Transcription of Guideline on Data Monitoring Committee
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Guideline on Data Monitoring Committee
european Medicines Agency Pre-authorisation Evaluation of Medicines for Human Use 7 W estferry Circus, Canary W harf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 86 13 E-mail: EMEA 2005 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged London, 27 July 2005 Doc. Ref. EMEA/CHMP/EWP/5872/03 Corr Committee FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) Guideline ON data Monitoring COMMITTEES DRAFT AGREED BY THE EFFICACY WORKING PARTY October 2003 September 2004 ADOPTION BY Committee FOR RELEASE FOR CONSULTATION November 2004 END OF CONSULTATION (DEADLINE FOR COMMENTS) May 2005 AGREED BY WORKING PARTY June 2005 ADOPTION BY Committee July 2005 DATE FOR COMING INTO EFFECT January 2006 EMEA/ CHMP/EW P/5872/03 Corr Page 2/8 EMEA 2005 Guideline ON data Monitoring COMMITTEES TABLE OF CONTENTS 3 1.
European Medicines Agency Pre-authorisation Evaluation of Medicines for Human Use 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 …
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