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The New Standard in Clinical Trials – ICH E6(R3)・Qbd and Applied Areas (DCT・RWD・AI) – Nov 2025
A complete, three-layered view of the new regulatory landscape from ICH E6(R3) implementation to the re-defined QbD approach, and practical use of DCT, RWD, and AI. Includes Japan-specific considerations and PMDA expectations.