{"id":2981,"date":"2022-05-05T15:00:17","date_gmt":"2022-05-05T13:00:17","guid":{"rendered":"https:\/\/3bbiotech.com\/pharmacovigilance\/"},"modified":"2025-03-24T11:49:13","modified_gmt":"2025-03-24T10:49:13","slug":"pharmacovigilance","status":"publish","type":"page","link":"https:\/\/3bbiotech.com\/fr\/pharmacovigilance\/","title":{"rendered":"Pharmacovigilance"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"2981\" class=\"elementor elementor-2981 elementor-1839\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-209740f elementor-section-stretched intro-page elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"209740f\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;stretch_section&quot;:&quot;section-stretched&quot;}\">\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-4a5cff5\" data-id=\"4a5cff5\" 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<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-592fd4e elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"592fd4e\" 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-16769fe animated-slow elementor-invisible\" data-id=\"16769fe\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&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-5eea623 elementor-widget elementor-widget-shortcode\" data-id=\"5eea623\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"shortcode.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-shortcode\"><span><span><a href=\"https:\/\/3bbiotech.com\/fr\/\">Home<\/a><\/span><\/span><\/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-25ffdcd animated-slow elementor-invisible\" data-id=\"25ffdcd\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;,&quot;animation_delay&quot;:500}\">\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-f49dd49 elementor-widget elementor-widget-heading\" data-id=\"f49dd49\" 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\">PHARMACOVIGILANCE ET S\u00c9CURIT\u00c9 CLINIQUE  <\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ba324c9 elementor-widget elementor-widget-heading\" data-id=\"ba324c9\" 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\">3B Biotech propose une gamme de services de pharmacovigilance locaux et mondiaux de haute qualit\u00e9. Gr\u00e2ce \u00e0 notre soci\u00e9t\u00e9 s\u0153ur GB Pharma, nous fournissons des solutions efficaces, comprenant le r\u00f4le de EU-QPPV, pour maintenir \u00e9galement votre syst\u00e8me de PV en Europe <\/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<div class=\"elementor-element elementor-element-0b87740 animated-slow elementor-invisible elementor-widget elementor-widget-image\" data-id=\"0b87740\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeIn&quot;,&quot;_animation_delay&quot;:800}\" 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=\"1920\" height=\"650\" src=\"https:\/\/3bbiotech.com\/wp-content\/uploads\/2022\/05\/pharmacovigilance-head-def.jpg\" class=\"attachment-full size-full wp-image-2982\" alt=\"\" srcset=\"https:\/\/3bbiotech.com\/wp-content\/uploads\/2022\/05\/pharmacovigilance-head-def.jpg 1920w, https:\/\/3bbiotech.com\/wp-content\/uploads\/2022\/05\/pharmacovigilance-head-def-300x102.jpg 300w, https:\/\/3bbiotech.com\/wp-content\/uploads\/2022\/05\/pharmacovigilance-head-def-1024x347.jpg 1024w, https:\/\/3bbiotech.com\/wp-content\/uploads\/2022\/05\/pharmacovigilance-head-def-768x260.jpg 768w, https:\/\/3bbiotech.com\/wp-content\/uploads\/2022\/05\/pharmacovigilance-head-def-1536x520.jpg 1536w\" sizes=\"(max-width: 1920px) 100vw, 1920px\" \/>\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<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-f9a566b elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"f9a566b\" 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-a8b282c\" data-id=\"a8b282c\" 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-46e3a82 elementor-widget elementor-widget-heading\" data-id=\"46e3a82\" 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\">Un ensemble complet et personnalis\u00e9 de services de pharmacovigilance locaux et mondiaux pour assurer la s\u00e9curit\u00e9 des patients \u00e0 toutes les \u00e9tapes du cycle de vie du produit, du stade du d\u00e9veloppement clinique pr\u00e9coce au support produit commercialis\u00e9. <\/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-inner-section elementor-element elementor-element-7498524 elementor-section-full_width bg-color elementor-section-height-default elementor-section-height-default\" data-id=\"7498524\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\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-0d6ef40 animated-slow