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European Directorate Quality Medicine
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Trending Articles
Rentschler Biopharma appoints Patrick Cushing as VP Operations for US subsidiary
The novel position will require Dr Cushing to manager operations at the Miford, MA facility in the US
Making the most of each cell: single-use perfusion in biopharma processing
GEA kytero perfusion disk stack separators are pioneering the time- and cost-efficient harvesting of pharmaceutical proteins from cells and facilitating continuous processing,...
Johnson & Johnson submits regulatory application for Tremfya to the European Medicines Agency
The submission included data from the Phase 3 QUASAR programme in ulcerative colitis and the Phase 3 GALAXI programme in Crohn’s disease, which each achieved their primary...
Amolyt receives FDA fast track designation for hypoparathyroidism drug
The therapeutic has been awarded the fast track designation owing to the Phase III Calypso trial, which showed promising efficacy and safety features
Indian government bans three medicines owing to health risks
Decision follows strong stand on suspending marketing of all drugs prohibited for sale in other countries, including the US, UK, EU and Australia
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European Pharmacopoeia (Ph. Eur.) Commission adopts new monographs and makes a number of revisions
They will come into effect in July 2017
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OMCL Network meets higher demand for independent experimental testing through enhanced work-sharing and collaboration
Most of the MRP/DCP products tested in 2015 were generic drugs
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European Pharmacopoeia: Tackling Future Challenges of the Quality of Medicines Together
27 - 28 September 2016, Conference, Tallinn, Estonia
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EDQM launches Know-X database
A user-friendly tool for regulators working to reduce counterfeit medical products
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EDQM publishes guidance on strategy to counter medicrime
Says aligned and close co-operation among authorities and stakeholders is key to fighting counterfeiting and similar crimes
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