{"id":383,"date":"2024-04-25T10:07:50","date_gmt":"2024-04-25T10:07:50","guid":{"rendered":"http:\/\/annualreport-2025.guerillainteractive.co.uk\/?page_id=383"},"modified":"2025-08-28T07:48:09","modified_gmt":"2025-08-28T07:48:09","slug":"reseau-europeen-des-laboratoires-officiels-de-controle-des-medicaments","status":"publish","type":"page","link":"https:\/\/annualreport-2025.guerillainteractive.co.uk\/fr\/reseau-europeen-des-laboratoires-officiels-de-controle-des-medicaments\/","title":{"rendered":"R\u00e9seau europ\u00e9en des laboratoires officiels de contr\u00f4le des m\u00e9dicaments"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"383\" class=\"elementor elementor-383\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-528c7fc elementor-section-height-min-height elementor-section-stretched elementor-section-boxed elementor-section-height-default elementor-section-items-middle elementor-invisible\" data-id=\"528c7fc\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;stretch_section&quot;:&quot;section-stretched&quot;,&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;fadeInDown&quot;}\" data-no-translation=\"\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-d1721d2\" data-id=\"d1721d2\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-a295144 elementor-widget elementor-widget-heading\" data-id=\"a295144\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Qualit\u00e9 et utilisation des m\u00e9dicaments<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-31d0ca1 elementor-section-stretched animated-slow elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"31d0ca1\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;stretch_section&quot;:&quot;section-stretched&quot;,&quot;animation&quot;:&quot;fadeIn&quot;}\" data-no-translation=\"\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-f0b72df\" data-id=\"f0b72df\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-a70d86c elementor-widget elementor-widget-heading\" data-id=\"a70d86c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">R\u00e9seau europ\u00e9en des laboratoires officiels de contr\u00f4le des m\u00e9dicaments<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-8801f7b elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"8801f7b\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-a2c3db1\" data-id=\"a2c3db1\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-9e9c336 elementor-widget elementor-widget-text-editor\" data-id=\"9e9c336\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Le r\u00e9seau europ\u00e9en des laboratoires officiels de contr\u00f4le des m\u00e9dicaments (OMCL) r\u00e9unit les laboratoires officiels de 35\u00a0\u00c9tats membres europ\u00e9ens et de sept pays non europ\u00e9ens, dans l\u2019objectif de prot\u00e9ger la sant\u00e9 publique en assurant l\u2019innocuit\u00e9 et la qualit\u00e9 des m\u00e9dicaments commercialis\u00e9s. Ensemble, ils \u00e9vitent que des m\u00e9dicaments de qualit\u00e9 non conforme ou falsifi\u00e9s ne parviennent pas aux personnes soign\u00e9es, et jouent ainsi un r\u00f4le essentiel dans la protection de la sant\u00e9 publique, en garantissant des traitements efficaces et sans danger. Le r\u00e9seau\u00a0OMCL s\u2019engage \u00e9galement \u00e0 faire respecter des normes strictes par le biais d\u2019\u00e9tudes de surveillance du march\u00e9 robustes et d\u2019initiatives de lutte contre la falsification.<\/p><p>Coordonn\u00e9 par l\u2019EDQM et cofinanc\u00e9 par l\u2019UE, le r\u00e9seau g\u00e9n\u00e9ral europ\u00e9en des OMCL (GEON) est un mod\u00e8le de collaboration. Acteur d\u00e9terminant de la protection de la sant\u00e9 publique, il facilite la communication et le partage de connaissances, harmonise les normes appliqu\u00e9es et les m\u00e9thodologies de contr\u00f4le utilis\u00e9es par ses membres et mutualise les ressources, \u0153uvrant ainsi \u00e0 d\u00e9velopper la confiance accord\u00e9e aux m\u00e9dicaments. En collaborant, les laboratoires renforcent leur capacit\u00e9 collective \u00e0 r\u00e9pondre rapidement et efficacement aux difficult\u00e9s, en fourn<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fc7bd98 elementor-widget elementor-widget-image\" data-id=\"fc7bd98\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"1636\" height=\"388\" src=\"https:\/\/annualreport-2025.guerillainteractive.co.uk\/wp-content\/uploads\/2024\/06\/Funded-EU-and-COE-Implemented-COE-quadri-fr.png\" class=\"attachment-full size-full wp-image-939\" alt=\"\" srcset=\"https:\/\/annualreport-2025.guerillainteractive.co.uk\/wp-content\/uploads\/2024\/06\/Funded-EU-and-COE-Implemented-COE-quadri-fr.png 1636w, https:\/\/annualreport-2025.guerillainteractive.co.uk\/wp-content\/uploads\/2024\/06\/Funded-EU-and-COE-Implemented-COE-quadri-fr-300x71.png 300w, https:\/\/annualreport-2025.guerillainteractive.co.uk\/wp-content\/uploads\/2024\/06\/Funded-EU-and-COE-Implemented-COE-quadri-fr-1024x243.png 1024w, https:\/\/annualreport-2025.guerillainteractive.co.uk\/wp-content\/uploads\/2024\/06\/Funded-EU-and-COE-Implemented-COE-quadri-fr-768x182.png 768w, https:\/\/annualreport-2025.guerillainteractive.co.uk\/wp-content\/uploads\/2024\/06\/Funded-EU-and-COE-Implemented-COE-quadri-fr-1536x364.png 1536w, https:\/\/annualreport-2025.guerillainteractive.co.uk\/wp-content\/uploads\/2024\/06\/Funded-EU-and-COE-Implemented-COE-quadri-fr-18x4.png 18w\" sizes=\"(max-width: 1636px) 100vw, 1636px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-2818fbe elementor-section-stretched animated-slow elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"2818fbe\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;stretch_section&quot;:&quot;section-stretched&quot;,&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;fadeIn&quot;}\" data-no-translation=\"\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-9f8c0d6\" data-id=\"9f8c0d6\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-f5042a8 elementor-widget