Transcription of ICH Topic E 2 C Clinical Safety Data Management: …
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ICH Topic E 2 C Clinical Safety Data Management: …
The European Agency for the Evaluation of Medicinal ProductsHuman Medicines Evaluation UnitICH - Technical Coordination - R. Bass7 Westferry Circus, Canary Wharf, London E14 4HB, UKTel: (+44-171) 418 84 11 Fax: (+44-171) 418 85 51E_Mail: Topic E 2 CClinical Safety data Management: Periodic Safety Update Reports for Marketed DrugsStep 4, Consensus Guideline, 6 November 1996 NOTE FOR GUIDANCE ON Clinical Safety DATAMANAGEMENT: PERIODIC Safety UPDATE REPORTS FORMARKETED DRUGS (CPMP/ICH/288/95) *TRANSMISSION TO CPMPD ecember 1995 TRANSMISSION TO INTERESTED PARTIESD ecember 1995 COMMENTS REQUESTED BEFOREJune 1996 FINAL APPROVAL BY CPMP18 December 1996 DATE FOR COMING INTO OPERATION(STUDIES COMMENCING AFTER)18 June 1997 * including post Step 4 correctionsCPMP/ICH/288/95, Jan.
CPMP/ICH/288/95, Jan. 97 1/22 CLINICAL SAFETY DATA MANAGEMENT: PERIODIC SAFETY UPDATE REPORTS FOR MARKETED DRUGS (CPMP/ICH/288/95) [ICH Harmonised Tripartite Guideline]
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