elementor-invisible\" data-id=\"0d6ef40\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;,&quot;animation_delay&quot;:500}\">\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-6c4fb82 elementor-widget elementor-widget-heading\" data-id=\"6c4fb82\" 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\">Services de pharmacovigilance<\/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-inner-section elementor-element elementor-element-0a43a67 elementor-section-full_width animated-slow elementor-section-content-middle elementor-section-height-default elementor-section-height-default elementor-invisible\" data-id=\"0a43a67\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;fadeInUp&quot;}\">\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-a1b0b6a\" data-id=\"a1b0b6a\" 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-702aafb elementor-widget elementor-widget-accordion\" data-id=\"702aafb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-accordion\">\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1171\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-1171\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">SYST\u00c8ME DE GESTION QPPV ET PV <\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-1171\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-1171\"><p><strong>Avec un ensemble de proc\u00e9dures et un personnel de pharmacovigilance qualifi\u00e9, nous assurons la r\u00e9alisation des fonctions cl\u00e9s de PV, y compris le r\u00f4le de QPPV au nom de votre organisation pour suivre ces t\u00e2ches\u00a0: <\/strong><\/p><p>Gestion du syst\u00e8me de PV \u2013 Point de contact principal pour Cas, EMA et inspection (disponibilit\u00e9 24h\/24, 7j\/7) \u2013 Supervision du profil de s\u00e9curit\u00e9 de votre portefeuille \u2013 \u00c9valuation de la balance b\u00e9n\u00e9fice-risque \u2013 Examen et approbation de PASS \u2013 Gestion des mesures de minimisation des risques<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1172\" class=\"elementor-tab-title\" data-tab=\"2\" role=\"button\" aria-controls=\"elementor-tab-content-1172\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">GESTION DES RISQUES <\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-1172\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"2\" role=\"region\" aria-labelledby=\"elementor-tab-title-1172\"><p>Nos experts en gestion des risques peuvent vous assister dans l\u2019\u00e9laboration, la r\u00e9vision et la soumission d\u2019un plan de gestion des risques (PGR) classifiant les risques importants, identifi\u00e9s et potentiels. Par ailleurs, nous aidons nos clients \u00e0 \u00e9tablir des mesures de gestion des risques (RMM) appropri\u00e9s pour maximiser l\u2019utilisation de vos produits et augmenter la s\u00e9curit\u00e9 de vos produits.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1173\" class=\"elementor-tab-title\" data-tab=\"3\" role=\"button\" aria-controls=\"elementor-tab-content-1173\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">GESTION D\u2019EUDRAVIGILANCE <\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-1173\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"3\" role=\"region\" aria-labelledby=\"elementor-tab-title-1173\"><p>3B Biotech s\u2019occupe de tous les aspects de l\u2019enregistrement et de la maintenance d\u2019EudraVigilance, en mettant \u00e0 votre disposition des utilisateurs qualifi\u00e9s et form\u00e9s pour g\u00e9rer tous les modules int\u00e9gr\u00e9s dans la base de donn\u00e9es europ\u00e9enne.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1174\" class=\"elementor-tab-title\" data-tab=\"4\" role=\"button\" aria-controls=\"elementor-tab-content-1174\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">RAPPORTS DE SYNTH\u00c8SE <\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-1174\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"4\" role=\"region\" aria-labelledby=\"elementor-tab-title-1174\"><p>Des rapports p\u00e9riodiques actualis\u00e9s de s\u00e9curit\u00e9 (PSUR) \u00e0 la d\u00e9tection de signaux, en passant par les plans de gestion des risques (PRG), notre service comprend la planification, l\u2019\u00e9laboration, la r\u00e9vision et la soumission de rapports de synth\u00e8se. Nos techniciens qualifi\u00e9s et nos experts m\u00e9dicaux assurent un aper\u00e7u continu de la balance b\u00e9n\u00e9fice\/risque ainsi que de l\u2019efficacit\u00e9 et de la s\u00e9curit\u00e9 des produits.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1175\" class=\"elementor-tab-title\" data-tab=\"5\" role=\"button\" aria-controls=\"elementor-tab-content-1175\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">S\u00c9LECTION DE LA LITT\u00c9RATURE <\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-1175\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"5\" role=\"region\" aria-labelledby=\"elementor-tab-title-1175\"><p>Notre service de s\u00e9lection de la litt\u00e9rature s\u2019appuie sur une base de donn\u00e9es de r\u00e9f\u00e9rence mondiale syst\u00e9matique.