elementor-widget-heading\" data-id=\"f5042a8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Management de la qualit\u00e9<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d2eab97 elementor-widget elementor-widget-heading\" data-id=\"d2eab97\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Programme de travail<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6fa9769 elementor-widget elementor-widget-text-editor\" data-id=\"6fa9769\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>Programme d\u2019audits mutuels conjoints(AMC)\/visites mutuelles conjointes (VMC) et de visites de formation (VF)<\/strong><\/p><p>L\u2019harmonisation des syst\u00e8mes de management de la qualit\u00e9 (SMQ) entre OMCL et l\u2019atteinte de niveaux de qualit\u00e9 appropri\u00e9s demeurent les objectifs principaux de l\u2019activit\u00e9 d\u2019audit. L\u2019id\u00e9e est de permettre la reconnaissance mutuelle des r\u00e9sultats exp\u00e9rimentaux entre membres, dans le cadre de programmes comme les essais de lib\u00e9ration officielle des lots de produits biologiques, la surveillance du march\u00e9 des m\u00e9dicaments autoris\u00e9s et le contr\u00f4le des m\u00e9dicaments falsifi\u00e9s.<\/p><p>En\u00a02024, le programme d\u2019audit a \u00e9t\u00e9 men\u00e9 principalement sous la forme d\u2019\u00e9valuations sur site de laboratoires, et a compris un audit r\u00e9alis\u00e9 \u00e0 distance.<\/p><p>Neuf AMC de r\u00e9\u00e9valuation compl\u00e8te et une VF ont \u00e9t\u00e9 r\u00e9alis\u00e9s. Depuis le lancement du programme de management de la qualit\u00e9 (MQ) pour les OMCL en\u00a01997, 248\u00a0AMC, 52\u00a0VMC et 29\u00a0VF\/tutoriels ont \u00e9t\u00e9 men\u00e9s.<\/p><p><strong>Formations\/ateliers<\/strong><\/p><p>En\u00a02024, l\u2019EDQM a organis\u00e9 deux ateliers\u00a0: le premier, en septembre, a permis aux auditeurs et auditrices du programme d\u2019AMC\/VMC de partager leurs exp\u00e9riences en mati\u00e8re d\u2019audit et le second, en octobre, a \u00e9t\u00e9 consacr\u00e9 \u00e0 la validation des syst\u00e8mes informatiques.<\/p><p><strong>Essais d\u2019aptitude<\/strong><\/p><p>Le programme d\u2019essais d\u2019aptitude (PTS) de l\u2019EDQM offre aux laboratoires un moyen objectif d\u2019\u00e9valuer et de d\u00e9montrer la fiabilit\u00e9 de leurs donn\u00e9es. En\u00a02024, cinq \u00e9tudes physicochimiques et cinq \u00e9tudes biologiques ont \u00e9t\u00e9 r\u00e9alis\u00e9es.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-9445745 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"9445745\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-d4fec65\" data-id=\"d4fec65\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-af078fd elementor-widget elementor-widget-heading\" data-id=\"af078fd\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Coop\u00e9ration internationale<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-13da74d elementor-widget elementor-widget-text-editor\" data-id=\"13da74d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>La phase\u00a011 de l\u2019EQAAS (syst\u00e8me d\u2019\u00e9valuation de l\u2019assurance qualit\u00e9), organis\u00e9e en collaboration avec l\u2019OMS, a \u00e9t\u00e9 cl\u00f4tur\u00e9e en\u00a02024.<\/p><p>L\u2019EDQM est une intervenante \u00e0 part enti\u00e8re (\u00ab\u00a0<em>recognised stakeholder\u00a0<\/em>\u00bb) de la Coop\u00e9ration europ\u00e9enne pour l\u2019accr\u00e9ditation (EA). Elle participe r\u00e9guli\u00e8rement aux r\u00e9unions du Comit\u00e9 du laboratoire de l\u2019EA (EA\/LC) afin de renforcer la collaboration avec ses membres et de clarifier les questions techniques d\u2019int\u00e9r\u00eat pour le r\u00e9seau\u00a0OMCL li\u00e9es \u00e0 l\u2019interpr\u00e9tation des exigences de la norme ISO\/CEI\u00a017025:2017.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-7ef52f8\" data-id=\"7ef52f8\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-cb67f54 elementor-widget elementor-widget-heading\" data-id=\"cb67f54\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Publications, bases de donn\u00e9es et site web<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ab2c203 elementor-widget elementor-widget-text-editor\" data-id=\"ab2c203\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Des <em>guidelines <\/em>communs en mati\u00e8re de MQ, visant \u00e0 aider les laboratoires \u00e0 se conformer aux exigences de la norme\u00a0ISO\/CEI\u00a017025:2017, sont r\u00e9dig\u00e9s par des expert\u00b7es du r\u00e9seau, et r\u00e9guli\u00e8rement mis \u00e0 jour, sous la coordination du Secr\u00e9tariat de l\u2019EDQM. En\u00a02024, deux <em>guidelines <\/em>ont \u00e9t\u00e9 publi\u00e9s\u00a0; cinq autres documents sont en cours de r\u00e9vision (voir <span style=\"color: #ffffff;\"><a style=\"color: #ffffff;\" href=\"#qm-table-fr\" rel=\"noopener\">Documents de management de la qualit\u00e9 \u00e9labor\u00e9s en\u00a02024<\/a>).<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-b8c93bc elementor-section-stretched animated-slow elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"b8c93bc\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;stretch_section&quot;:&quot;section-stretched&quot;,&quot;animation&quot;:&quot;fadeIn&quot;}\" data-no-translation=\"\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-eda3fae\" data-id=\"eda3fae\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-03158aa elementor-widget elementor-widget-heading\" data-id=\"03158aa\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Activit\u00e9s du GEON<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-afc7825 elementor-widget elementor-widget-heading\" data-id=\"afc7825\" data-element_type=\"widget\" data-e-type=\"widget\" data-no-translation=\"\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Accueil d\u2019un nouveau membre<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9e51954 elementor-widget elementor-widget-text-editor\" data-id=\"9e51954\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Le d\u00e9partement