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Fra 1. september 2025 vil Lægemiddelstyrelsen anmode om at modtage bioækvivalensdata i CDISC-format
From September 1, 2025 the Danish Medicines Agency will request submission of bioequivalence data in CDISC format Based on a pilot study conducted by the Danish Medicines Agency during 2023 an
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GCP inspection updates
Please note that the GCP inspection has updated information provided on the website. The updates vary in scope, but texts have been adapted to Regulation (EU) no 536/2014 and Guideline ICH E6 R3
