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Transplantation / Donation Campaigns & European Organ Donation Day (EODD) | News | 09 May 2018 | Strasbourg, France
To improve the situation and change the perception of donation and transplantation continent-wide, the EDQM is launching a communication campaign on its social media, which will run throughout the summer until the European Organ Donation Day (EODD) celebration in October.
Certification of suitability (CEP) / Inspection | News | 24 April 2018 | Strasbourg, France
As part of the Certification of Suitability procedure, the EDQM runs an inspection programme for API manufacturers and is committed to optimise the inspection resources as much as possible.
Transplantation / Organ | News | 23 April 2018 | Strasbourg, France
The Committee on Organ Transplantation (CD-P-TO) has issued a recommendation not to engage in Global Kidney Exchange (GKE) programmes and to support instead the development of fair and equitable kidney paired exchange programmes.
Products and Services | News | 17 April 2018 | Strasbourg, France
The 2019 subscriptions are now available for sale on our webstore. Don’t delay, order your subscription now!
European Pharmacopoeia / Ph. Eur. Commission | News | 17 April 2018 | Strasbourg, France
The Ph. Eur. Commission decided at its 160th session of March 2018 to reactivate its dedicated GTP Working Party. Experts from both Ph. Eur. and non Ph. Eur. member states are welcome to participate in this work.
European Pharmacopoeia / Ph. Eur. Commission | News | 16 April 2018 | Strasbourg, France
The European Pharmacopoeia Commission achieved an important milestone on quality requirements for Live Biotherapeutic Products (LBPs) for human use with the adoption of quality standards.
European Pharmacopoeia / General text/chapter | News | 13 April 2018 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) Commission launches a public consultation on its proposal to replace the Histamine Sensitisation Test (HIST) for residual pertussis toxin testing.
European network of OMCLs / Human Biologicals (OCABR) / Vaccines | News | 09 April 2018 | Strasbourg, France
OCABR guidelines for vaccines with acellular Pertussis (aP) components have been revised to remove an animal test used for OCABR.
European network of OMCLs / General European OMCLs Network activities | News | 09 April 2018 | Strasbourg, France
GEON quality management document: The guideline “Validation of Computerised Systems” has been revised
European Pharmacopoeia / Ph. Eur. Commission | News | 06 April 2018 | Strasbourg, France
At its 160th session the Ph. Eur. Commission adopted a new version of one of its major general methods, which has undergone extensive revision. The chapter on Infrared Absorption Spectrophotometry (2.2.24) is one of the original cornerstones of pharmacopoeial testing, referenced in many general texts and more than 1200 individual monographs.
European Pharmacopoeia / Ph. Eur. Commission | News | 05 April 2018 | Strasbourg, France
At its latest Session, the European Pharmacopoeia Commission adopted 19 new monographs, 3 new chapters, 51 revised monographs and 15 revised chapters.
European Pharmacopoeia / Monograph | News | 03 April 2018 | Strasbourg, France
Due to the public health risk associated with histamine contamination, further requirements related to the quality of raw materials have been added to the Raw materials section of the monograph on Products of fermentation (1468).
Products and Services | News | 03 April 2018 | Strasbourg, France
4 new Ph. Eur. Reference Standards (RS) were released in March 2018
European Pharmacopoeia / Monograph | News | 03 April 2018 | Strasbourg, France
Due to the public health risk associated with histamine contamination, further requirements related to the quality of raw materials have been added to the Raw materials section of the monograph on Products of fermentation (1468).
Products and Services | News | 03 April 2018 | Strasbourg, France
Pharmeuropa contains draft pharmacopoeial texts for which the European Pharmacopoeia Commission is seeking comment.