{"id":9458,"date":"2021-08-20T12:28:31","date_gmt":"2021-08-20T12:28:31","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=9458"},"modified":"2023-03-10T09:43:35","modified_gmt":"2023-03-10T09:43:35","slug":"medical-device-risk-management-rmp-template-free","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/fr\/medical-device-risk-management-rmp-template-free\/","title":{"rendered":"Mod\u00e8le de plan de gestion des risques m\u00e9dicaux (RMP) (GRATUIT)"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_45_1 counter-flat ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\">Table des mati\u00e8res<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" area-label=\"ez-toc-toggle-icon-1\"><label for=\"item-69f29345c94b2\" aria-label=\"Table des mati\u00e8res\"><span style=\"display: flex;align-items: center;width: 35px;height: 30px;justify-content: center;direction:ltr;\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewbox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewbox=\"0 0 24 24\" version=\"1.2\" baseprofile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/label><input  type=\"checkbox\" id=\"item-69f29345c94b2\"><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1' ><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.kolabtree.com\/blog\/fr\/medical-device-risk-management-rmp-template-free\/#What_is_a_Risk_Management_Plan_RMP\" title=\"Qu&#039;est-ce qu&#039;un plan de gestion des risques (PGR) ?\">Qu'est-ce qu'un plan de gestion des risques (PGR) ?<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/fr\/medical-device-risk-management-rmp-template-free\/#Why_do_you_need_an_RMP_template\" title=\"Pourquoi avez-vous besoin d&#039;un mod\u00e8le de PGR ?\">Pourquoi avez-vous besoin d'un mod\u00e8le de PGR ?<\/a><\/li><\/ul><\/nav><\/div>\n<p><em><a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/nare-simonyan\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=RMPfreetemplate\">Nare Simonyan<\/a>sp\u00e9cialiste des affaires r\u00e9glementaires et des essais cliniques sur Kolabtree, fournit un aper\u00e7u de la situation. <a href=\"https:\/\/www.kolabtree.com\/blog\/what-is-regulatory-dossier-and-what-does-it-contain\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=RMPfreetemplate\">Plan de gestion des risques<\/a> (RMP) que les entreprises de dispositifs m\u00e9dicaux et de produits pharmaceutiques peuvent utiliser comme point de r\u00e9f\u00e9rence pour leurs soumissions de produits.<\/em><\/p>\n<h2><span class=\"ez-toc-section\" id=\"What_is_a_Risk_Management_Plan_RMP\"><\/span>Qu'est-ce qu'un plan de gestion des risques (PGR) ?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Un plan de gestion des risques ou PGR est un document qui d\u00e9taille les caract\u00e9ristiques de s\u00e9curit\u00e9 du m\u00e9dicament, en particulier les mesures d'urgence mises en place pour r\u00e9duire la gravit\u00e9 du risque pour les patients. Le mod\u00e8le de PGR exige \u00e9galement des entreprises qu'elles expliquent comment elles seront impliqu\u00e9es dans les \u00e9tudes en cours pour minimiser ou pr\u00e9venir les risques et am\u00e9liorer la s\u00e9curit\u00e9 du m\u00e9dicament.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Why_do_you_need_an_RMP_template\"><\/span>Pourquoi avez-vous besoin d'un mod\u00e8le de PGR ?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Les entreprises sont tenues de soumettre un plan de gestion des risques aux organes m\u00e9dicaux comp\u00e9tents, tels que l'Agence europ\u00e9enne des m\u00e9dicaments (EMA), lorsqu'elles demandent une autorisation de mise sur le march\u00e9. En outre, toute autorit\u00e9 nationale comp\u00e9tente (ANC) peut demander un PGR pour les produits m\u00e9dicaux autoris\u00e9s au niveau national.<\/p>\n<p>Ce mod\u00e8le gratuit de PGR vous servira de point de r\u00e9f\u00e9rence lorsque vous devrez soumettre un plan de gestion des risques pour votre nouveau produit.