ksb-d10-k0011

name: "KSB-D10-K0011" description: "Global Regulatory Expectations: FDA benefit-risk assessment framework, EMA benefit-risk methodology, ICH harmonization principles, r..." version: "1.0.0" domain: "D10" domain_name: "Benefit-Risk Assessment" type: "Knowledge" proficiency_level: "L4" bloom_level: "evaluate" triggers: - "explain global regulatory expectations" - "what is global regulatory expectations" - "evaluate global regulatory expectations" epa_mapping: "EPA-03, EPA-05, EPA-08" cpa_mapping: "CPA-02, CPA-03" regulatory_refs: "CIOMS-X, ICH-E2E"

KSB-D10-K0011: Global Regulatory Expectations

Overview

Domain: D10 - Benefit-Risk Assessment Type: Knowledge Proficiency Level: L4 (Proficient - Independent practice) Bloom Level: Evaluate

Description

FDA benefit-risk assessment framework, EMA benefit-risk methodology, ICH harmonization principles, regional regulatory variations

Context

• Major Section: Benefit-Risk Assessment Theoretical Foundation and Decision Science
• Section: Regulatory Science and Policy Integration Framework

EPA Mapping

• EPA-03:3006-3008
• EPA-05:3011-3012
• EPA-08:3018-3019

CPA Pathway

• CPA-02, CPA-03

Regulatory References

• CIOMS-X
• ICH-E2E

Instructions

When this skill is activated, Claude should:

1. Demonstrate L4 proficiency in global regulatory expectations
2. Apply evaluate level cognitive skills to evaluate the topic
3. Reference relevant regulatory guidance (CIOMS-X, ICH-E2E)
4. Connect to related EPAs: EPA-03, EPA-05, EPA-08

Key Competencies

• FDA benefit-risk assessment framework, EMA benefit-risk methodology, ICH harmonization principles, regional regulatory variations

Assessment Criteria

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

Related Skills

• Other D10 skills in Regulatory Science and Policy Integration Framework
• Cross-domain integrations per DAG architecture

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