prepare-meeting-strategylisted

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.
malekokour/clinpharm-pmx-skills · ★ 6 · AI & Automation · score 77

Install: claude install-skill malekokour/clinpharm-pmx-skills

# 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