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

Download or read book Good Clinical Practice eRegs & Guides - For Your Reference Book 4 written by eRegs & Guides and published by eregs & guides. This book was released on 2013-11-22 with total page 390 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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