Good Clinical Practice eRegs & Guides - For Your Reference Book 4
eRegs & Guides · Biopharma Advantage Consulting L.LC.
Nov 2013 · Good Clinical Practice eRegs & Guides - For Your Reference Book 4 · eregs & guides
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Good Clinical Practice For Your Reference - Book 4
ICH - Clinical Safety E1 - E2F
ICH-E1 The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-term Treatment of Non-Life-Threatening Conditions
ICH-E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
ICH-E2B(R2) Clinical Safety Data Management : Data Elements for Transmission of Individual Case Safety Reports
ICH-E2C(R1) Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs
ICH-E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting
ICH-E2E Pharmacovigilance Planning
ICH-E2F Development Safety Update Report
Samples of DSURS
European Directive 2001/20/EC
ICH - Clinical Safety E1 - E2F
ICH-E1 The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-term Treatment of Non-Life-Threatening Conditions
ICH-E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
ICH-E2B(R2) Clinical Safety Data Management : Data Elements for Transmission of Individual Case Safety Reports
ICH-E2C(R1) Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs
ICH-E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting
ICH-E2E Pharmacovigilance Planning
ICH-E2F Development Safety Update Report
Samples of DSURS
European Directive 2001/20/EC
European Directive 2005/28/EC
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