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The Renovation of Good Clinical Practice: A Framework for Key Components of ICH E8

Madeleine Whitehead1, Melissa Suprin2, Tashan Mistree3

  • 1Roche, Hexagon Place, Shire Park, Falcon Way, Welwyn Garden City, AL7 1TW, UK. madeleine.whitehead@roche.com.

Therapeutic Innovation & Regulatory Science
|December 1, 2023
PubMed

Keywords:
Critical thinkingCritical to quality factorsCtQE8Fit for purposeOpen dialogueQbDQuality by designStakeholder engagement

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