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International Conference On Harmonization
Latest Headlines
Latest Headlines
ICH hits milestone: Q11 draft posted for comments
Those who have come to believe that "Johnson & Johnson" and "quality" are mutually exclusive terms may be surprised to learn that the healthcare giant's director for quality and compliance
FDA outlines next steps to ensure safe products
Growth in imports of FDA-regulated products and the complexity of the global supply chain are the impetus for some strategic thinking at the FDA. The agency shared this thinking in a report issued
Turn to ICH for risk tools
There are many ways to do risk assessment, says Elaine Morefield of the FDA during this week's ISPE conference. Failure mode and effects analysis (FMEA) and fishbone diagrams are among them. "Q9 of
Dublin hosts stability center
Swiss pharma Helsinn has completed a 24-cubic-meter stability center at its Dublin facility. Stability chambers will operate at conditions dictated by the International Conference on Harmonization of