des laboratoires d\u2019analyse et de contr\u00f4le de l\u2019Agence turque des m\u00e9dicaments et dispositifs m\u00e9dicaux est devenu membre de plein droit du GEON en ao\u00fbt\u00a02024. La T\u00fcrkiye a adh\u00e9r\u00e9 \u00e0 la Convention relative \u00e0 l\u2019\u00e9laboration d\u2019une Pharmacop\u00e9e europ\u00e9enne en\u00a01993\u00a0; elle est donc repr\u00e9sent\u00e9e aupr\u00e8s de l\u2019EPC depuis lors. Elle a demand\u00e9 officiellement \u00e0 rejoindre le GEON en\u00a02022. Ce r\u00e9seau se r\u00e9jouit de coop\u00e9rer \u00e9troitement avec l\u2019OMCL turc dans le cadre de ses programmes et au sein de ses diff\u00e9rents groupes de travail. Il s\u2019agit l\u00e0 du r\u00e9sultat tangible des efforts strat\u00e9giques d\u00e9ploy\u00e9s par l\u2019EDQM pour \u00e9tendre sa port\u00e9e internationale afin de r\u00e9pondre plus efficacement aux probl\u00e9matiques sanitaires mondiales.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-02f1006 elementor-widget elementor-widget-heading\" data-id=\"02f1006\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Programme de travail<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-91e7e41 elementor-widget elementor-widget-text-editor\" data-id=\"91e7e41\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"color: #163a87;\"><strong>Assembl\u00e9e g\u00e9n\u00e9rale annuelle du GEON<\/strong><\/span><\/p><p>L\u2019assembl\u00e9e g\u00e9n\u00e9rale annuelle du GEON s\u2019est tenue du 13 au 17\u00a0mai\u00a02024, \u00e0 Ohrid (Mac\u00e9doine du Nord). Plus de 230\u00a0personnes de 38\u00a0\u00c9tats membres ont particip\u00e9 aux neuf sessions pr\u00e9sentielles propos\u00e9es. Marquant le 30<sup>e<\/sup> anniversaire du r\u00e9seau\u00a0OMCL, la r\u00e9union a \u00e9t\u00e9 l\u2019occasion de revenir sur l\u2019histoire du r\u00e9seau et d\u2019explorer les d\u00e9fis \u00e0 relever dans les ann\u00e9es \u00e0 venir.\u00a0Plusieurs volets de l\u2019objectif strat\u00e9gique de renforcement des capacit\u00e9s du GEON ont \u00e9t\u00e9 d\u00e9velopp\u00e9s lors des pr\u00e9sentations. Des questions relatives aux SMQ pr\u00e9sentant un int\u00e9r\u00eat particulier pour le r\u00e9seau ont \u00e9galement \u00e9t\u00e9 couvertes lors de l\u2019assembl\u00e9e g\u00e9n\u00e9rale. Pour la premi\u00e8re fois, le th\u00e8me de la chimie verte a \u00e9t\u00e9 abord\u00e9 et il a \u00e9t\u00e9 d\u00e9cid\u00e9 d\u2019\u00e9laborer une strat\u00e9gie en la mati\u00e8re pour le r\u00e9seau.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2862557 elementor-widget elementor-widget-text-editor\" data-id=\"2862557\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Visionnez la session consacr\u00e9e au 30<sup>e<\/sup>\u00a0anniversaire du r\u00e9seau\u00a0OMCL (en VO), qui s\u2019est tenue lors de la conf\u00e9rence du 60<sup>e<\/sup>\u00a0anniversaire de l\u2019EDQM, pour suivre un d\u00e9bat anim\u00e9 et informatif sur la mani\u00e8re dont le r\u00e9seau\u00a0OMCL assure le contr\u00f4le qualit\u00e9 des m\u00e9dicaments gr\u00e2ce \u00e0 la collaboration et \u00e0 la reconnaissance mutuelle des r\u00e9sultats exp\u00e9rimentaux. Pour les versions avec interpr\u00e9tation fran\u00e7aise, voir le site internet de l\u2019EDQM\u00a0: \u00ab\u00a0<a href=\"https:\/\/www.edqm.eu\/fr\/11-12-june-2024-celebrating-60-years-of-excellence-in-public-health-protection\" target=\"_blank\" rel=\"noopener\">Aujourd&#8217;hui comme demain, ensemble pour la sant\u00e9 publique<\/a>\u00a0\u00bb.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4bec49e elementor-widget elementor-widget-video\" data-id=\"4bec49e\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;video_type&quot;:&quot;vimeo&quot;}\" data-widget_type=\"video.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-wrapper elementor-open-inline\">\n\t\t\t<iframe class=\"elementor-video-iframe\" allowfullscreen allow=\"clipboard-write\" title=\"Lecteur vid\u00e9o vimeo\" src=\"https:\/\/player.vimeo.com\/video\/1095858845?color&amp;autopause=0&amp;loop=0&amp;muted=0&amp;title=1&amp;portrait=1&amp;byline=1#t=\"><\/iframe>\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-d627a96 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"d627a96\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-e92e2ce\" data-id=\"e92e2ce\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-2101963 elementor-widget elementor-widget-text-editor\" data-id=\"2101963\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>\u00c9tudes g\u00e9n\u00e9rales de surveillance du march\u00e9<\/strong><\/p><p>Lanc\u00e9e fin\u00a02023, la phase exp\u00e9rimentale de l\u2019\u00e9tude de surveillance du march\u00e9 sur la rosuvastatine (substance active et comprim\u00e9s) (MSS063) a \u00e9t\u00e9 men\u00e9e en\u00a02024. L\u2019\u00e9tude de surveillance du march\u00e9 portant sur les masques m\u00e9dicaux (MSS064) a \u00e9t\u00e9 cl\u00f4tur\u00e9e. Une nouvelle \u00e9tude a \u00e9t\u00e9 lanc\u00e9e sur les capsules \u00e0 enveloppe dure de pr\u00e9gabaline (MSS062).<\/p><p><strong>Groupe de Travail sur les substances actives (GT\u00a0API)<\/strong><\/p><p>La r\u00e9orientation de la port\u00e9e des activit\u00e9s du GT\u00a0API et des futures \u00e9tudes de surveillance du march\u00e9 <em>fingerprint<\/em> (MSSFP), amorc\u00e9e en\u00a02023, a \u00e9t\u00e9 confirm\u00e9e en\u00a02024 par la revue du document de synth\u00e8se correspondant \u00e9mis par le GT et de la proc\u00e9dure relative aux MSSFP.<\/p><p>En\u00a02024 a \u00e9t\u00e9 lanc\u00e9e l\u2019\u00e9tude\u00a0MSSFP006 sur le l\u00e9nalidomide, qui a mis l\u2019accent sur la surveillance de la qualit\u00e9 des substances actives, conform\u00e9ment au p\u00e9rim\u00e8tre d\u2019action r\u00e9vis\u00e9 du GT\u00a0API.