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To address this need, ICH recently published training materials titled "Interpretation and Application of ICH E6(R3): Good Clinical Practice Guideline." Modules 1.1, 1.2, and 1.3 of these materials can be found on the ICH website: Link to the recordings and transcripts can be found at: #FDA #EMA #ICH #GCP #DrugDevelopment #RegulatoryAffairs #MedicalWriting #BioPharma To view or add a comment, sign in The latest edition of the FDA Pulse series covers leadership changes at the Office of Orphan Products Development, new CMS guidance excluding orphan drugs from pricing negotiations, and recent allergen threshold discussions

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