[DOWNLOAD] "Good Clinical Practice (GCP) eRegs & Guides - For Your Reference Book 4" by Biopharma Advantage Consulting L.L.C & FDA # Book PDF Kindle ePub Free

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eBook details

• Title: Good Clinical Practice (GCP) eRegs & Guides - For Your Reference Book 4
• Author : Biopharma Advantage Consulting L.L.C & FDA
• Release Date : January 13, 2014
• Genre: Medical,Books,Professional & Technical,Law,
• Pages : * pages
• Size : 4901 KB

Description

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

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