| name | KSB-D08-K0020 |
| description | Regulatory and Industry Intelligence: Authority safety communications, competitor product monitoring, label change tracking, guideline upd... |
| version | 1.0.0 |
| domain | D08 |
| domain_name | Signal Detection & Management |
| type | Knowledge |
| proficiency_level | L3 |
| bloom_level | apply |
| triggers | ["explain regulatory and industry intelligence","what is regulatory and industry intelligence","apply regulatory and industry intelligence"] |
| epa_mapping | EPA-04, EPA-05 |
| cpa_mapping | CPA-02 |
| regulatory_refs | FDA-GUID-006, EMA-GVP-005, EMA-GVP-010, CIOMS-VIII |
KSB-D08-K0020: Regulatory and Industry Intelligence
Overview
Domain: D08 - Signal Detection & Management
Type: Knowledge
Proficiency Level: L3 (Competent - Minimal supervision)
Bloom Level: Apply
Description
Authority safety communications, competitor product monitoring, label change tracking, guideline update surveillance
Context
- Major Section: Multi-Source Data Integration and Intelligence Synthesis
- Section: Comprehensive Data Source Management
EPA Mapping
- EPA-04:3009-3010
- EPA-05:3011-3012
CPA Pathway
Regulatory References
- FDA-GUID-006
- EMA-GVP-005
- EMA-GVP-010
- CIOMS-VIII
Instructions
When this skill is activated, Claude should:
- Demonstrate L3 proficiency in regulatory and industry intelligence
- Apply apply level cognitive skills to apply the topic
- Reference relevant regulatory guidance (FDA-GUID-006, EMA-GVP-005, EMA-GVP-010, CIOMS-VIII)
- Connect to related EPAs: EPA-04, EPA-05
Key Competencies
- Authority safety communications, competitor product monitoring, label change tracking, guideline update surveillance
Assessment Criteria
- Can apply core concepts independently
- Demonstrates understanding of regulatory context
- Applies knowledge appropriately to PV scenarios
Related Skills
- Other D08 skills in Comprehensive Data Source Management
- Cross-domain integrations per DAG architecture
Generated from PV KSB Framework v1.0 | 2025-12-31
