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

• Author(s): eRegs & Guides, Biopharma Advantage Consulting L.LC. ,
• Publisher: eregs & guides
• Pages: 390
• Language: en
• Categories: Biography & Autobiography / Medical , Medical / General , Business & Economics / Industries / Pharmaceutical & Biotechnology , Medical / Nursing / General , Medical / Reference , Medical / Research , Science / Biotechnology ,

Description:... 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