Ksb D12 K0046

EPA Mapping

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

CPA Pathway

• CPA-04

Regulatory References

• General PV competency

Instructions

When this skill is activated, Claude should:

1. Demonstrate L3 proficiency in edstp engagement framework
2. Apply apply level cognitive skills to apply the topic
3. Reference relevant regulatory guidance (general PV standards)
4. Connect to related EPAs: EPA-06, EPA-09, EPA-16

Key Competencies

• Understanding of FDA Emerging Digital Safety Technology Program (EDSTP) including eligibility criteria, submission requirements, meeting request procedures, and program benefits for AI/ML pharmacovigilance tools. Knowledge of EDSTP interaction types (pre-submission meetings, written feedback requests, pilot participation), documentation expectations, and strategic timing for regulatory engagement. Comprehension of how EDSTP complements traditional regulatory pathways and CDRH AI/ML initiatives.

Assessment Criteria

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

Related Skills

• Other D12 skills in Emerging Technology Programs
• Cross-domain integrations per DAG architecture

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