<\/p><p>Le nombre \u00e9lev\u00e9 de substances actives actuellement surveill\u00e9es nous permet d\u2019\u00eatre hautement comp\u00e9titifs sur le service.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1176\" class=\"elementor-tab-title\" data-tab=\"6\" role=\"button\" aria-controls=\"elementor-tab-content-1176\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">GESTION DES SIGNAUX <\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-1176\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"6\" role=\"region\" aria-labelledby=\"elementor-tab-title-1176\"><p>Nous pouvons vous assister dans la planification des activit\u00e9s de d\u00e9tection de signaux et entreprendre la revue cumulative des donn\u00e9es de s\u00e9curit\u00e9.<\/p><p>Avec un processus efficace et une \u00e9quipe m\u00e9dicale en place, nous pouvons vous soutenir dans la gestion des signaux avec des services sp\u00e9cifiques ou complets.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1177\" class=\"elementor-tab-title\" data-tab=\"7\" role=\"button\" aria-controls=\"elementor-tab-content-1177\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">GESTION DE TIERS <\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-1177\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"7\" role=\"region\" aria-labelledby=\"elementor-tab-title-1177\"><p>La gestion des tiers de votre organisation, y compris les partenaires commerciaux et les fournisseurs, est essentielle \u00e0 votre syst\u00e8me de PV. Depuis la mise en \u0153uvre des accords d\u2019\u00e9change technique et de s\u00e9curit\u00e9 de PV, notre soutien comprend le contr\u00f4le de conformit\u00e9 et le suivi de vos partenaires et la strat\u00e9gie d\u2019\u00e9valuation des risques de mise en \u0153uvre.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1178\" class=\"elementor-tab-title\" data-tab=\"8\" role=\"button\" aria-controls=\"elementor-tab-content-1178\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">RAPPORTS DE S\u00c9CURIT\u00c9 <\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-1178\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"8\" role=\"region\" aria-labelledby=\"elementor-tab-title-1178\"><p>Gr\u00e2ce \u00e0 une haute performance de soumission et d\u2019\u00e9change des rapports individuels d\u2019effets ind\u00e9sirables (ICSR), nos solutions nous permettent d\u2019agir sur votre base de donn\u00e9es en saisissant et en traitant \u00e0 distance les donn\u00e9es de s\u00e9curit\u00e9 ou en vous fournissant notre base de donn\u00e9es de s\u00e9curit\u00e9 valid\u00e9e.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1179\" class=\"elementor-tab-title\" data-tab=\"9\" role=\"button\" aria-controls=\"elementor-tab-content-1179\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">S\u00c9CURIT\u00c9 DES ESSAIS CLINIQUES <\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-1179\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"9\" role=\"region\" aria-labelledby=\"elementor-tab-title-1179\"><p>Des proc\u00e9dures de pharmacovigilance conformes au cours de vos essais cliniques pr\u00e9- et post-commercialisation sont essentielles au succ\u00e8s de votre produit.<\/p><p>Par l\u2019interm\u00e9diaire de notre service clinique et de nos agents de s\u00e9curit\u00e9 des essais cliniques, nous nous assurons que les informations de pharmacovigilance des essais cliniques sont opportunes et correctement g\u00e9r\u00e9es. Nous soutenons votre organisation dans la gestion de SDEA, SAE, SUSAR et DSUR, ainsi que la soumission\/notification r\u00e9glementaire aux parties prenantes.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-11710\" class=\"elementor-tab-title\" data-tab=\"10\" role=\"button\" aria-controls=\"elementor-tab-content-11710\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">VIGILANCE DU DISPOSITIF <\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-11710\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"10\" role=\"region\" aria-labelledby=\"elementor-tab-title-11710\"><p>Nous fournissons une gamme compl\u00e8te de services pour les \u00e9tudes cliniques de dispositifs et les besoins post-enregistrement.<br \/>Notre \u00e9quipe d\u2019experts en vigilance conna\u00eet bien les diff\u00e9rentes exigences relatives aux dispositifs marqu\u00e9s CE et non marqu\u00e9s CE, aux dispositifs m\u00e9dicaux implantables et aux produits de combinaison m\u00e9dicaments-dispositifs.