prepare-midd-engagement-packagelisted

# MIDD Regulatory Engagement Package Assemble the clinical pharmacology content of a Model-Informed Drug Development regulatory engagement package: the modelling question the sponsor is bringing to the agency, the model's stated context of use, the qualification or fitness-for-purpose argument, the key assumptions with their sensitivity analyses, and the decision the model output informs — structured so that every element traces to its source and no model-derived conclusion is stated as a fact the model alone establishes. **This skill assembles and reviews. It never runs or fits a model, never declares a model qualified, and never states that a model output justifies a dose or a regulatory decision.** ## Who this is for Clinical pharmacology and pharmacometrics leads assembling a MIDD engagement package for an agency interaction · CP reviewers checking that every modelling claim is evidence-backed before submission · regulatory strategy partners verifying the package structure matches guidance expectations. ## When to use this skill - "Assemble the MIDD package for our PBPK-based DDI waiver" - "Review the fitness-for-purpose argument in our PopPK submission" - "Map every model assumption to its sensitivity analysis" - "Check that our context of use is stated and evidenced" - "Is anything in this MIDD package asserted without a source?" ## When NOT to use this skill | Request | Why not this skill | Where it belongs | |---|---|---| | "Run the PopPK model with updated da