🔍 Pharmaceutical Advertising Regulation: Material Creation, Review & Use in Japan JP/EN
Ethics · Regulation · Technology — Pharma Practice Notes
Educational·10 episodes total

AI Material Review── How to build AI into material review, and where people keep the reins — in 10 parts

Material review is the work of checking promotional materials against the rules and having deviations fixed. Now generative AI is entering that work. AI makes materials fast and in bulk, surfaces the seeds of deviation by machine, and puts review criteria into words to reduce person-dependence. But a person still decides, at the end, whether it reaches clinicians and patients without misunderstanding. This series covers how to build AI into material review — and where people keep the reins — in 10 parts, grounded in the Pharmaceutical Act and the promotion guidelines.

Basics
01

AI and Material Review — What's Happening Now

AI is entering the review floor. What changes, what stays the same. The opening map of this 10-part series.
Basics
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02

How to Review AI-Generated Materials

Reviewing bulk AI-made materials safely without losing speed. A human-in-the-loop design.
Basics
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03

Detecting Deviations with AI

Catching the seeds of deviation — exaggeration, off-label claims, thin evidence — by machine, to support human judgment.
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Practice
04

Giving AI the Rules — Guardrail Design

Building the Pharmaceutical Act (exaggeration 66 / unapproved 68 / info 68-2) and the promotion guidelines into AI as guardrails.
Practice
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05

Standardizing Review with AI

Putting review criteria into words with AI to reduce person-dependence — a shared yardstick.
Practice
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06

The Power and Limits of AI Review Tools

What review-support tools can and cannot do — the right distance between over-trust and dismissal.
Practice
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07

Review Records and Audit Trails with AI

Keeping review records, audit trails, and CAPA with AI — a traceable, reproducible review.
Practice
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System & Future
08

Reviewers' AI Literacy

The skill of the user: the limits reviewers must know, and the habit of not taking AI at face value.
System
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09

Review Governance in the AI Era

How to design a review system with AI built in — where responsibility sits, and governance that holds.
System
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10

The Future of AI Material Review

How review changes over 5–10 years — dividing roles between people and AI, and the principles to keep.
System
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