Good Clinical Practice eRegs & Guides - For Your Reference Book 4 by FDA

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

byFDA, Biopharma Advantage Consulting L.L.C., eRegs And Guides a Biopharma Advantage Consulting L.L.C.

Kobo ebook | February 22, 2014

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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 
European Directive 2005/28/EC 

Title:Good Clinical Practice eRegs & Guides - For Your Reference Book 4Format:Kobo ebookPublished:February 22, 2014Publisher:Biopharma Advantage Consulting L.L.C.Language:English

The following ISBNs are associated with this title:

ISBN:9990044041767

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