<\/p><p><strong>Groupe de Travail\u00a0OMCL sur les m\u00e9dicaments falsifi\u00e9s<\/strong><\/p><p>Le rapport de la sixi\u00e8me \u00e9tude de surveillance du march\u00e9 sur des produits pr\u00e9sum\u00e9s ill\u00e9gaux (MSSIP) a \u00e9t\u00e9 publi\u00e9 en d\u00e9cembre\u00a02024. Cette \u00e9tude a port\u00e9 sur les modulateurs s\u00e9lectifs des r\u00e9cepteurs aux androg\u00e8nes (SARM), les modulateurs m\u00e9taboliques et les s\u00e9cr\u00e9tagogues de l\u2019hormone de croissance \u00e0 petites mol\u00e9cules utilis\u00e9s pour l\u2019am\u00e9lioration des performances sportives. L\u2019ibutamoren, l\u2019ostarine et la cardarine font partie des substances les plus fr\u00e9quemment d\u00e9tect\u00e9es.<\/p><p>Les r\u00e9sultats de la septi\u00e8me\u00a0MSSIP sur les nootropes ont \u00e9t\u00e9 collect\u00e9s en novembre\u00a02024. Parmi les substances les plus fr\u00e9quemment d\u00e9tect\u00e9es figurent la l\u00e9vodopa, l\u2019\u00e9ph\u00e9drine\/pseudo\u00e9ph\u00e9drine, ainsi que le modafinil et ses analogues. Le rapport final devrait \u00eatre publi\u00e9 en\u00a02025.<\/p><p>La huiti\u00e8me\u00a0MSSIP sur les antibiotiques provenant de sources ill\u00e9gales a \u00e9t\u00e9 lanc\u00e9e en f\u00e9vrier\u00a02024.<\/p><p>Le document \u00ab\u00a0Aide-Memoire\u00a0: Testing of Suspected Illegally Traded and Falsified Medicines\u00a0\u00bb destin\u00e9 aux OMCL a \u00e9t\u00e9 r\u00e9vis\u00e9, principalement pour y introduire un nouveau chapitre sur les dispositifs m\u00e9dicaux. Une version r\u00e9vis\u00e9e du document \u00ab\u00a0Aide-Memoire: How to identify a falsified monoclonal antibody\/antibody containing fusion protein\u00a0\u00bb a \u00e9galement \u00e9t\u00e9 publi\u00e9e.<\/p><p>Dans le cadre du programme de contr\u00f4le des produits inconnus suspects (SUP), une nouvelle \u00e9tude (SUP013) a \u00e9t\u00e9 amorc\u00e9e en\u00a02024. Impliquant 27\u00a0OMCL, elle vise \u00e0 identifier, en aveugle, la substance pr\u00e9sente dans un \u00e9chantillon.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-db5ad02\" data-id=\"db5ad02\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-3883638 elementor-widget elementor-widget-text-editor\" data-id=\"3883638\" data-element_type=\"widget\" data-e-type=\"widget\" data-no-translation=\"\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>Groupe de Travail\u00a0OMCL sur les m\u00e9dicaments de th\u00e9rapie g\u00e9nique (GTWG)<\/strong><\/p><p>Actuellement compos\u00e9 de 11\u00a0OMCL, le GTWG a tenu sa 14<sup>e<\/sup>\u00a0r\u00e9union (en ligne), en septembre. Parmi les sujets abord\u00e9s figurait le renforcement des capacit\u00e9s des OMCL en mati\u00e8re de contr\u00f4le des m\u00e9dicaments de th\u00e9rapie g\u00e9nique dans le but de soutenir la surveillance du march\u00e9 centralis\u00e9e, qui a \u00e9galement \u00e9t\u00e9 au c\u0153ur des discussions lors de la r\u00e9union annuelle des OMCL. Des progr\u00e8s ont \u00e9t\u00e9 r\u00e9alis\u00e9s en ce qui concerne la validation des m\u00e9thodes standardis\u00e9es relatives au contr\u00f4le qualit\u00e9 des vecteurs\u00a0AAV (virus ad\u00e9noassoci\u00e9s), avec notamment la publication des r\u00e9sultats d\u2019une \u00e9tude intitul\u00e9e \u00ab\u00a0<a href=\"https:\/\/pbiosn.edqm.eu\/app\/pbiosn\/content\/default\/2024-10_ELISA_method_for_AAV2-based_vectors_physical_particles_titre_determination.pdf\">Validation of an ELISA method for determination of physical particle titre of AAV2-based vector preparations<\/a>\u00a0\u00bb (d\u00e9tails ci-apr\u00e8s) et la mise en place de deux projets \u2013 l\u2019un sur le titre en g\u00e9nomes infectieux et l\u2019autre sur la d\u00e9termination du titre en particules physiques de vecteurs\u00a0AAV2\/8 par test immuno-enzymatique (ELISA, <em>enzyme-linked immunosorbent assay<\/em>).<\/p><p><strong>Nitrosamines \u2013 strat\u00e9gies d\u2019\u00e9chantillonnage et m\u00e9thodes d\u2019analyse<\/strong><\/p><p>Depuis\u00a0mi-2018, les membres du GEON participent \u00e0 diff\u00e9rentes activit\u00e9s relatives \u00e0 la d\u00e9tection des nitrosamines dans les substances actives et les m\u00e9dicaments. Un groupe\u00a0OMCL de contr\u00f4le \u00e9tabli \u00e0 ces fins s\u2019est r\u00e9uni 16\u00a0fois depuis lors et a \u00e9tendu son champ d\u2019activit\u00e9 au-del\u00e0 de la cat\u00e9gorie des nitrosamines (comprenant les impuret\u00e9s nitrosamine d\u00e9riv\u00e9es de la substance active) afin de couvrir \u00e9galement le dosage des impuret\u00e9s mutag\u00e8nes pr\u00e9sentes \u00e0 l\u2019\u00e9tat de traces (impuret\u00e9s azotur\u00e9es dans les sartans \u00e0 cycle t\u00e9trazole, par exemple).<\/p><p>Sur la base des enseignements tir\u00e9s des cas de contamination par des nitrosamines, un addendum au document interne du r\u00e9seau\u00a0OMCL intitul\u00e9 \u00ab\u00a0Incident management\u00a0\u00bb a \u00e9t\u00e9 publi\u00e9 en d\u00e9cembre\u00a02024. Il d\u00e9crit les points suppl\u00e9mentaires \u00e0 prendre en consid\u00e9ration en cas de crise, lorsque le nombre de ressources disponibles et\/ou d\u2019OMCL capables d\u2019effectuer les contr\u00f4les n\u00e9cessaires est limit\u00e9.<\/p><p>Une formation pratique portant sur le contr\u00f4le des nitrosamines, destin\u00e9e aux OMCL, a \u00e9t\u00e9 organis\u00e9e par l\u2019OMCL suisse (Swissmedic), \u00e0 Berne, en juin\u00a02024. Dans le cadre du programme de coop\u00e9ration avec l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) au sujet de l\u2019\u00e9chantillonnage et du contr\u00f4le des produits autoris\u00e9s selon la proc\u00e9dure centralis\u00e9e (CAP), un programme d\u2019essai sp\u00e9cialement consacr\u00e9 aux nitrosamines a \u00e9t\u00e9 mis en place et sera men\u00e9 \u00e0 compter de janvier\u00a02025.<\/p><p>Ces initiatives sont d\u00e9taill\u00e9es sur la <a href=\"https:\/\/www.edqm.eu\/fr\/n-nitrosamine-contamination-in-brief\">page web de l\u2019EDQM consacr\u00e9e aux nitrosamines<\/a>.