Titre:edqm - european directorate for the quality of medicines |
La description :council for europe portal language : en search choose language english français www.coe.int human rights democracy rule of law en choose language english français search bouton d'ouverture du menu hom...
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Ce rapport est mis à jour en 03-Aug-2018
Created Date:
1997-08-20
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council for europe portal language : en search choose language english français www.coe.int human rights democracy rule of law en choose language english français search bouton d'ouverture du menu home about us about us management systems quality safety environment find information on memoranda of understanding and agreements quality management (qm) documents iso 9001 certificate iso 17025 edqm newsletter faq & helpdesk what's new? all news all events about edqm vision, mission & values history structure employment call for tenders contact us press enquiries contact details how to visit the edqm european pharmacopoeia european pharmacopoeia the ph. eur. work programme elaborations & revisions where to find: the knowledge database the ph. eur. work programme pharmacopoeial harmonisation international harmonisation what's new? latest news events find information on have a question about ph. eur. texts? technical guides how to order ph. eur. 9th edition ph. eur. 9th edition publication schedule ph. eur. online (subscriber access) pharmeuropa online pharmeuropa bio & sn online standard terms online combistats ph. eur. training resources the european pharmacopoeia (ph. eur.) background & mission membership & observership the european pharmacopoeia commission groups of experts and working parties european pharmacopoeia 9th edition how to participate in the work of the ph. eur. join the network! submitting drafts and requests for revision comment on drafts (pharmeuropa) biological standardisation programme (bsp) bsp work programme participate in a bsp study background & mission the steering committee focus new! biotherapeutics alternatives to animal testing (3rs) reference standards reference standards who rs who isa purpose & use who isa orders & catalogue who icrs purpose & use who icrs orders & catalogue find information on participate in an isa study (pdf) ph. eur. standard order form who isa standard order form who icrs standard order form faq & helpdesk rs reference standards training resources what's new? latest news events ph. eur. rs ph. eur. rs purpose & use ph. eur. rs orders & catalogue certification of suitability certification of suitability how to apply? new applications revisions and renewals technical advice & one-to-one meetings find information on certification policy documents & guidelines certification database actions on ceps knowledge database certificate of suitability (prices / orders) faq & helpdesk certification of suitability training resources what's new? latest news events about the procedure background & legal framework mission & organisation the inspection programme omcl network omcl network working group activities testing of apis testing of counterfeit/illegal medicines within the geon quality monitoring of stockpiled medicines gene therapy find information on quality management (qm) documents human ocabr guidelines veterinary ocabr guidelines combistats faq & helpdesk what's new? latest news events general activities background & mission of the geon quality management (qm) programme physico-chemical & biological pts market surveillance studies (mss) programmes eu/eea network mrp/dcp post marketing surveillance scheme cap sampling & testing programme human biologicals (ocabr) veterinary biologicals (ocabr/obpr) transfusion & transplantation transfusion & transplantation blood transfusion background & mission organisation & work programme recommendations & resolutions blood guide good practice guidelines for blood establishments projects reports blood proficiency testing scheme (b-pts) blood quality management programme (b-qm) find information on blood guide online organ guide online tissues and cells guide online faq & helpdesk what's new? latest news events european day for organ donation and transplantation (eodd) transplantation background & mission organisation & work programme legal framework reports & publications areas of work organs, tissues and cells technical guides patient & consumer health protection patient & consumer health protection pharmaceutical care background and mission work programme classification of medicines as regards their supply quality & safety standards in pharmaceutical care surveys and reports european paediatric formulary background & mission what's new? latest news events find information on medicrime convention map melclass database consumer health protection guides cosmetics and food contact guides online (existing clients) faq & helpdesk falsified medical products background & mission cd-p-ph/cmed work programme cd-p-ph/cmed the medicrime convention single points of contact (spoc) network falsified medical products & similar crimes publications testing of falsified medical products within the geon consumer health protection activities & latest developments cosmetics testing – occl food contact materials home twitter facebook googleplus pinterest linkedin email ph. eur. supplement 9.6: cep holders are invited to update their applications certification of suitability (cep) / procedure of certification (general) news 20 july 2018 strasbourg, france supplement 9.6 of the ph. eur is now available. cep holders are invited to update their applications according to the revised monographs that will be implemented on 1 january 2019, and to follow the instructions given in the document. twitter facebook googleplus pinterest linkedin email cep document revised: “implementation of ich q3d in the certification procedure” certification of suitability (cep) / procedure of certification (general) guideline 17 july 2018 strasbourg, france the edqm document “implementation of ich q3d in the certification procedure” has been revised based on experience gained by edqm since the initial implementation of the policy. its implementation date is the 1st september 2018. twitter facebook googleplus pinterest linkedin email pharmeuropa issue 30.3 is complete. comments before 30 september 2018 european pharmacopoeia / monograph news 17 july 2018 strasbourg, france pharmeuropa contains draft pharmacopoeial texts for which the european pharmacopoeia commission is seeking comment. if you would like to receive e-mail alerts when an issue is complete, please register for pharmeuropa online. pharmeuropa issue 30.3 is now complete. deadline for... 1 2 3 previous pause next see all news more news twitter facebook googleplus pinterest linkedin email edqm’s actions to evaluate impact of impurity in active substance... the edqm is aware of a quality defect related to an impurity in the active substance valsartan used in medicines to treat high blood pressure marketed in europe. twitter facebook googleplus pinterest linkedin email falsification of medical products: a revised version of know-x... this project will favour better interaction between the analytical and enforcement actors involved in the fight against falsified medicines and medical devices. twitter facebook googleplus pinterest linkedin email new monograph on sulfobutylbetadex sodium (2804) the new monograph on sulfobutylbetadex sodium (2804) was published in supplement 9.6 of the european pharmacopoeia. see all news agenda 18 september 2018 strasbourg, france workshop ‘what’s new in the field of excipients in china?’ 26 september 2018 strasbourg, france free webinar - ‘the newly revised edqm guideline on requi... 09 october 2018 to 11 october 2018 madrid, spain cphi worldwide 2018 see all events see reference standards catalogue ph. eur. 9th edition presentation reference standards & publication store free publications and databases certification of suitability (cep) news have a question? faq & helpdesk https://www.edqm.eu/en/news/all the vision of the edqm in brief twitter facebook googleplus pinterest linkedin email a directorate of the council of europe created in 1964. a leading organisation t
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