{"id":1000011429,"date":"2023-05-08T10:07:00","date_gmt":"2023-05-08T08:07:00","guid":{"rendered":"https:\/\/forum-engagement.org\/?p=1000011429"},"modified":"2023-05-02T10:08:48","modified_gmt":"2023-05-02T08:08:48","slug":"pharmacovigilance","status":"publish","type":"post","link":"https:\/\/forum-engagement.org\/2024\/pharmacovigilance\/","title":{"rendered":"Pharmacovigilance"},"content":{"rendered":"\n<p>Chiesi France SAS&nbsp;dispose d\u2019un syst\u00e8me de pharmacovigilance afin d\u2019assumer la responsabilit\u00e9 associ\u00e9e \u00e0 nos m\u00e9dicaments (qu\u2019ils soient commercialis\u00e9s ou en cours de d\u00e9veloppement clinique) et pour prendre les mesures appropri\u00e9es si n\u00e9cessaire. Nous nous assurons que toutes les informations pertinentes concernant le rapport b\u00e9n\u00e9fice\/risque de nos m\u00e9dicaments sont constamment \u00e9valu\u00e9es. Lorsque des questions importantes portant sur la s\u00e9curit\u00e9 se posent, le cas \u00e9ch\u00e9ant, nous en avisons rapidement les professionnels de la sant\u00e9, les patients et les agences r\u00e9glementaires concern\u00e9es conform\u00e9ment \u00e0 la l\u00e9gislation en vigueur.<\/p>\n\n\n\n<p><strong>Qu\u2019est-ce que la Pharmacovigilance?<\/strong><\/p>\n\n\n\n<p>La pharmacovigilance correspond \u00e0 la science et aux activit\u00e9s relatives \u00e0 la d\u00e9tection, l\u2019\u00e9valuation, la compr\u00e9hension et la pr\u00e9vention des effets ind\u00e9sirables et de tout autre probl\u00e8me li\u00e9 \u00e0 l\u2019utilisation d\u2019un m\u00e9dicament (R\u00e9f. Organisation mondiale de la sant\u00e9, OMS.&nbsp;<em>The importance of pharmacovigilance: safety monitoring of medicinal products,<\/em>&nbsp;Geneva, OMS, 2002).<\/p>\n\n\n\n<p>En accord avec cette d\u00e9finition g\u00e9n\u00e9rale, les principaux objectifs de la pharmacovigilance conform\u00e9ment \u00e0 la l\u00e9gislation europ\u00e9enne applicable comprennent:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>la pr\u00e9vention des risques&nbsp;associ\u00e9s aux r\u00e9actions ind\u00e9sirables chez l\u2019homme;<\/li><li>la promotion du bon usage&nbsp;des m\u00e9dicaments, notamment en fournissant des informations sur la s\u00e9curit\u00e9 des m\u00e9dicaments en temps opportun aux patients, aux professionnels de la sant\u00e9 et au public.<\/li><\/ul>\n\n\n\n<p>La pharmacovigilance est donc une activit\u00e9 contribuant \u00e0 la protection des patients et de la sant\u00e9 publique.<\/p>\n\n\n\n<p><strong>Qu\u2019est-ce qu\u2019un effet ind\u00e9sirable \u00e0 un m\u00e9dicament?<\/strong><\/p>\n\n\n\n<p>Une r\u00e9action&nbsp;\u00e0 un m\u00e9dicament qui est nocive et non voulue&nbsp;(dans ce contexte, r\u00e9action&nbsp;signifie que le lien de causalit\u00e9 entre un m\u00e9dicament et un \u00e9v\u00e8nement ind\u00e9sirable est au moins une possibilit\u00e9 raisonnable).<\/p>\n\n\n\n<p>Les r\u00e9actions ind\u00e9sirables peuvent se produire suite \u00e0 l\u2019emploi du produit dans le cadre ou en dehors des conditions de l\u2019autorisation de mise sur le march\u00e9 ou suite \u00e0 une exposition professionnelle. Les conditions d\u2019emploi en dehors de l\u2019autorisation de mise sur le march\u00e9 comprennent l\u2019emploi hors indication, le surdosage, le m\u00e9susage, l\u2019abus et les erreurs de m\u00e9dication.<\/p>\n\n\n\n<p><strong>Information sur la fa\u00e7on de signaler les r\u00e9actions ind\u00e9sirables d\u2019un m\u00e9dicament<\/strong><\/p>\n\n\n\n<p><strong>Si vous \u00eates en France<\/strong><\/p>\n\n\n\n<p>Tout \u00e9v\u00e8nement malencontreux qui se produit suite \u00e0 un traitement m\u00e9dical doit \u00eatre signal\u00e9 sans d\u00e9lai au m\u00e9decin traitant ou au pharmacien.<\/p>\n\n\n\n<p>Si vous voulez signaler une r\u00e9action ind\u00e9sirable li\u00e9e aux m\u00e9dicaments de Chiesi, vous pouvez la signaler \u00e0 votre Centre R\u00e9gional de Pharmacovigilance (CRPV) en suivant les instructions indiqu\u00e9es dans le lien ci-dessous :<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">&nbsp;&nbsp;<a href=\"https:\/\/signalement.social-sante.gouv.fr\/\" target=\"_blank\" rel=\"noreferrer noopener\">SITE DU GOUVERNEMENT &#8211; D\u00c9CLARER UN EFFET IND\u00c9SIRABLE<\/a>&nbsp;<\/h4>\n\n\n\n<h3 class=\"wp-block-heading\">&nbsp;<\/h3>\n\n\n\n<p><strong>OU contacter directement le D\u00e9partement de pharmacovigilance de Chiesi:<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td>&nbsp;<img decoding=\"async\" src=\"https:\/\/www.chiesi.fr\/img\/phone.png\" alt=\"\">&nbsp; &nbsp;Appeler le&nbsp;&nbsp;<\/td><td>&nbsp;<img