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<div class=\"elementor-element elementor-element-fc6a283 elementor-widget elementor-widget-heading\" data-id=\"fc6a283\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Coop\u00e9ration internationale<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e9efa25 elementor-widget elementor-widget-text-editor\" data-id=\"e9efa25\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>L\u2019EDQM a facilit\u00e9 les \u00e9changes entre l\u2019Organisation mondiale de la sant\u00e9 animale (OMSA) et le r\u00e9seau\u00a0OMCL pour la mise en place de projets de collaboration dans le domaine de la lutte contre les m\u00e9dicaments de qualit\u00e9 non conforme ou falsifi\u00e9s. En outre, des discussions ont \u00e9t\u00e9 men\u00e9es avec l\u2019OMS afin d\u2019\u00e9tablir des liens entre la base de donn\u00e9es du GSMS (syst\u00e8me mondial de surveillance et de suivi de l\u2019OMS pour les produits m\u00e9dicaux de qualit\u00e9 inf\u00e9rieure et falsifi\u00e9s) \u2013 en cours de d\u00e9veloppement \u2013 et la base de donn\u00e9es\u00a0Know-X de l\u2019EDQM.<\/p><p>Des repr\u00e9sentant\u00b7es de l\u2019EDQM ont particip\u00e9 \u00e0 plusieurs r\u00e9unions et formations organis\u00e9es par l\u2019OMS, par l\u2019EMA et par l\u2019Agence de d\u00e9veloppement de l\u2019Union africaine\u00a0\u2013 Nouveau partenariat pour le d\u00e9veloppement de l\u2019Afrique (AUDA-NEPAD), avec le soutien de divers partenaires internationaux, en vue de promouvoir le renforcement des capacit\u00e9s des OMCL africains.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2e35327 elementor-widget elementor-widget-heading\" data-id=\"2e35327\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Publications, bases de donn\u00e9es et site web<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d689de2 elementor-widget elementor-widget-text-editor\" data-id=\"d689de2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>En\u00a02024, quatre nouveaux documents g\u00e9n\u00e9raux du r\u00e9seau\u00a0OMCL ont \u00e9t\u00e9 achev\u00e9s et cinq autres r\u00e9vis\u00e9s.<\/p><p>Le GTWG a publi\u00e9 un article intitul\u00e9 \u00ab\u00a0Validation of an ELISA method for determination of physical particle titre of AAV2-based vector preparations\u00a0\u00bb dans <em>Pharmeuropa Bio &amp; Scientific Notes<\/em> (voir <a href=\"https:\/\/annualreport-2025.guerillainteractive.co.uk\/fr\/bibliographie\/\" data-wplink-edit=\"true\"><em>Bibliographie<\/em><\/a><em>\u00a0<\/em>).<\/p><p><strong>CombiStats<\/strong><\/p><p>CombiStats est un outil de r\u00e9f\u00e9rence reconnu pour l\u2019analyse statistique des r\u00e9sultats de titrages biologiques, qui contribue \u00e0 la reconnaissance mutuelle des donn\u00e9es et des r\u00e9sultats par l\u2019ensemble des parties int\u00e9ress\u00e9es. Une version en ligne a remplac\u00e9 l\u2019application de bureau en octobre\u00a02024. Accessible par une connexion individuelle et s\u00e9curis\u00e9e (e-mail et mot de passe), CombiStats offre d\u00e9sormais une interface utilisateur moderne, des espaces de travail sp\u00e9cifiques, un large choix de mod\u00e8les statistiques et d\u2019autres nouveaut\u00e9s, notamment une piste d\u2019audit. Un syst\u00e8me de gestion des licences plus flexible a \u00e9galement \u00e9t\u00e9 introduit. D\u00e9but d\u00e9cembre\u00a02024, pr\u00e8s de 800\u00a0licences avaient \u00e9t\u00e9 vendues pour l\u2019application en ligne. CombiStats est utilis\u00e9 dans plus de 60\u00a0pays, dont la moiti\u00e9 environ en Europe.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-e2b9463 elementor-section-stretched animated-slow elementor-section-boxed elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"e2b9463\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;stretch_section&quot;:&quot;section-stretched&quot;,&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;fadeIn&quot;}\" data-no-translation=\"\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-85c46e6\" data-id=\"85c46e6\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-066b66c elementor-widget elementor-widget-heading\" data-id=\"066b66c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Activit\u00e9s concernant sp\u00e9cifiquement les pays de l\u2019UE\/EEE<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-302c6d6 elementor-widget elementor-widget-heading\" data-id=\"302c6d6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Programme de travail<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7ba8e69 elementor-widget elementor-widget-text-editor\" data-id=\"7ba8e69\" data-element_type=\"widget\" data-e-type=\"widget\" data-no-translation=\"\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<style>.elementor-element-7ba8e69{display:none !important}<\/style>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-c7af24c elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"c7af24c\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-0578e0c\" data-id=\"0578e0c\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-7a19257 elementor-widget elementor-widget-image\" data-id=\"7a19257\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"486\" height=\"583\" src=\"https:\/\/annualreport-2025.guerillainteractive.co.uk\/wp-content\/uploads\/2024\/06\/Icon-06-OMCLs-Biologicals.png\" class=\"attachment-full size-full wp-image-785\" alt=\"\" srcset=\"https:\/\/annualreport-2025.guerillainteractive.co.uk\/wp-content\/uploads\/2024\/06\/Icon-06-OMCLs-Biologicals.png 486w, https:\/\/annualreport-2025.guerillainteractive.co.uk\/wp-content\/uploads\/2024\/06\/Icon-06-OMCLs-Biologicals-250x300.png 250w\" sizes=\"(max-width: 486px) 100vw, 486px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9f974bc elementor-widget elementor-widget-counter\" data-id=\"9f974bc\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"counter.