Transcription of ADDENDUM TO ICH E2C* CLINICAL SAFETY DATA …
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ADDENDUM TO ICH E2C* CLINICAL SAFETY DATA …
The European Agency for the Evaluation of Medicinal Products ICH - Technical Coordination, EMEA 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 2003 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged London, 20 February 2003 CPMP/ICH/4679/02 ADDENDUM TO ICH E2C* CLINICAL SAFETY data management PERIODIC SAFETY UPDATE REPORTS FOR MARKETED DRUGS ICH Step 5 ADDENDUM TO ICH E2C (CPMP/ICH/288/95) TRANSMISSION TO CPMP September 2002 TRANSMISSION TO INTERESTED PARTIES September 2002 DEADLINE FOR COMMENTS December 2002 FINAL APPROVAL OF ADDENDUM BY CPMP February 2003 DATE FOR COMING INTO OPERATION August 2003 * previously designated as ICH Topic V1 2 EMEA 2003 ADDENDUM to ICH E2C CLINICAL SAFETY data management Periodic SAFETY Update Reports for Marketed Drugs Introduction This ADDENDUM is intended to provide practical guidance for the preparation of the Periodic SAFETY Update Report (PSUR) as recommended in the ICH Guideline E2C, CLINICAL SAFETY data management : Periodic SAFETY Update Reports for Marketed Drugs, which
CLINICAL SAFETY DATA MANAGEMENT PERIODIC SAFETY UPDATE REPORTS FOR MARKETED DRUGS ICH Step 5 ... ADDENDUM to ICH E2C Clinical Safety Data Management
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