AI for Pharma & Life Sciences - Skill.re

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AI for Pharma & Life Sciences

Proficient

204

learners

31

lessons

100-150 hours

duration

Lifetime

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FREE

price

Level Aware Capable Proficient Strategic Visionary

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AI-Assisted Accelerated Approval Surrogate-Endpoint Defense and Confirmatory Trial Plan Under FDORA

reading · M1 · 15 min

AI-Assisted AdComm Rehearsal Binder, Voter Modeling, and Post-AdComm Minutes

reading · M2 · 15 min

AI Output Audit Trail Construction Under 21 CFR Part 11 and EU Annex 11

reading · M3 · 15 min

Bias Detection in Clinical AI: Subgroup, Site, and Endpoint

reading · M4 · 15 min

Building a Validated AI Workflow Spec: The IQ/OQ/PQ Mindset for AI Tools

reading · M5 · 15 min

Designing the Human-AI Handoff in a Regulated Workflow

reading · M6 · 15 min

End-to-End AI Workflow for Biosimilar 351(k) Analytical Similarity

reading · M7 · 15 min

End-to-End AI Workflow for eTMF QC and Inspection Readiness

reading · M8 · 15 min

End-to-End AI Workflow for Field Insight Capture, Synthesis, and Strategic Reporting

reading · M9 · 15 min

End-to-End AI Workflow for the ICH Q5E Comparability Protocol Lifecycle

reading · M10 · 15 min

End-to-End AI Workflow for ICSR Intake, Triage, Narrative, and E2B(R3) Submission

reading · M11 · 15 min

End-to-End AI Workflow for Literature Surveillance

reading · M12 · 15 min

End-to-End AI Workflow for Module 2.3 Quality Overall Summary

reading · M13 · 15 min

End-to-End AI Workflow for Module 2.4 Nonclinical Overview

reading · M14 · 15 min

End-to-End AI Workflow for Module 2.5 Clinical Overview Production

reading · M15 · 15 min

End-to-End AI Workflow for Module 2.7 Clinical Summaries

reading · M16 · 15 min

End-to-End AI Workflow for Module 3.2.P Drug Product Sections

reading · M17 · 15 min

End-to-End AI Workflow for Module 3.2.S Drug Substance Sections

reading · M18 · 15 min

End-to-End AI Workflow for Oncology Dose-Optimization Under CDER Project Optimus

reading · M19 · 15 min

End-to-End AI Workflow for Post-Approval Change Management (PACMP, CBE, PAS, Type II)

reading · M20 · 15 min

End-to-End AI Workflow for PSUR / PBRER (ICH E2C(R2)) Production

reading · M21 · 15 min

End-to-End AI Workflow for Real-World Evidence Study Reporting

reading · M22 · 15 min

End-to-End AI Workflow for Risk-Based Monitoring (RBM) Under ICH E6(R3)

reading · M23 · 15 min

End-to-End AI Workflow for Scientific Publication Planning Under GPP 2022

reading · M24 · 15 min

End-to-End AI Workflow for Signal Detection, Validation, and RMP Update

reading · M25 · 15 min

End-to-End AI Workflow for Study Start-Up

reading · M26 · 15 min

Hallucination Detection Protocols for Regulatory Documents

reading · M27 · 15 min

Mapping a Regulated Workflow for AI Integration

reading · M28 · 15 min

Persona-Engineered Reviewers and the Fatal-Flaw Reviewer Dossier

reading · M29 · 15 min

Retrieval-Augmented Generation (RAG) Over Your Submission Library

reading · M30 · 15 min

Structured Output for Submission-Ready Content

reading · M31 · 15 min

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FREE ✓ Enroll → lifetime access · 31 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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AI FOR PHARMA & LIFE SCIENCES

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Required: 31 lessons