ksb-d13-k0048

name	KSB-D13-K0048
description	International AI Harmonization: Understanding of international coordination challenges for AI in pharmacovigilance including cross-b...
version	1.0.0
domain	D13
domain_name	Global PV & Public Health
type	Knowledge
proficiency_level	L4
bloom_level	evaluate
triggers	["explain international ai harmonization","what is international ai harmonization","evaluate international ai harmonization"]
epa_mapping	EPA-18, EPA-19
cpa_mapping	CPA-06, CPA-07
regulatory_refs

KSB-D13-K0048: International AI Harmonization

Overview

Domain: D13 - Global PV & Public Health Type: Knowledge Proficiency Level: L4 (Proficient - Independent practice) Bloom Level: Evaluate

Description

Understanding of international coordination challenges for AI in pharmacovigilance including cross-border data sharing for AI training, regulatory recognition of AI validations, harmonized AI performance standards, and global AI governance frameworks.

Context

• Major Section: AI in Global Pharmacovigilance
• Section: Cross-Border AI Coordination

EPA Mapping

• EPA-18:3039-3040
• EPA-19:3041-3042

CPA Pathway

• CPA-06, CPA-07

Regulatory References

• General PV competency

Instructions

When this skill is activated, Claude should:

1. Demonstrate L4 proficiency in international ai harmonization
2. Apply evaluate level cognitive skills to evaluate the topic
3. Reference relevant regulatory guidance (general PV standards)
4. Connect to related EPAs: EPA-18, EPA-19

Key Competencies

• Understanding of international coordination challenges for AI in pharmacovigilance including cross-border data sharing for AI training, regulatory recognition of AI validations, harmonized AI performance standards, and global AI governance frameworks.

Assessment Criteria

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

Related Skills

• Other D13 skills in Cross-Border AI Coordination
• Cross-domain integrations per DAG architecture

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