AI for Pharma & Life Sciences - Skill.re

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AI for Pharma & Life Sciences

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474

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35

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100-150 hours

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AI-Assisted Advisory Board Meeting Prep and Post-Meeting Report

reading · M1 · 15 min

AI-Assisted Comparability Protocol Drafting Under ICH Q5E

reading · M2 · 15 min

AI-Assisted Congress Slide Deck Update for MLR Review

reading · M3 · 15 min

AI-Assisted Cover Letter and Module 1 Disclosure of AI Involvement

reading · M4 · 15 min

AI-Assisted Clinical Study Protocol (CSP) Drafting Aligned to ICH M11

reading · M5 · 15 min

AI-Assisted eCTD Section Mapping and Module 1 Hyperlink QC

reading · M6 · 15 min

AI-Assisted Expedited 15-Day Report Drafting

reading · M7 · 15 min

AI-Assisted FDA Form 483 Response Drafting

reading · M8 · 15 min

AI-Assisted FDA Form Drafting: 1571, 1572, 3674, 356h

reading · M9 · 15 min

AI-Assisted Field Insight Synthesis from KOL Meeting Notes

reading · M10 · 15 min

AI-Assisted Form 1571 IND Amendment Lifecycle

reading · M11 · 15 min

AI-Assisted Health Authority Correspondence and Information Request (IR) Responses

reading · M12 · 15 min

AI-Assisted Informed Consent Form (ICF) Drafting and Plain-Language Translation

reading · M13 · 15 min

AI-Assisted ICH M10 Bioanalytical Method Validation Report Drafting

reading · M14 · 15 min

AI-Assisted ICH Q9(R1) Quality Risk Management Documentation

reading · M15 · 15 min

AI-Assisted ICSR Narrative Drafting for E2B(R3) Submission

reading · M16 · 15 min

AI-Assisted Investigator's Brochure (IB) Update

reading · M17 · 15 min

AI-Assisted Literature Surveillance and ICSR Triage

reading · M18 · 15 min

AI-Assisted Module 3.2.P Drug Product Section Drafting

reading · M19 · 15 min

AI-Assisted Module 3.2.S Drug Substance Section Drafting

reading · M20 · 15 min

AI-Assisted Monitoring Visit Report (MVR) Drafting

reading · M21 · 15 min

AI-Assisted Orphan Drug Designation (ODD) Request Drafting

reading · M22 · 15 min

AI-Assisted Pre-IND and Type A / B / C / D Meeting Briefing Book Drafting

reading · M23 · 15 min

AI-Assisted Protocol Deviation Classification and Documentation

reading · M24 · 15 min

AI-Assisted PSUR / PBRER (ICH E2C(R2)) and DSUR (ICH E2F) Section Drafting

reading · M25 · 15 min

AI-Assisted Refuse-to-File (RTF) / Refuse-to-Receive (RTR) Response Drafting

reading · M26 · 15 min

AI-Assisted Source Data Verification (SDV) Sampling and Prioritization

reading · M27 · 15 min

AI-Assisted Signal Detection Documentation

reading · M28 · 15 min

AI-Assisted Site Selection and Feasibility Questionnaire Synthesis

reading · M29 · 15 min

AI-Assisted Standard Response Document (SRD) Drafting for Medical Information

reading · M30 · 15 min

AI-Assisted Type B / Type C Meeting Q&A Preparation

reading · M31 · 15 min

Draft a Module 2.5 Clinical Overview Section from a Phase 3 CSR

reading · M32 · 15 min

Prompt Anatomy for Regulatory and Medical Writing

reading · M33 · 15 min

System Prompts Grounded in ICH and FDA Guidance

reading · M34 · 15 min

The Show Your Sources Prompting Pattern

reading · M35 · 15 min

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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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