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-11711\" class=\"elementor-tab-title\" data-tab=\"11\" role=\"button\" aria-controls=\"elementor-tab-content-11711\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">GESTION LOCALE DES DONN\u00c9ES DE S\u00c9CURIT\u00c9 ET D\u00c9CLARATION DANS ELVIS <\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-11711\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"11\" role=\"region\" aria-labelledby=\"elementor-tab-title-11711\"><p>Le traitement du dossier dans la base de donn\u00e9es de s\u00e9curit\u00e9 sera effectu\u00e9 en appliquant la saisie des donn\u00e9es, le contr\u00f4le de la qualit\u00e9 et l\u2019\u00e9valuation m\u00e9dicale\u00a0;<\/p><p>3B Biotech sera responsable de la gestion du PORTAIL ELVIS pour le compte de ses clients.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t<script type=\"application\/ld+json\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"SYST\\u00c8ME DE GESTION QPPV ET PV\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p><strong>Avec un ensemble de proc\\u00e9dures et un personnel de pharmacovigilance qualifi\\u00e9, nous assurons la r\\u00e9alisation des fonctions cl\\u00e9s de PV, y compris le r\\u00f4le de QPPV au nom de votre organisation pour suivre ces t\\u00e2ches\\u00a0: <\\\/strong><\\\/p><p>Gestion du syst\\u00e8me de PV \\u2013 Point de contact principal pour Cas, EMA et inspection (disponibilit\\u00e9 24h\\\/24, 7j\\\/7) \\u2013 Supervision du profil de s\\u00e9curit\\u00e9 de votre portefeuille \\u2013 \\u00c9valuation de la balance b\\u00e9n\\u00e9fice-risque \\u2013 Examen et approbation de PASS \\u2013 Gestion des mesures de minimisation des risques<\\\/p>\"}},{\"@type\":\"Question\",\"name\":\"GESTION DES RISQUES\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>Nos experts en gestion des risques peuvent vous assister dans l\\u2019\\u00e9laboration, la r\\u00e9vision et la soumission d\\u2019un plan de gestion des risques (PGR) classifiant les risques importants, identifi\\u00e9s et potentiels. 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Nos techniciens qualifi\\u00e9s et nos experts m\\u00e9dicaux assurent un aper\\u00e7u continu de la balance b\\u00e9n\\u00e9fice\\\/risque ainsi que de l\\u2019efficacit\\u00e9 et de la s\\u00e9curit\\u00e9 des produits.<\\\/p>\"}},{\"@type\":\"Question\",\"name\":\"S\\u00c9LECTION DE LA LITT\\u00c9RATURE\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>Notre service de s\\u00e9lection de la litt\\u00e9rature s\\u2019appuie sur une base de donn\\u00e9es de r\\u00e9f\\u00e9rence mondiale syst\\u00e9matique.<\\\/p><p>Le nombre \\u00e9lev\\u00e9 de substances actives actuellement surveill\\u00e9es nous permet d\\u2019\\u00eatre hautement comp\\u00e9titifs sur le service.<\\\/p>\"}},{\"@type\":\"Question\",\"name\":\"GESTION DES SIGNAUX\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>Nous pouvons vous assister dans la planification des activit\\u00e9s de d\\u00e9tection de signaux et entreprendre la revue cumulative des donn\\u00e9es de s\\u00e9curit\\u00e9.<\\\/p><p>Avec un processus efficace et une \\u00e9quipe m\\u00e9dicale en place, nous pouvons vous soutenir dans la gestion des signaux avec des services sp\\u00e9cifiques ou complets.<\\\/p>\"}},{\"@type\":\"Question\",\"name\":\"GESTION DE TIERS\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>La gestion des tiers de votre organisation, y compris les partenaires commerciaux et les fournisseurs, est essentielle \\u00e0 votre syst\\u00e8me de PV. Depuis la mise en \\u0153uvre des accords d\\u2019\\u00e9change technique et de s\\u00e9curit\\u00e9 de PV, notre soutien comprend le contr\\u00f4le de conformit\\u00e9 et le suivi de vos partenaires et la strat\\u00e9gie d\\u2019\\u00e9valuation des risques de mise en \\u0153uvre.<\\\/p>\"}},{\"@type\":\"Question\",\"name\":\"RAPPORTS DE S\\u00c9CURIT\\u00c9\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>Gr\\u00e2ce \\u00e0 une haute performance de soumission et d\\u2019\\u00e9change des rapports individuels d\\u2019effets ind\\u00e9sirables (ICSR), nos solutions nous permettent d\\u2019agir sur votre base de donn\\u00e9es en saisissant et en traitant \\u00e0 distance les donn\\u00e9es de s\\u00e9curit\\u00e9 ou en vous fournissant notre base de donn\\u00e9es de s\\u00e9curit\\u00e9 valid\\u00e9e.<\\\/p>\"}},{\"@type\":\"Question\",\"name\":\"S\\u00c9CURIT\\u00c9 DES ESSAIS CLINIQUES\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>Des proc\\u00e9dures de pharmacovigilance conformes au cours de vos essais cliniques pr\\u00e9- et post-commercialisation sont essentielles au succ\\u00e8s de votre produit.