prepare-briefing-package-content

# Briefing Package Content Draft the clinical pharmacology content of a regulatory briefing package: the questions the sponsor puts to the agency, the positions the sponsor takes, the evidence each position rests on, and the annex cross-references that let a reviewer follow a claim to its source. Then stress-test that content against the public shape of clinical pharmacology review, before an agency does. **This skill prepares. It never commits, never asserts that a position is agreed, and never predicts what an agency will decide.** ## Who this is for Clinical pharmacology leads preparing content for a scheduled agency interaction · CP reviewers checking a draft package before it reaches regulatory affairs · regulatory strategy partners assembling the CP portion of a briefing book. ## When to use this skill Use when the object is **content the sponsor is preparing to put in front of an agency**, and no agency question has been received: - "Draft the clinical pharmacology section of our pre-NDA briefing package" - "Which clin pharm questions should we ask at this meeting?" - "Check that every position in this draft is actually supported by an annex" - "Stress-test our dose-selection position before the meeting" - "Are we contradicting anything we told them last time?" ## When NOT to use this skill These are close neighbours. Route them elsewhere and say so: | Request | Why not this skill | Where it belongs | |---|---|---| | "The agency sent us these questions — map ...