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ICH Efficacy Guidelines E – Clinical Studies, GCP, E6(R3) & Global Structure

ICH Efficacy Guidelines E – Clinical Studies, GCP, E6(R3) & Global Structure

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€89,00 EUR
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The complete guide to ICH E guidelines, focusing on the new ICH E6(R3), the global standard for Good Clinical Practice.
It is the operational tool for Sponsors, CROs, Clinical Operations, QA/GCP and PV.

Inside you will find:
📘 Principles and structure of E6(R3) and differences from R2.
🏥 Sponsor & CRO Responsibilities , investigator responsibilities and site management.
🧭 Risk-Based Approach in Clinical Trials , RBQM and quality by design.
📁 Trial Master File , essential documents, data integrity & EDC.
⚠️ Complete checklists for sponsors, CROs, sites, TMFs, and pharmacovigilance.
🧩 Integration with ICH E2 guidelines (E2A, E2B(R3), E2D, E2E).

Perfect for internal training, EMA/FDA/MHRA inspections and GCP audits.

Format: Professional PDF
Pages: 79
Updated: December 2025
Languages: ITA – ENG

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Main references for this guide ICH E6(R3) · ICH E8(R1) · ICH E9(R1)
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