prepare-meeting-strategy

Solid

Structures the clinical pharmacology input to an agency meeting strategy — identifying which CP topics warrant discussion, mapping each to the available meeting types (Type A/B/C for FDA; scientific advice, protocol assistance for EMA), and building the briefing package that supports the requested meeting type. Use when preparing or reviewing the CP contribution to a meeting request. Do not use for drafting the meeting request itself, for rehearsal coaching, or for taking a negotiating position.

AI & Automation 6 stars 0 forks Updated 6 days ago MIT

Install

View on GitHub

Quality Score: 84/100

Stars 20%
28
Recency 20%
100
Frontmatter 20%
70
Documentation 15%
100
Issue Health 10%
80
License 10%
100
Description 5%
100

Skill Content

# Agency Meeting Strategy and Type Selection Meeting strategy and type selection — produce a source-linked finding register a qualified reviewer can act on. Every finding carries a locator, a severity, and a detection path. The register arrives open; only a named human may close an item. > **Skills review, reconcile, verify, structure and flag. Qualified humans > decide, approve, sign off, submit and act.** ## Who this is for Clinical pharmacology or pharmacometrics practitioners working in **Agency engagement** who need a bounded, repeatable review of this L3 task — not a decision, not a draft to submit, and not a substitute for the accountable human owner. ## When to use this skill - "What CP topics should we raise in our Type B meeting?" - "Build the CP briefing package for our EMA scientific advice" - "Does our meeting strategy cover the DDI waiver question?" ## When NOT to use this skill These are close neighbours. Route them elsewhere and say so: | Request | Why not this skill | Where it belongs | |---|---|---| | Draft the meeting request letter | Outward-facing document | Regulatory affairs under human control | | Rehearse the agency meeting | Meeting conduct | Meeting owner | | Take a position on what to concede | Negotiation decision | Qualified reviewer | ## Required inputs Ask for these by artifact, not by category. If one is missing, say which check it disables rather than proceeding silently. | # | Input | Form | Role | |---|---|---|---| | I1 | Draft ...

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

AI & Automation Solid

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.

6 Updated 6 days ago
malekokour
AI & Automation Solid

prepare-assessment-aid-position

Structures 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.

6 Updated 6 days ago
malekokour
AI & Automation Solid

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.

6 Updated 6 days ago
malekokour