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-counter\">\n\t\t\t<div class=\"elementor-counter-title\">lots finaux de vaccins pour usage humain et de m\u00e9dicaments d\u00e9riv\u00e9s du sang humain \u00e9valu\u00e9s<\/div>\t\t\t<div class=\"elementor-counter-number-wrapper\">\n\t\t\t\t<span class=\"elementor-counter-number-prefix\"><\/span>\n\t\t\t\t<span class=\"elementor-counter-number\" data-duration=\"2000\" data-to-value=\"12598\" data-from-value=\"0\" data-delimiter=\" \">0<\/span>\n\t\t\t\t<span class=\"elementor-counter-number-suffix\"><\/span>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-874f10c\" data-id=\"874f10c\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-2463da7 elementor-widget elementor-widget-image\" data-id=\"2463da7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"486\" height=\"583\" src=\"https:\/\/annualreport-2025.guerillainteractive.co.uk\/wp-content\/uploads\/2024\/06\/Icon-07-OMCLs-Biologicals.png\" class=\"attachment-full size-full wp-image-786\" alt=\"\" srcset=\"https:\/\/annualreport-2025.guerillainteractive.co.uk\/wp-content\/uploads\/2024\/06\/Icon-07-OMCLs-Biologicals.png 486w, https:\/\/annualreport-2025.guerillainteractive.co.uk\/wp-content\/uploads\/2024\/06\/Icon-07-OMCLs-Biologicals-250x300.png 250w\" sizes=\"(max-width: 486px) 100vw, 486px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-339ba92 elementor-widget elementor-widget-counter\" data-id=\"339ba92\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"counter.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-counter\">\n\t\t\t<div class=\"elementor-counter-title\">m\u00e9langes de plasma soumis \u00e0 des contr\u00f4les d\u2019innocuit\u00e9<\/div>\t\t\t<div class=\"elementor-counter-number-wrapper\">\n\t\t\t\t<span class=\"elementor-counter-number-prefix\"><\/span>\n\t\t\t\t<span class=\"elementor-counter-number\" data-duration=\"2000\" data-to-value=\"13860\" data-from-value=\"0\" data-delimiter=\" \">0<\/span>\n\t\t\t\t<span class=\"elementor-counter-number-suffix\"><\/span>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<div class=\"elementor-element elementor-element-50e0588 elementor-widget elementor-widget-text-editor\" data-id=\"50e0588\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>L\u2019assembl\u00e9e annuelle du r\u00e9seau\u00a0OCABR pour les produits biologiques \u00e0 usage humain a principalement port\u00e9 sur les produits du sang, les vaccins et les probl\u00e8mes communs. Elle a facilit\u00e9 le partage d\u2019expertise, l\u2019optimisation des ressources et la mise au point de strat\u00e9gies visant \u00e0 encourager l\u2019approche collective.<\/p><p>En\u00a02024, deux postes ont \u00e9t\u00e9 pourvus (par \u00e9lection) au sein du Comit\u00e9 consultatif\u00a0OCABR, qui comprend d\u00e9sormais trois repr\u00e9sentant\u00b7es du secteur du sang (Pays-Bas, Espagne et Allemagne) et trois du secteur des vaccins (Belgique, Autriche et France).<\/p><p>En\u00a02024, les OMCL ont \u00e9valu\u00e9 quelque 12\u00a0600\u00a0lots finaux de vaccins pour usage humain et de m\u00e9dicaments d\u00e9riv\u00e9s du sang humain et ont contr\u00f4l\u00e9 l\u2019innocuit\u00e9 d\u2019environ 14\u00a0000\u00a0m\u00e9langes de plasma. Ces activit\u00e9s permettent de confirmer, de mani\u00e8re ind\u00e9pendante, que la qualit\u00e9 de ces produits r\u00e9pond aux crit\u00e8res \u00e9tablis avant qu\u2019ils ne parviennent aux personnes auxquelles ils seront administr\u00e9s. Environ 135\u00a0lots de vaccins contre le COVID-19 ont \u00e9t\u00e9 lib\u00e9r\u00e9s en\u00a02024, contre plus de\u00a0320 et 1\u00a0700\u00a0lots, respectivement, en\u00a02023 et 2022. Ces chiffres refl\u00e8tent la fin de l\u2019\u00e9tat d\u2019urgence sanitaire mondiale li\u00e9 au COVID-19. Malgr\u00e9 une baisse de la demande en vaccins contre le COVID-19, le nombre total de lots de vaccins \u00e9valu\u00e9s a augment\u00e9 par rapport \u00e0\u00a02023. Cette \u00e9volution est la cons\u00e9quence logique de l\u2019introduction sur le march\u00e9 europ\u00e9en de nouveaux vaccins, notamment deux vaccins contre le virus respiratoire syncytial (VRS) et un contre le virus du chikungunya, ainsi que d\u2019une croissance de la demande en vaccins du voyage, notamment contre la fi\u00e8vre jaune, la fi\u00e8vre typho\u00efde, l\u2019enc\u00e9phalite japonaise et l\u2019enc\u00e9phalite \u00e0 tiques. La quantit\u00e9 de vaccins en cours de d\u00e9veloppement ne cessant de cro\u00eetre, les OMCL travaillent continuellement \u00e0 l\u2019\u00e9laboration et \u00e0 la r\u00e9vision de nombreux documents de recommandation et mettent en \u0153uvre de nouvelles m\u00e9thodes en pr\u00e9paration de la lib\u00e9ration des lots.<\/p><p>\u00c0 plusieurs reprises, la collaboration entre OMCL et la pr\u00e9sence d\u2019un OMCL rempla\u00e7ant se sont av\u00e9r\u00e9es essentielles \u00e0 la r\u00e9silience et la fiabilit\u00e9 du syst\u00e8me de lib\u00e9ration des lots. Par exemple, dans le domaine du sang, des efforts de coop\u00e9ration ont permis d\u2019\u00e9valuer et de r\u00e9soudre des probl\u00e8mes techniques constat\u00e9s lors du d\u00e9pistage des anticorps anti-VIH dans certains m\u00e9langes de plasma. Au vu de la hausse de la demande de capacit\u00e9s de contr\u00f4le, une nouvelle strat\u00e9gie d\u2019optimisation du contr\u00f4le des vaccins \u00e0 prot\u00e9ine recombinante, amorc\u00e9e en\u00a02023, a contribu\u00e9 \u00e0 une meilleure utilisation des ressources.<\/p><p>En\u00a02024, en vertu du principe des\u00a03R, les OMCL ont r\u00e9affirm\u00e9 leur engagement \u00e0 r\u00e9duire, raffiner et remplacer l\u2019utilisation des animaux dans les essais n\u00e9cessaires \u00e0 la lib\u00e9ration des lots. Ils ont continu\u00e9 \u00e0 recueillir des donn\u00e9es et \u00e0 \u00e9tablir des rapports sur l\u2019utilisation des animaux dans le cadre de la proc\u00e9dure\u00a0OCABR, exercice qui avait d\u00e9but\u00e9 en\u00a02022. D\u2019apr\u00e8s les donn\u00e9es fournies par les OMCL, il appara\u00eet que l\u2019exp\u00e9rimentation animale a diminu\u00e9 de\u00a02019 \u00e0\u00a02022. Le r\u00e9seau a d\u00e9cid\u00e9 de poursuivre l\u2019exercice en\u00a02025. Une r\u00e9flexion men\u00e9e sur le tableau de d\u00e9claration de l\u2019utilisation d\u2019animaux a suscit\u00e9 une r\u00e9vision du <em>guideline\u00a0<\/em>OCABR sur les m\u00e9canismes visant \u00e0 r\u00e9duire les essais <em>in\u00a0vivo<\/em> appliqu\u00e9s par les OMCL aux fins de la proc\u00e9dure\u00a0OCABR.