ICH E6 (R3) introduces a dedicated section on data governance, reflecting the increasing complexity of data sources and systems used in modern trials. Sponsors are expected to maintain oversight of ...
Experts have recommended ICH Q10 PQS (International Council for Harmonisation - Pharmaceutical Quality System) guidelines on pharma quality systems for effective implementation of revised Schedule M ...
The Agilent 2100 Bioanalyzer plus the Agilent High Sensitivity Protein 250 Kit automatically detects and quantifies protein impurities down to 0.05% ? meeting ICH guideline Q3B(R2)! The Agilent 2100 ...
The International Conference on Harmonisation’s (ICH) Good Clinical Practice (GCP) guideline (E6) is ripe for review, according to the vast majority of respondents to a members’ poll by the UK-based ...
Expert and implementation working groups harmonize more guidelines and move Q11 forward. The International Conference on Harmonization's (ICH) Expert Working Groups (EWGs) and Steering Committee met ...
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