Ksb D02 K0019

Regulatory References

• ICH-E2A
• FDA-GUID-001

Instructions

When this skill is activated, Claude should:

1. Demonstrate L4 proficiency in pregnancy and lactation
2. Apply evaluate level cognitive skills to evaluate the topic
3. Reference relevant regulatory guidance (ICH-E2A, FDA-GUID-001)
4. Connect to related EPAs: EPA-01, EPA-02, EPA-05

Key Competencies

• Teratogenicity assessment, maternal-fetal safety considerations

Assessment Criteria

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

Related Skills

• Other D02 skills in Special Population Considerations
• Cross-domain integrations per DAG architecture

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