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Transplantation / Publications | News | 05 July 2021 | Strasbourg, France
Personal choices regarding parenthood can be affected by disease and other life events that might have an impact on a person’s fertility. Making informed decisions in this highly personal area is of great importance to the health and well-being of individuals everywhere. The European Directorate for the Quality of Medicines & HealthCare (EDQM) has therefore  released a booklet entitled “...
Certification of suitability (CEP) / Inspection | News | 02 July 2021 | Strasbourg, France
Interruptions to the inspection programme of the European Directorate for the Quality of Medicines & HealthCare (EDQM) due to travel restrictions  – made necessary by the COVID-19 pandemic – led to the creation of a system of Real-Time Remote Inspections (RTEMIS).
European Pharmacopoeia / Ph. Eur. Commission | News | 02 July 2021 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) Commission held its 170th session on 22 and 23 June 2021. As the decision-making body of the Ph. Eur., the Commission adopted 69 texts that will be published in Ph. Eur. Supplement 10.8 and be effective as of 1 July 2022.
European Pharmacopoeia / Animal testing | News | 29 June 2021 | Strasbourg, France
The outcome of Part 2 of the BSP130 collaborative study run under the common aegis of the European Partnership for Alternative Approaches to Animal Testing (EPAA) and the European Directorate for the Quality of Medicines & HealthCare (EDQM) Biological Standardisation Programme (BSP) has just been published in Pharmeuropa Bio & Scientific Notes.
European Pharmacopoeia / Animal testing | News | 28 June 2021 | Strasbourg, France
At its 170th session in June 2021, the European Pharmacopoeia (Ph. Eur.) Commission took the decision to engage on a path that should ultimately lead to the complete replacement of the rabbit pyrogen test (RPT) in the Ph. Eur., within approximately 5 years.
EDQM / All activities | News | 28 June 2021 | Strasbourg, France
The Council of Europe has appointed Petra Dörr, PhD, as future Director of the European Directorate for the Quality of Medicines & HealthCare (EDQM). She will take over the function from the current Director, Susanne Keitel, in October 2021.
News | 27 June 2021 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) Supplement 10.6 is now available and will be applicable in 39 European countries as of 1 January 2022.
European Pharmacopoeia / International harmonisation | News | 24 June 2021 | Strasbourg, France
At its November 2020 meeting, the ICH Assembly approved the proposal made by the PDG (Pharmacopoeial Discussion Group) on how to include the pharmacopoeias of the non-Founding ICH Regulatory Members in the maintenance of the ICH Q4B Annexes. The expansion of ICH membership provides an excellent opportunity to further promote the global convergence of pharmacopoeial quality standards, through the...
Reference Standard / Reference spectra | News | 22 June 2021 | Strasbourg, France
Please be advised that as of July 2021, EDQM reference spectra will be sent exclusively by email in PDF format and no longer in paper format by courier.
Reference Standard / General | News | 17 June 2021 | Strasbourg, France
Are you enthusiastic about manufacturing operations? Are you able to spot and act on opportunities for optimisation to ensure that our objectives, in terms of the availability and quality of reference standards, are met? Do you have what it takes to manage a team of manufacturing technicians and operators from a wide variety of backgrounds? If so, this vacancy may be the right opportunity for you.
EDQM / All activities | News | 15 June 2021 | Strasbourg, France
On 26 May 2021, the European Directorate for the Quality of Medicines & HealthCare (EDQM) and the Eurasian Economic Commission (EEC) signed a memorandum of understanding.
Transfusion / Donations Campaigns & World Blood Donor Day (WBDD) | News | 14 June 2021 | Strasbourg, France
At every moment, someone, somewhere, needs blood. Blood components – plasma, red cells and platelets – are routinely used to save patients’ lives during surgery, after an accident or during acute illnesses, such as cancer or haemophilia. Regular blood donations are needed to give patients access to safe and quality-assured blood and blood components.
European Pharmacopoeia / Biological standardisation programme (BSP) | News | 11 June 2021 | Strasbourg, France
An article on the successful outcome of a recent study of the Biological Standardisation Programme (BSP) of the European Directorate for the Quality of Medicines & HealthCare (EDQM) has been published in Pharmeuropa Bio & Scientific Notes, the EDQM’s free online journal.
Certification of suitability (CEP) / Procedure of certification (general) | News | 08 June 2021 | Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
European Pharmacopoeia / Announcements | News | 07 June 2021 | Strasbourg, France
This virtual training will focus on chemically defined substances and cover all the fundamentals related to the use of the European Pharmacopoeia (Ph. Eur.) and its reference standards, as well as the procedure for Certification of suitability to the monographs of the European Pharmacopoeia (CEP).