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

Nonfiction, Health & Well Being, Medical, Reference, Drug Guides, Research

• Author: FDA, Biopharma Advantage Consulting L.L.C., eRegs And Guides a Biopharma Advantage Consulting L.L.C.
• ISBN: 1230000220417
• Publisher: Biopharma Advantage Consulting L.L.C.
• Publication: February 22, 2014
• Language: English

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