Transcription of E 2 D Post Approval Safety Data Management
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European Medicines Agency 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 85 75 Fax (44-20) 75 23 70 40 E-mail: EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged May 2004 CPMP/ICH/3945/03 ICH Topic E 2 D Post Approval Safety data Management Step 5 NOTE FOR GUIDANCE ON DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING (CPMP/ICH/3945/03) TRANSMISSION TO CPMP July 2003 TRANSMISSION TO INTERESTED PARTIES July 2003 DEADLINE FOR COMMENTS October 2003 FINAL Approval BY CPMP November 2003 DATE FOR COMING INTO OPERATION May 2004 EMEA 2006 2 clinical Safety data Management : DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING ICH Harmonised Tripartit
CLINICAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING ICH Harmonised Tripartite Guideline Table of Contents 1. INTRODUCTION 2.
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Clinical Safety Data Management:, Clinical Safety Data Management: Periodic Safety Update Reports, Clinical, Clinical safety data, EU Individual Case Safety Report ICSR, CLINICAL SAFETY DATA MANAGEMENT, Data, Safety, Good Clinical Practice, Guideline, E6R2, Graphical Analyses of Clinical Trial Safety Data, Management, Safety data, DIA Annual Workshop for Clinical Data, DIA Annual Workshop for Clinical Data Management, Clinical data management, Managing Data in Clinical Research, Data Management and Research Informatics Good, Data Management