<\\\/p><p>Par l\\u2019interm\\u00e9diaire de notre service clinique et de nos agents de s\\u00e9curit\\u00e9 des essais cliniques, nous nous assurons que les informations de pharmacovigilance des essais cliniques sont opportunes et correctement g\\u00e9r\\u00e9es. Nous soutenons votre organisation dans la gestion de SDEA, SAE, SUSAR et DSUR, ainsi que la soumission\\\/notification r\\u00e9glementaire aux parties prenantes.<\\\/p>\"}},{\"@type\":\"Question\",\"name\":\"VIGILANCE DU DISPOSITIF\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>Nous fournissons une gamme compl\\u00e8te de services pour les \\u00e9tudes cliniques de dispositifs et les besoins post-enregistrement.<br \\\/>Notre \\u00e9quipe d\\u2019experts en vigilance conna\\u00eet bien les diff\\u00e9rentes exigences relatives aux dispositifs marqu\\u00e9s CE et non marqu\\u00e9s CE, aux dispositifs m\\u00e9dicaux implantables et aux produits de combinaison m\\u00e9dicaments-dispositifs.<\\\/p>\"}},{\"@type\":\"Question\",\"name\":\"GESTION LOCALE DES DONN\\u00c9ES DE S\\u00c9CURIT\\u00c9 ET D\\u00c9CLARATION DANS ELVIS\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>Le traitement du dossier dans la base de donn\\u00e9es de s\\u00e9curit\\u00e9 sera effectu\\u00e9 en appliquant la saisie des donn\\u00e9es, le contr\\u00f4le de la qualit\\u00e9 et l\\u2019\\u00e9valuation m\\u00e9dicale\\u00a0;<\\\/p><p>3B Biotech sera responsable de la gestion du PORTAIL ELVIS pour le compte de ses clients.<\\\/p>\"}}]}<\/script>\n\t\t\t\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<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-8ee930f elementor-section-full_width elementor-section-content-middle elementor-section-height-default elementor-section-height-default\" data-id=\"8ee930f\" 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-dcf548a animated-slow elementor-invisible\" data-id=\"dcf548a\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;,&quot;animation_delay&quot;:500}\">\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-c4ebdfc elementor-widget elementor-widget-heading\" data-id=\"c4ebdfc\" 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\">Notre r\u00e9seau de PV<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b2b6d5c elementor-widget elementor-widget-text-editor\" data-id=\"b2b6d5c\" 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>3B Biotech Research est votre fournisseur de services de pharmacovigilance mondiaux et locaux. Nous pouvons offrir des services de pharmacovigilance locaux sur mesure \u00e0 travers un r\u00e9seau de prestataires locaux hautement qualifi\u00e9s et exp\u00e9riment\u00e9s sur les sujets de pharmacovigilance. Nos partenaires de confiance sont des entreprises de taille moyenne que nous avons s\u00e9lectionn\u00e9es et qualifi\u00e9es au fil des ans.\u00a0<\/p><p>Gr\u00e2ce \u00e0 ce r\u00e9seau, nous assurons \u00e0 nos clients\u00a0:<\/p><ul><li>un haut respect des exigences locales en mati\u00e8re de pharmacovigilance\u00a0;<\/li><li>un \u00e9change rapide et efficace d\u2019informations sur la s\u00e9curit\u00e9\u00a0;<\/li><li>une haute qualit\u00e9 des activit\u00e9s de traduction\u00a0;<\/li><li>une liste compl\u00e8te des revues scientifiques locales non index\u00e9es\u00a0;<\/li><li>un personnel qualifi\u00e9 pour agir en tant que contact local ou personne responsable en mati\u00e8re de pharmacovigilance\u00a0;<\/li><li>un syst\u00e8me de PV mondial et sur mesure.<\/li><\/ul>\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-f137273 animated-slow elementor-invisible\" data-id=\"f137273\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;,&quot;animation_delay&quot;:800,&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\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<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>PHARMACOVIGILANCE ET S\u00c9CURIT\u00c9 CLINIQUE 3B Biotech propose une gamme de services de pharmacovigilance locaux et mondiaux de haute qualit\u00e9. Gr\u00e2ce \u00e0 notre soci\u00e9t\u00e9 s\u0153ur GB Pharma, nous fournissons des solutions efficaces, comprenant le r\u00f4le de EU-QPPV, pour maintenir \u00e9galement votre syst\u00e8me de PV en Europe Un ensemble complet et personnalis\u00e9 de services de pharmacovigilance locaux &#8230; <a title=\"Pharmacovigilance\" class=\"read-more\" href=\"https:\/\/3bbiotech.com\/fr\/pharmacovigilance\/\" aria-label=\"Read more about Pharmacovigilance\">Read more<\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"content-type":"","footnotes":""},"categories":[29],"tags":[92],"class_list":{"0":"post-2981","1":"page","2":"type-page","3":"status-publish","5":"category-pharmacovigilance-fr","6":"tag-pharmacovigilance-et-securite-clinique"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ 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