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European Directorate Quality Medicine
European Directorate Quality Medicine
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Catalent and AstraZeneca to expand support for COVID-19 vaccine AZD1222
Catalent will prepare the Harmans facility, close to Baltimore-Washington International (BWI) airport, to enable multiple production trains to run in parallel to produce the...
Chemistry, manufacturing and control (CMC) as key drivers for drug discovery success
Embracing collaborative strategies not only accelerates drug development programmes but also fosters science-based milestone decisions, mitigates risks and prepares for...
LUNA 3: Rilzabrutinib Phase III immune thrombocytopenia trial meets primary endpoint
Rilzabrutinib met both the primary endpoint of durable platelet response and various secondary endpoints in patients who were refractory to prior therapy
Memel Biotech and Therabest collaborate to develop exosome-based cell therapies
The partnership will aim to develop, manufacture and distribute novel exosome cell therapies in a range of therapeutic areas
Ipsen and Skyhawk Therapeutics partner to develop RNA-targeting drug candidates
The USD $1.8bn deal will support the development of novel RNA-modulating drugs using Skyhawk's proprietary technology
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Europe releases 10th Pharmacopoeia edition with 114 new monographs
Thoroughly revised general chapters include infrared absorption spectrophotometry and Ultraviolet & visible absorption spectrophotometry
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Maintaining high quality standards in a dynamic global environment
Dr Susanne Keitel, Director of the EDQM, explains how the Ph. Eur. continues to meet the challenges of today’s global environment
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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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