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 ...
ICH E6 (R3) introduces a dedicated section on data governance, reflecting the increasing complexity of data sources and ...
The flexibility and incompatibility of ICH Q12 guidelines with current EU legislations raise complications. As the world’s economy is increasingly threatened by new barriers to trade, the ...
In anticipation of these new guidelines, TransCelerate assembled a team of experts to evaluate the guidance and develop tools to support adoption of ICH E6 (R3). The array of tools announced today ...
The new guidelines will address bioanalytical method validation and biopharmaceutics classification system-based biowaivers. On Oct. 19, 2016, the International Council for Harmonization (ICH) ...
The internationally harmonized guideline for a risk-based approach on assessing and controlling elemental impurities in drug products entered the final implementation phase. ICH Q3D(R1) Guideline for ...
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 ...
In minutes from their meeting in Singapore last November, the International Council for Harmonisation (ICH) Management Committee and Assembly provide updates on a range of issues not covered in ...
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