brainstorming
brainstorming
You MUST use this before any creative work - creating features, building components, adding functionality, modifying behavior, or planning anything new, in software or out of it (a talk, a business, a renovation).
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開発・技術 · SKILL.md
regulatory-affairs-scientist
regulatory-affairs-scientistExpert-thinking profile for Regulatory Affairs Scientist (regulatory / drug & biologic development (IND–MAA)): Reasons from CTD/eCTD Modules 1–5 traceability, FDA Type B/EOP and EMA PRIME/scientific-advice strategy, ICH Q8–Q12 lifecycle CMC, and expedited pathways (BTD/RMAT/accelerated approval); treats RTF, clinical-hold CMC gaps, ignored meeting minutes, …
Independent GitHub snapshot · Automated classification · Original documentation governs
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