The EDQM will hold an international conference on 19-20 September 2017 in Prague (Czech Republic) to trace recent changes to the Certification Procedure in a fast moving regulatory environment.
With the publication of Supplement 9.3 of the European Pharmacopoeia, the USB version will be replaced by a downloadable version.
The EDQM will hold an international symposium on 10-11 October 2017 in Strasbourg (France) to present and discuss recent achievements, as well as future perspectives, of the Ph. Eur. in the microbiology field.
The Council of Europe’s EDQM has participated last week in the Summit on Organ Trafficking and Transplant Tourism organised by the Pontifical Academy of Sciences of the Vatican State to raise awareness on organ trafficking and human trafficking for the purpose of organ removal.
During a seminar coorganised with the European Medicines Agency (EMA), the EDQM clarified further the role that Ph. Eur. monographs play in the assessment of biosimilars.
The document PA/PH/CEP (13) 110 which described the policy for assessment of CEP applications has been revised following a review of current practice.
The last monthly activity report for the Certification of Substances Division (DCEP) is now available.
The application forms for the submission of new Certificate of Suitability applications and for requests for revision or renewal have been slightly revised...
With the implementation of the ICH Q3D guideline on elemental impurities, the control of elemental impurities is undergoing a shift in paradigm, moving away from pure substance-based testing towards a holistic control strategy in the finished product.
The EDQM is pleased to announce that the 2016 issue of Pharmeuropa Bio & Scientific Notes is available online
The Ph. Eur. Commission unanimously decided to grant Japan observer status. This brings to 30 the number of observers, from 6 continents.
The chapter on Chemical Imaging (5.24) was adopted by the European Pharmacopoeia Commission at the end of November 2016.
Pharmeuropa contains draft pharmacopoeial texts for which the European Pharmacopoeia Commission is seeking comment.
The EDQM is proud to announce that its Quality Management System has been recognised compliant to the 2015 version of the ISO 9001 standard.
Webinar on Elemental Impurities 17 January 2017: registration is closed as the maximum number of participants has been reached.