ksb-d12-k0001

name	KSB-D12-K0001
description	Global Regulatory Authority Structure: FDA organizational design and decision-making processes, EMA committee systems and scientific advice...
version	1.0.0
domain	D12
domain_name	Industry & Regulatory
type	Knowledge
proficiency_level	L4
bloom_level	create
triggers	["explain global regulatory authority structure","what is global regulatory authority structure","create global regulatory authority structure"]
epa_mapping	EPA-06, EPA-09, EPA-16
cpa_mapping	CPA-04
regulatory_refs	FDA-CFR-004, EMA-REG-001

KSB-D12-K0001: Global Regulatory Authority Structure

Overview

Domain: D12 - Industry & Regulatory Type: Knowledge Proficiency Level: L4 (Proficient - Independent practice) Bloom Level: Create

Description

FDA organizational design and decision-making processes, EMA committee systems and scientific advice procedures, PMDA consultation frameworks, Health Canada regulatory pathways, emerging market regulatory development

Context

• Major Section: Global Regulatory Framework Architecture and Strategic Organizational Response
• Section: Regulatory System Design and Organizational Adaptation

EPA Mapping

• EPA-06:3013-3015
• EPA-09:3020-3022
• EPA-16:3035-3036

CPA Pathway

• CPA-04

Regulatory References

• FDA-CFR-004
• EMA-REG-001

Instructions

When this skill is activated, Claude should:

1. Demonstrate L4 proficiency in global regulatory authority structure
2. Apply create level cognitive skills to create the topic
3. Reference relevant regulatory guidance (FDA-CFR-004, EMA-REG-001)
4. Connect to related EPAs: EPA-06, EPA-09, EPA-16

Key Competencies

• FDA organizational design and decision-making processes, EMA committee systems and scientific advice procedures, PMDA consultation frameworks, Health Canada regulatory pathways, emerging market regulatory development

Assessment Criteria

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

Related Skills

• Other D12 skills in Regulatory System Design and Organizational Adaptation
• Cross-domain integrations per DAG architecture

---

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