ThomasMoreAI KSB-D10-K0012: Regulatory Decision Support
Overview
Domain: D10 - Benefit-Risk Assessment Type: Knowledge Proficiency Level: L1 (Novice - Direct supervision required) Bloom Level: Understand
Description
Advisory committee preparation, regulatory submission strategies, post-marketing commitment planning, risk evaluation and mitigation strategies
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:
- Demonstrate L1 proficiency in regulatory decision support
- Apply understand level cognitive skills to explain the topic
- Reference relevant regulatory guidance (CIOMS-X, ICH-E2E)
- Connect to related EPAs: EPA-03, EPA-05, EPA-08
Key Competencies
- Advisory committee preparation, regulatory submission strategies, post-marketing commitment planning, risk evaluation and mitigation strategies
Assessment Criteria
- Can explain 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