Good Clinical Practice (GCP) eRegs & Guides - For Your Reference Book 4
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- 239,00 Kč
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- 239,00 Kč
Publisher 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
GENRE
Professional & Technical
RELEASED
2014
13 October
LANGUAGE
EN
English
LENGTH
305
Pages
PUBLISHER
Biopharma Advantage Consulting L.L.C.
SIZE
4.9
MB
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