<\/p><p>Plusieurs OMCL ont fait part de leur intention de mettre en \u0153uvre des m\u00e9thodes <em>in\u00a0vitro<\/em> pour les essais de d\u00e9tection des antig\u00e8nes dipht\u00e9rie (D), t\u00e9tanos (T) et coqueluche acellulaire (Ca). En juillet\u00a02024, l\u2019EDQM a organis\u00e9 une r\u00e9union virtuelle qui a permis aux OMCL int\u00e9ress\u00e9s de partager des informations et de pr\u00e9parer le terrain pour une \u00e9ventuelle future harmonisation de leurs strat\u00e9gies.<\/p><p>Compte tenu de la suppression de l\u2019essai des pyrog\u00e8nes sur lapin de la Ph.\u00a0Eur., les OMCL se pr\u00e9parent \u00e0 mettre en \u0153uvre l\u2019essai d\u2019activation des monocytes d\u00e8s que n\u00e9cessaire, ainsi qu\u2019\u00e0 r\u00e9viser les <em>guidelines<\/em> sp\u00e9cifiques aux produits. Des efforts ont \u00e9galement \u00e9t\u00e9 entrepris pour remplacer l\u2019essai \u00e0 base de lysat d\u2019am\u0153bocyte de limule (LAL) par la m\u00e9thode du facteur\u00a0C recombinant (rFC) dans le cadre de la d\u00e9tection des endotoxines bact\u00e9riennes.<\/p><p>Les OMCL connaissent une augmentation de leurs activit\u00e9s de lib\u00e9ration des lots. Ainsi, des OMCL novices en la mati\u00e8re se sont joints \u00e0 l\u2019effort. En outre, de nouveaux titulaires d\u2019autorisation de mise sur le march\u00e9 (AMM) ou fabricants sont entr\u00e9s en sc\u00e8ne. En r\u00e9ponse \u00e0 ces \u00e9volutions, un nouveau <em>guideline <\/em>g\u00e9n\u00e9ral visant \u00e0 promouvoir une approche commune des interactions entre OMCL et fabricants ou titulaires d\u2019AMM a \u00e9t\u00e9 adopt\u00e9 en mai. Il a rencontr\u00e9 un accueil favorable. Il a donc \u00e9t\u00e9 propos\u00e9 d\u2019en \u00e9laborer une version qui pourrait \u00eatre diffus\u00e9e aupr\u00e8s des fabricants.<\/p><p><strong>Lib\u00e9ration des lots de m\u00e9dicaments immunologiques v\u00e9t\u00e9rinaires<\/strong><\/p><p>Le Veterinary Batch Release Network (VBRN) \u2013 r\u00e9seau charg\u00e9 de la lib\u00e9ration des lots de m\u00e9dicaments v\u00e9t\u00e9rinaires \u2013 est un important forum d\u2019\u00e9changes confidentiels d\u2019informations relatives \u00e0 la qualit\u00e9 et de donn\u00e9es techniques sur les m\u00e9dicaments immunologiques v\u00e9t\u00e9rinaires (MIV) et les m\u00e9thodes connexes. Maillon cl\u00e9 de la cha\u00eene r\u00e9glementaire, il favorise la reconnaissance mutuelle obligatoire de la proc\u00e9dure\u00a0OCABR des MIV, et a permis l\u2019adoption d\u2019un accord de volont\u00e9 qui permet la reconnaissance mutuelle des certificats\u00a0OBPR (\u00e9valuation officielle des protocoles de contr\u00f4le des lots) entre \u00c9tats membres, sous r\u00e9serve du respect de la proc\u00e9dure et des r\u00e8gles codifi\u00e9es par le r\u00e9seau.<\/p><p>Il est supervis\u00e9 par un comit\u00e9 consultatif \u00e9lu, compos\u00e9 de quatre repr\u00e9sentant\u00b7es de diff\u00e9rents \u00c9tats membres, actuellement l\u2019Allemagne, la Belgique, la Pologne et la R\u00e9publique slovaque. Une r\u00e9union pl\u00e9ni\u00e8re est organis\u00e9e chaque ann\u00e9e. Le Comit\u00e9 consultatif du VBRN a tenu deux r\u00e9unions en\u00a02024 afin d\u2019avancer sur des questions importantes et de pr\u00e9parer l\u2019assembl\u00e9e annuelle, qui s\u2019est d\u00e9roul\u00e9e en mai.<\/p><p>Il a \u00e9labor\u00e9 un nouveau <em>guideline <\/em>pour aider les OMCL et les Autorit\u00e9s comp\u00e9tentes \u00e0 d\u00e9velopper une plateforme \u00e9lectronique, sur la base de l\u2019exp\u00e9rience d\u2019un OMCL et en s\u2019appuyant sur les retours et l\u2019exp\u00e9rience d\u2019autres membres du r\u00e9seau. Le recours \u00e0 des mod\u00e8les communs afin de mieux coordonner les activit\u00e9s de surveillance apr\u00e8s commercialisation des produits s\u2019est poursuivi\u00a0; six OMCL ont communiqu\u00e9 des donn\u00e9es en\u00a02024 au sujet de futurs plans et des activit\u00e9s de\u00a02023. Lors de sa r\u00e9union annuelle, le r\u00e9seau en a profit\u00e9 pour r\u00e9fl\u00e9chir \u00e0 la mani\u00e8re dont les OMCL pourraient utiliser au mieux les informations collect\u00e9es, et le Comit\u00e9 consultatif proposera une r\u00e9vision de la strat\u00e9gie actuelle \u00e0 cette fin.<\/p><p>Une strat\u00e9gie de contr\u00f4le \u00e0 court terme avait \u00e9t\u00e9 amorc\u00e9e en\u00a02023 pour r\u00e9pondre \u00e0 un probl\u00e8me de qualit\u00e9 concernant un vaccin rabique vivant pour administration orale. Elle s\u2019est poursuivie en\u00a02024 et a \u00e9t\u00e9 \u00e9tendue \u00e0 un autre produit du m\u00eame fabricant suivant un proc\u00e9d\u00e9 de fabrication similaire. Les OMCL qui ont particip\u00e9 au contr\u00f4le de ces produits ont interagi avec succ\u00e8s avec leurs Autorit\u00e9s comp\u00e9tentes et le proc\u00e9d\u00e9 de fabrication a \u00e9t\u00e9 pass\u00e9 en revue, ce qui a entra\u00een\u00e9 des modifications de l\u2019AMM. Les OMCL concern\u00e9s suivent de pr\u00e8s la question et feront un compte-rendu lors de la prochaine r\u00e9union annuelle.<\/p><p>Les OMCL impliqu\u00e9s dans la lib\u00e9ration des lots de MIV ont \u00e9galement contribu\u00e9 aux efforts en mati\u00e8re de 3R. Un OMCL a indiqu\u00e9 avoir mis en application, avec succ\u00e8s, un essai d\u2019activit\u00e9 <em>in\u00a0vitro <\/em>pour le vaccin antirabique inactiv\u00e9 pour usage v\u00e9t\u00e9rinaire. D\u2019autres se sont d\u00e9clar\u00e9s pr\u00eats \u00e0 \u00e9changer des proc\u00e9dures op\u00e9ratoires standardis\u00e9es afin de renforcer le cumul des capacit\u00e9s et des comp\u00e9tences en mati\u00e8re d\u2019essais <em>in\u00a0vitro<\/em> appliqu\u00e9s \u00e0 ces vaccins, ainsi qu\u2019\u00e0 r\u00e9fl\u00e9chir \u00e0 la possibilit\u00e9 de mettre au point une m\u00e9thode commune.