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E 2 D Post Approval Safety Data Management

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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  Management, Data, Safety, Clinical, Clinical safety data management, Safety data management

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