Transcription of Electronic Transmission of Individual Case Safety Reports ...
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Electronic Transmission of Individual Case Safety Reports ...
Electronic Transmission of Individual case Safety Reports Message Specification Document Version November 9, 2000 ICH ICSR Specifications ICH ICSR DTD Version November 2000 -1- INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH M2 EWG Electronic Transmission of Individual case Safety Reports Message Specification (ICH ICSR DTD Version ) Final Version Document Revision February 1, 2001 Rapporteur Greg Brolund Associate Director for Technology Policy and Standards Office of Information Technology Center for Drug Evaluation and Research (CDER) Food and Drug Administration 5600 Fishers Lane, Room 12A43 Rockville, MD 20857 This Specification has been developed by the ICH M2 Expert Working Group in accordance with the ICH Process as it pertains to the M2 EWG.
Electronic Transmission of Individual Case Safety Reports Message Specification Document Version 2.3 November 9, 2000 ICH ICSR Specifications ICH ICSR DTD Version 2.1 November 2000
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