<\/p><p>Au mois de mars, le Comit\u00e9 consultatif du VBRN a rencontr\u00e9 des repr\u00e9sentant\u00b7es de fabricants de MIV. Cette r\u00e9union productive a donn\u00e9 lieu \u00e0 des \u00e9changes ouverts et \u00e0 des rappels de bonnes pratiques\u00a0; les enseignements tir\u00e9s de la crise de COVID-19 ont \u00e9t\u00e9 pass\u00e9s en revue\u00a0; des points ont \u00e9t\u00e9 faits sur les derni\u00e8res \u00e9volutions et les plans de mise en \u0153uvre des strat\u00e9gies\u00a03R ont \u00e9t\u00e9 examin\u00e9s.<\/p><p>Une formation sur l\u2019OBPR des MIV, destin\u00e9e aux n\u00e9ophytes, s\u2019est d\u00e9roul\u00e9e en ligne en octobre. Suivie par 35\u00a0personnes de 14\u00a0pays, elle a \u00e9t\u00e9 couronn\u00e9e de succ\u00e8s.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-2a03189 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"2a03189\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-e6813f3\" data-id=\"e6813f3\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-e540c85 elementor-widget elementor-widget-heading\" data-id=\"e540c85\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Coop\u00e9ration internationale<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6dd688d elementor-widget elementor-widget-text-editor\" data-id=\"6dd688d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Le r\u00e9seau\u00a0OCABR pour les produits biologiques \u00e0 usage humain a poursuivi sa coop\u00e9ration mondiale par le biais des protocoles d\u2019entente conclus avec les autorit\u00e9s d\u2019Australie, du Canada, d\u2019Isra\u00ebl et du Royaume-Uni, ainsi qu\u2019avec la Taiwan Food and Drug Administration (TFDA). L\u2019EDQM et les membres du r\u00e9seau\u00a0OCABR de l\u2019UE ont \u00e9galement contribu\u00e9 aux activit\u00e9s du R\u00e9seau\u00a0OMS-Laboratoires nationaux de contr\u00f4le pour les produits biologiques pr\u00e9qualifi\u00e9s par l\u2019OMS.<\/p><p>Le VBRN a \u00e9galement poursuivi sa coop\u00e9ration avec le Royaume-Uni par le biais d\u2019un protocole d\u2019entente.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-66c4d5d\" data-id=\"66c4d5d\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-aac9894 elementor-widget elementor-widget-heading\" data-id=\"aac9894\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Publications, bases de donn\u00e9es et site web<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0e63a78 elementor-widget elementor-widget-text-editor\" data-id=\"0e63a78\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Fin\u00a02024, la base de donn\u00e9es regroupant les \u00e9tudes\u00a0PRM\/PDC (cr\u00e9\u00e9e en\u00a02007 dans le but de renforcer la coop\u00e9ration relative aux activit\u00e9s de planification, d\u2019\u00e9chantillonnage et de communication des r\u00e9sultats concernant les produits\u00a0PRM\/PDC men\u00e9es au sein du r\u00e9seau\u00a0OMCL) comptait plus de 19\u00a0000 enregistrements, auxquels avaient contribu\u00e9 37\u00a0OMCL. L\u2019acc\u00e8s \u00e0 cette base de donn\u00e9es est r\u00e9serv\u00e9 aux OMCL et aux Autorit\u00e9s de sant\u00e9.<\/p><p>Depuis mars\u00a02020, des mod\u00e8les d\u2019\u00e9valuation des risques contenant \u00e9galement des recommandations relatives au contr\u00f4le des produits\u00a0PRM\/PDC sont r\u00e9guli\u00e8rement transf\u00e9r\u00e9s dans cette base de donn\u00e9es, qui en comptait environ 3\u00a0300 fin\u00a02024.<\/p><p>Deux nouveaux <em>guidelines <\/em>et sept <em>guidelines <\/em>r\u00e9vis\u00e9s concernant la lib\u00e9ration des lots de vaccins pour usage humain ont \u00e9t\u00e9 publi\u00e9s. En outre, la proc\u00e9dure administrative de l\u2019UE relative \u00e0 l\u2019OCABR a \u00e9t\u00e9 r\u00e9vis\u00e9e pour y inclure une nouvelle annexe (annexe\u00a0IIh).<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-a645c52 elementor-section-stretched elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"a645c52\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;stretch_section&quot;:&quot;section-stretched&quot;}\" data-no-translation=\"\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-7273a9b elementor-invisible\" data-id=\"7273a9b\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;animation&quot;:&quot;fadeInLeft&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-67c51f6 elementor-widget elementor-widget-button\" data-id=\"67c51f6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/annualreport-2025.guerillainteractive.co.uk\/fr\/certification-de-conformite\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-left\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M257.5 445.1l-22.2 22.2c-9.4 9.4-24.6 9.4-33.9 0L7 273c-9.4-9.4-9.4-24.6 0-33.9L201.4 44.7c9.4-9.4 24.6-9.4 33.9 0l22.2 22.2c9.5 9.5 9.3 25-.4 34.3L136.6 216H424c13.3 0 24 10.7 24 24v32c0 13.3-10.7 24-24 24H136.6l120.5 114.8c9.8 9.3 10 24.8.4 34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Page pr\u00e9c\u00e9dente<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-c3e287a elementor-invisible\" data-id=\"c3e287a\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;animation&quot;:&quot;fadeInRight&quot;,&quot;animation_mobile&quot;:&quot;fadeInLeft&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-8465c24 elementor-align-right elementor-mobile-align-left elementor-widget elementor-widget-button\" data-id=\"8465c24\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/annualreport-2025.guerillainteractive.co.uk\/fr\/activites-antifalsification\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-right\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Page suivante<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Quality &amp; use of medicines Qualit\u00e9 et utilisation des m\u00e9dicaments The European Network of Official Medicines Control Laboratories The OMCL Network brings together official laboratories from 35 European member states and seven non-European countries to protect public health by ensuring the quality and safety of medicines on the market. 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