Transcription of CLINICAL SAFETY DATA MANAGEMENT …
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CLINICAL SAFETY DATA MANAGEMENT …
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE CLINICAL SAFETY DATA MANAGEMENT : DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING E2A Current Step 4 version dated 27 October 1994 This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA. E2A Document History First Codification History Date New Codification November 2005 E2A Approval by the Steering Committee under Step 2 and release for public consultation.
Clinical Safety Data Management The following definitions, with input from the WHO Collaborative Centre, have been agreed: 1. Adverse Event (or Adverse Experience)
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Medicines Control Council, Reporting, Adverse drug reactions, MEDICINES CONTROL COUNCIL REPORTING ADVERSE DRUG REACTIONS, Pharmacovigilance guidelines, ADVERSE DRUG, GUIDELINES FOR MONITORING AND REPORTING, GUIDELINES FOR MONITORING AND REPORTING ADVERSE DRUG REACTIONS, Adverse Drug Reaction Reporting, ADVERSE DRUG REACTION-CAUSALITY, ADVERSE DRUG REACTION-CAUSALITY ASSESSMENT, SAFETY MONITORING