ICH E6 (R3) introduces a dedicated section on data governance, reflecting the increasing complexity of data sources and ...
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 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 ...
Analytical characterization is vital for product quality, manufacturing control, and regulatory compliance in biopharmaceutical development. ICH Q6B outlines structural characterization requirements, ...
The ICH Q12 guideline aims to harmonize post-approval change management, addressing delays and supply issues in the pharmaceutical industry. Global adoption is limited, with only three ICH countries ...
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