This Blog is created for the updation of knowledge on Quality Assurance, current Good Manufacturing Practices (cGMP) and current Updates from all regulatory authorities. Also one can archive Standard Operating Procedures (SOPs), specification and pharma jobs etc. for any Pharma plant.
Monday, December 6, 2010
E2D: Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting
The Guideline was finalised, underStep 4of the ICH process, on November 12, 2003. This document provides a standardized procedure for post-approval safety data management including expedited reporting to relevant authority. The definitions of the terms and concept specific to post-approval phase are also provided. E2A definitions in clinical safety data management was maintained in this document as post-approval safety data management, such as seriousness definition. The practices of the data management were standardized in such cases obtained from consumers, literatures, internets which are all specific to post-approval data management. Good case management practice was focused and recommended for expedited reporting with clear definitions.