<\/p>\n<div class=\"forminator-ui forminator-custom-form forminator-custom-form-10527 forminator-design--flat  forminator_ajax\" data-forminator-render=\"0\" data-form=\"forminator-module-10527\" data-uid=\"69f29345c201c\"><br\/><\/div><form\n\t\t\t\tid=\"forminator-module-10527\"\n\t\t\t\tclass=\"forminator-ui forminator-custom-form forminator-custom-form-10527 forminator-design--flat  forminator_ajax\"\n\t\t\t\tmethod=\"post\"\n\t\t\t\tdata-forminator-render=\"0\"\n\t\t\t\tdata-form-id=\"10527\"\n\t\t\t\t\n\t\t\t\tdata-design=\"flat\"\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\tdata-grid=\"open\"\n\t\t\t\t\n\t\t\t\t\n\t\t\t\tstyle=\"display: none;\"\n\t\t\t\t\n\t\t\t\tdata-uid=\"69f29345c201c\" action=\"\"\n\t\t\t><div class=\"forminator-response-message forminator-error\" aria-hidden=\"true\"><\/div><div class=\"forminator-row\"><div id=\"email-1\" class=\"forminator-col forminator-col-12\"><div class=\"forminator-field\"><label for=\"forminator-field-email-1_69f29345c201c\" class=\"forminator-label\">Adresse \u00e9lectronique <span class=\"forminator-required\">*<\/span><\/label><input type=\"email\" name=\"email-1\" value=\"\" placeholder=\"\" id=\"forminator-field-email-1_69f29345c201c\" class=\"forminator-input forminator-email--field\" data-required=\"1\" aria-required=\"true\" \/><\/div><\/div><\/div><input type=\"hidden\" name=\"referer_url\" value=\"\" \/><div class=\"forminator-row forminator-row-last\"><div class=\"forminator-col\"><div class=\"forminator-field\"><button class=\"forminator-button forminator-button-submit\">Download the Free Template Here.<\/button><\/div><\/div><\/div><input type=\"hidden\" id=\"forminator_nonce\" name=\"forminator_nonce\" value=\"74690d92fd\" \/><input type=\"hidden\" name=\"_wp_http_referer\" value=\"\/blog\/fr\/wp-json\/wp\/v2\/posts\/9458\" \/><input type=\"hidden\" name=\"form_id\" value=\"10527\"><input type=\"hidden\" name=\"page_id\" value=\"9458\"><input type=\"hidden\" name=\"form_type\" value=\"default\"><input type=\"hidden\" name=\"current_url\" value=\"https:\/\/www.kolabtree.com\/blog\/fr\/medical-device-risk-management-rmp-template-free\/\"><input type=\"hidden\" name=\"render_id\" value=\"0\"><input type=\"hidden\" name=\"action\" value=\"forminator_submit_form_custom-forms\"><input type=\"hidden\" name=\"trp-form-language\" value=\"fr\"\/><\/form><p>Ce mod\u00e8le de PGR a \u00e9t\u00e9 r\u00e9dig\u00e9 par Nare Simonyan, collaborateur ind\u00e9pendant de Kolabtree. a <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-affairs?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=RMPfreetemplate\">consultant ind\u00e9pendant en r\u00e9glementation<\/a> avec un doctorat en sciences pharmaceutiques. Elle offre son expertise en mati\u00e8re de conseil sur une grande vari\u00e9t\u00e9 de sujets, tels que les essais cliniques, la conformit\u00e9 r\u00e9glementaire, la r\u00e9daction scientifique et la r\u00e9vision m\u00e9dicale. Contactez directement Nare <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/nare-simonyan?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=RMPfreetemplate\">ici.<\/a><\/p>\n<p><a href=\"https:\/\/www.kolabtree.com\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=RMPfreetemplate\">Kolabtree<\/a> vous permet d'acc\u00e9der directement \u00e0 un r\u00e9seau mondial d'experts scientifiques et industriels. Nos experts proposent des services en freelance dans une grande vari\u00e9t\u00e9 de domaines de niche. Vous cherchez \u00e0 engager un expert ?<a href=\"https:\/\/www.kolabtree.com\/create-project?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=RMPfreetemplate\"> Publier un projet gratuitement<\/a>ou parcourez notre<a href=\"https:\/\/www.kolabtree.com\/find-an-expert?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=RMPfreetemplate\"> les freelances les mieux not\u00e9s<\/a>.<\/p>","protected":false},"excerpt":{"rendered":"<p>Nare Simonyan, sp\u00e9cialiste des affaires r\u00e9glementaires et des essais cliniques chez Kolabtree, propose un mod\u00e8le de plan de gestion des risques (PGR) que les entreprises de dispositifs m\u00e9dicaux et de produits pharmaceutiques peuvent utiliser comme point de r\u00e9f\u00e9rence pour leurs soumissions de produits. Qu'est-ce qu'un plan de gestion des risques (PGR) ? Un plan de gestion des risques ou PGR est un document qui d\u00e9taille la s\u00e9curit\u00e9 du produit m\u00e9dical.<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/fr\/medical-device-risk-management-rmp-template-free\/\" title=\"Lire la suite\">Lire la suite<\/a><\/div>","protected":false},"author":605,"featured_media":9463,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[442,317,247,443,540,653,516],"tags":[45,59,21,38],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.1 (Yoast SEO v20.1) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Medical Risk Management Plan (RMP) Template (FREE) -<\/title>\n<meta name=\"description\" content=\"Looking to draft a risk management plan? 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