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AI for Pharma & Life Sciences
Strategic
342
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22
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100-150 hours
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Lifetime
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📖
AI Governance: Committee Structure, Decision Rights, Escalation
reading · M1 · 15 min
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AI in the FDA PAI, EMA GCP/GMP Inspection, and the Form 483 / EIR Cycle
reading · M2 · 15 min
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Assessing AI Readiness in a Regulatory or Medical Writing Function
reading · M3 · 15 min
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Building a 24-Month AI Roadmap for Your Function
reading · M4 · 15 min
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Building a Function-Level AI Risk Register
reading · M5 · 15 min
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Building AI Champions: The First Six Power-Users in Your Function
reading · M6 · 15 min
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Business Case Construction for Function-Level AI Investment
reading · M7 · 15 min
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Computer Software Assurance (CSA) vs Validation (CSV) for AI Tools
reading · M8 · 15 min
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Defining Success Metrics: Cycle Time, Query Rate, IR Volume, PDUFA Predictability
reading · M9 · 15 min
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Designing a Part 11 + Annex 11 Validation Protocol for an AI Tool
reading · M10 · 15 min
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Engaging FDA, EMA, PMDA, MHRA, Health Canada, NMPA, TGA on AI in Submissions
reading · M11 · 15 min
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Evaluating the Clinical Operations AI Stack: Medidata, Saama, Lokavant, Medable
reading · M12 · 15 min
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Evaluating the PV AI Stack: ArisGlobal, Oracle Argus AI, IQVIA, Indegene
reading · M13 · 15 min
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Evaluating the Submission AI Stack: Veeva, Certara, Phlex, Narrativa, Cortellis
reading · M14 · 15 min
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GAMP 5 Categories and AI: Where LLM-Based Tools Sit
reading · M15 · 15 min
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Measuring Quality Outcomes: First-Cycle Approval, 483 Frequency, Day 120/180
reading · M16 · 15 min
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Ongoing Performance Monitoring, Drift Detection, and the PCCP Pattern
reading · M17 · 15 min
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Overcoming Resistance in Senior Medical Writers, RA Managers, and PV Leads
reading · M18 · 15 min
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Prioritizing Use Cases: The Deloitte/McKinsey Productivity Frame, Critically Examined
reading · M19 · 15 min
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Reporting AI ROI to the C-Suite and Board
reading · M20 · 15 min
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The AI Section of the Cover Letter and Module 1: Emerging Practice 2026
reading · M21 · 15 min
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Training Programs and Internal Certification Pathways
reading · M22 · 15 min
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course provider
SK
Skill.re
Course provider
FREE ✓ Enroll → lifetime access · 22 lessons
about this course

The 5-level, role-by-role AI certification for the people who actually ship the dossier: regulatory affairs, medical writers, MSLs, clinical operations, pharmacovigilance writers, and CMC. Built for the post-January-2026 world where FDA and EMA finally agree on what 'good AI practice' looks like inside a regulated submission. Every lesson moves a named artifact a real desk owns: Module 2.5 Clinical Overview, CSP under ICH M11, ICSR narrative under E2B(R3), comparability protocol under ICH Q5E, Type C briefing book, FDA Form 483 response, PSUR under ICH E2C(R2), and the AI section of the cover letter.

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The Strategic certificate

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Strategic certificate
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22 lessons