Good Clinical Practice (GCP) eRegs & Guides - For Your Reference Book 4 Good Clinical Practice (GCP) eRegs & Guides - For Your Reference Book 4

Good Clinical Practice (GCP) eRegs & Guides - For Your Reference Book 4

    • $129.00
    • $129.00

Descripción editorial

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(R2) 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

GÉNERO
Técnicos y profesionales
PUBLICADO
2014
13 de octubre
IDIOMA
EN
Inglés
EXTENSIÓN
305
Páginas
EDITORIAL
Biopharma Advantage Consulting L.L.C.
VENTAS
Biopharma Advantage Consulting L.L.C.
TAMAÑO
4.9
MB

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