decoding=\"async\" src=\"https:\/\/www.chiesi.fr\/img\/fax.png\" alt=\"\">&nbsp;&nbsp;&nbsp;envoyer un fax au&nbsp;&nbsp;<\/td><td>&nbsp;<img decoding=\"async\" src=\"https:\/\/www.chiesi.fr\/img\/emailf.png\" alt=\"\">&nbsp; &nbsp;envoyer un e-mail \u00e0&nbsp;&nbsp;<\/td><\/tr><tr><td>&nbsp;<strong>0800 10 25 81<\/strong>&nbsp;<\/td><td><strong>01 47 68 48 08<\/strong>&nbsp;<\/td><td><a href=\"mailto:pharmacovigilance@chiesi.com\">pharmacovigilance@chiesi.com<\/a>&nbsp;<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><em>Dans le cadre du signalement d&rsquo;un \u00e9v\u00e9nement ind\u00e9sirable survenu sur une sp\u00e9cialit\u00e9 pharmaceutique Chiesi S.A.S., vous serez amen\u00e9 \u00e0 transmettre des donn\u00e9es \u00e0 caract\u00e8re personnel par t\u00e9l\u00e9phone, fax ou courriel.<\/em><br><em>Le traitement des informations vous concernant a \u00e9t\u00e9 d\u00e9clar\u00e9 \u00e0 la CNIL pour la gestion des donn\u00e9es de sant\u00e9 recueillies dans le cadre de la pharmacovigilance des m\u00e9dicaments post\u00e9rieurement \u00e0 leur mise sur le march\u00e9.<\/em><br><em>Les destinataires des informations vous concernant sont les services habilit\u00e9s de CHIESI ou le cas \u00e9ch\u00e9ant ses sous-traitants.<\/em><\/p>\n\n\n\n<p><em>Conform\u00e9ment \u00e0 la loi \u00ab Informatique et Libert\u00e9s \u00bb du 6 janvier 1978 modifi\u00e9e et au R\u00e8glement G\u00e9n\u00e9ral sur la Protection des Donn\u00e9es du 27 avril 2016, vous b\u00e9n\u00e9ficiez d\u2019un droit d\u2019acc\u00e8s, de rectification, de suppression, de limitation, de portabilit\u00e9 et d\u2019opposition (lorsqu\u2019ils s\u2019appliquent) aux informations qui vous concernent.<\/em><\/p>\n\n\n\n<p><em>Vous pouvez exercer ces droits en vous adressant au service DPO du si\u00e8ge de CHIESI \u00e0 l\u2019adresse&nbsp;<u><a href=\"mailto:dpo.fr@chiesi.com\">dpo.fr@chiesi.com<\/a><\/u>.<\/em><\/p>\n\n\n\n<p><em>De plus, vous disposez d\u2019un droit d\u2019introduire une r\u00e9clamation aupr\u00e8s de la Commission Nationale de l\u2019Informatique et des Libert\u00e9s (CNIL).<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Chiesi France SAS&nbsp;dispose d\u2019un syst\u00e8me de pharmacovigilance afin d\u2019assumer la responsabilit\u00e9 associ\u00e9e \u00e0 nos m\u00e9dicaments (qu\u2019ils soient commercialis\u00e9s ou en cours de d\u00e9veloppement clinique) et pour prendre les mesures appropri\u00e9es si n\u00e9cessaire. Nous nous assurons que toutes les informations pertinentes concernant le rapport b\u00e9n\u00e9fice\/risque de nos m\u00e9dicaments sont constamment \u00e9valu\u00e9es. Lorsque des questions importantes portant [&hellip;]<\/p>\n","protected":false},"author":56,"featured_media":1000011430,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":{"0":"post-1000011429","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-non-classe"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.5 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Pharmacovigilance | Forum Engagement<\/title>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharmacovigilance | Forum Engagement\" \/>\n<meta property=\"og:description\" content=\"Chiesi France SAS&nbsp;dispose d\u2019un syst\u00e8me de pharmacovigilance afin d\u2019assumer la responsabilit\u00e9 associ\u00e9e \u00e0 nos m\u00e9dicaments (qu\u2019ils soient commercialis\u00e9s ou en cours de d\u00e9veloppement clinique) et pour prendre les mesures appropri\u00e9es si n\u00e9cessaire. Nous nous assurons que toutes les informations pertinentes concernant le rapport b\u00e9n\u00e9fice\/risque de nos m\u00e9dicaments sont constamment \u00e9valu\u00e9es. Lorsque des questions importantes portant [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/forum-engagement.org\/2024\/pharmacovigilance\/\" \/>\n<meta property=\"og:site_name\" content=\"Forum Engagement\" \/>\n<meta property=\"article:published_time\" content=\"2023-05-08T08:07:00+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/forum-engagement.org\/2024\/wp-content\/uploads\/2023\/05\/Capture-decran-2023-05-02-a-10.08.25-1024x679.png\" \/>\n\t<meta property=\"og:image:width\" content=\"1024\" \/>\n\t<meta property=\"og:image:height\" content=\"679\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"CHIESI\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"\u00c9crit par\" \/>\n\t<meta name=\"twitter:data1\" content=\"CHIESI\" \/>\n\t<meta name=\"twitter:label2\" content=\"Dur\u00e9e de lecture estim\u00e9e\" \/>\n\t<meta name=\"twitter:data2\" 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