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Ethics · Regulation · Technology — Pharma Practice Notes

Reviewer Development & Assessment

Material review depends on people. Here are three designs for growing and assessing those people by structure rather than impression ── an eight-dimension competency framework, a qualification bar for independent review, and a measurement design grounded in behavioral evidence. A commentary on the the internal design specifications as Material Review 2.0 for the AI era.

Introduction — Get the Map First

Dive straight into the details and you will get lost.
Start with the map →

Competency Framework

The reviewer's competence, divided into eight dimensions (detect, push back, embed), each recast through a scope×abstraction quadrant and an L1–L4 scale.
All 10 parts →

The Qualification Bar

The level at which a reviewer may be entrusted with independent review, set not by an average but by non-compensatory gates (floors).
All 10 parts →

Measurement Design

L is never decided by self-report.
All 10 parts →