[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
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