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Certification of suitability (CEP) | News | 27 October 2021 | Strasbourg, France
Would you like to build a career in regulatory affairs? Do you have excellent chemical synthesis or analytical chemistry skills? Do you have the scientific expertise required to check the acceptability of applications for Certification of Suitability to the monographs of the European Pharmacopoeia (CEP) on receipt, to critically review data according to ICH, EU and EDQM guidelines, to prepare...
Certification of suitability (CEP) | News | 20 October 2021 | Strasbourg, France
Holders of Certificates of suitability to the monographs of the European Pharmacopoeia (CEPs) are requested to consult the list of substances for which draft revised monographs of the European Pharmacopoeia (Ph. Eur.) have been published in Pharmeuropa 33.4. The table below lists the substances affected by these revisions and for which a CEP has been granted.
Certification of suitability (CEP) | News | 19 October 2021 | Strasbourg, France
Supplement 10.7 of the European Pharmacopoeia (Ph. Eur.) is now available. Holders of Certificates of suitability to the monographs of the Ph. Eur. (CEPs) are invited to update their applications according to the revised monographs that will be implemented on 1 April 2022, and to follow the instructions given below.
European Pharmacopoeia / International harmonisation | News | 18 October 2021 | Strasbourg, France
The Pharmacopoeial Discussion Group (PDG), which brings together the European Pharmacopoeia (Ph. Eur.), the Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP), with the World Health Organization (WHO) as an observer, is preparing a pilot to integrate additional world pharmacopoeias. This is a critical step in the PDG’s commitment to expanding recognition of harmonised...
European Pharmacopoeia / General | News | 15 October 2021 | Strasbourg, France
The European Directorate for the Quality of Medicines & HealthCare (EDQM) will discontinue the device version of the European Pharmacopoeia (Ph. Eur.) as of the 11th Edition, which is scheduled for publication in July 2022, and focus efforts on the online and paper versions.
European Pharmacopoeia / Monograph | News | 14 October 2021 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) is seeking stakeholder feedback on the revised general chapter on Osmolality (2.2.35), published in this quarter’s issue of Pharmeuropa (33.4) for comment (deadline 31 December 2021).
Transfusion | News | 14 October 2021 | Strasbourg, France
The supply of blood components involves a series of complex processes composed of numerous steps, each carrying intrinsic and extrinsic risks. Blood establishments must continuously adapt to new regulatory and technical requirements in quality management as part of their risk avoidance strategy. In this evolving context, quality risk management can play a pivotal role in meeting these...
News | 13 October 2021 | Strasbourg, France
Do you have experience in chemical hazard classification and/or Safety Data Sheet (SDS) requirements? Are you detail-oriented and able to work under pressure and meet deadlines? Do you have the excellent written and oral communication skills required to gather and provide technical information to users? If so, our job offer may be the right opportunity for you.
Transplantation / European Organ Donation Day (EODD) | News | 09 October 2021 | Strasbourg, France
This year, celebrations for the European Day for Organ Donation and Transplantation (EODD) will take place online on Saturday, 9 October. EODD is an opportunity to discuss organ, tissue and cell donation and transplantation and reflect upon their importance, as well as to thank donors, their families and all the health professionals involved.
Reference Standard / Collection & Catalogue | News | 08 October 2021 | Strasbourg, France
The European Directorate for the Quality of Medicines & HealthCare (EDQM) announces the availability of 4 new European Pharmacopoeia (Ph. Eur.) reference standards and 21 replacement batches for Ph. Eur. reference standards.
News | 08 October 2021 | Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
Paediatric Formulary | News | 07 October 2021 | Strasbourg, France
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has added a new monograph, Phosphate 60 mg/mL Oral Solution, to the European Paediatric Formulary. Elaborated by a dedicated European Pharmacopoeia (Ph. Eur.) working party, the monograph was initially published in Issue 3 of Pharmeuropa PaedForm, then approved by the Ph. Eur. Commission and adopted by the European...
European Pharmacopoeia / Monograph | News | 06 October 2021 | Strasbourg, France
A new draft monograph, Oxygen (98 per cent) (3098), has been published for comment in this quarter’s issue of Pharmeuropa (33.4), the European Pharmacopoeia (Ph. Eur.) online forum. The deadline for comments on the new monograph is 31 December 2021.
European Pharmacopoeia / Public enquiry | News | 05 October 2021 | Strasbourg, France
All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 33.4 is 31 December 2021.
Transfusion / General | News | 05 October 2021 | Strasbourg, France
Main responsibilities of the job: As a Scientific Programme Manager, you will help draft guides and develop guidelines and/or co-ordinate and promote co-operation activities to improve quality, safety and ethical standards for the collection, storage and distribution of blood and blood components by European Blood Establishments (for example, EDQM Blood Guide, the Blood Quality Management...