevant regulatory guidance (ICH-E2A, EMA-GVP-014, EMA-GVP-015)
4. Connect to related EPAs: EPA-01, EPA-02, EPA-05

Key Competencies

• Immediate hypersensitivity, severity assessment, emergency management protocols

Assessment Criteria

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

Related Skills

• Other D03 skills in Immunological and Hypersensitivity Reactions
• Cross-domain integrations per DAG architecture

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