prepare-assessment-aid-position
SolidStructures the clinical pharmacology content of an assessment aid or applicant's position document — the tabulated summary an agency requests to facilitate their review. Extracts every CP claim, traces it to its source document, verifies internal consistency, and flags any position statement that crosses into a clinical or regulatory decision. Use when asked to prepare or review an assessment aid's CP section. Do not use for drafting agency responses, for meeting preparation, or for taking a position.
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Quality Score: 84/100
Skill Content
Details
- Author
- malekokour
- Repository
- malekokour/clinpharm-pmx-skills
- Created
- 1 weeks ago
- Last Updated
- 6 days ago
- Language
- Python
- License
- MIT
Similar Skills
Semantically similar based on skill content — not just same category
prepare-position-defence-brief
Structures a clinical pharmacology position defence brief — the evidence-backed argument for a CP position the team expects to defend before an agency. Maps the position statement to its evidence chain, identifies vulnerabilities, and assembles counter-arguments with sourced data. Use when preparing a CP position for agency discussion. Do not use for drafting the position itself, for deciding the position, or for predicting what an agency will accept.
author-applicants-position
Drafts and reviews the clinical pharmacology applicant's-position sections of a regulatory briefing package — each position stated as a claim with its scope, the evidence that supports it, the pre-specified rule it rests on, its limitations, and its residual gaps — structured so that every position is auditable against the cited evidence and no position reads as agreed or accepted. Use this skill when someone asks to draft or review applicant's positions for a regulatory interaction, stress-test positions against their evidence, or check that every position is supported. Example: "Please to draft or review applicant's positions for a regulatory interaction, stress-test positions against their evidence." Do not use for the meeting-request letter itself, for responding to questions an agency already sent, for CTD summary content, for the question-set design, or for any request to assert that a position is agreed or will be accepted.
prepare-briefing-package-content
Drafts and reviews the clinical pharmacology portion of a regulatory briefing package — answerable questions to the agency, applicant positions with their supporting evidence, and validated annex cross-references — aligned to the public structure of clinical pharmacology review. Use this skill when someone asks to draft, structure, stress-test or QC the CP content of a briefing book or meeting package — for example "draft the clin pharm section of our pre-NDA briefing package", "which questions should we ask", or "check every position in this package is actually supported". Do not use for responding to questions an agency has already sent, for writing the meeting request itself, for CTD summary or labelling content, or for any request to decide whether a position will be accepted.