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Online training | Online
The training will focus on chemically defined substances and cover all the fundamentals related to the use of the European Pharmacopoeia and its reference standards, as well as the procedure for Certification of suitability to the monographs of the European Pharmacopoeia (CEP).
European Pharmacopoeia | Online | 14 December 2021 | Strasbourg, France
The presence of foreign particles in liquid parenteral preparations (injections or infusions) represents a clinical risk to the patient and is therefore to be controlled and minimised. The general monograph Parenteral preparations (0520) has recently been revised to take into account current practices in the field, and provide requirements and recommendations for testing. The webinar will present the major changes made to the general monograph (published in Supplement 10.5 of the Ph. Eur.), in particular where the testing and evaluation of particulate contamination is concerned. It will also provide an insight into the draft general monograph on Monoclonal antibodies for human use (2031) (currently published in Pharmeuropa 33.4) that has been revised to bring it in line with Parenteral preparations (0520) with regard to visible particles. The term “practically free”, used in both texts, will be explained and recommendations given on how to interpret and implement it.
European Pharmacopoeia | Conference | 19 September 2022 to 21 September 2022 | online
After almost two years of online events, the European Directorate for the Quality of Medicines & HealthCare (EDQM) is eager to announce the organisation of an international conference to celebrate the publication of the 11th Edition of the European Pharmacopoeia (Ph. Eur.). This in-person event will be held from 19 to 21 September 2022, in Strasbourg (France), if the pandemic situation allows it.