{"id":4365,"date":"2022-06-03T17:02:45","date_gmt":"2022-06-03T15:02:45","guid":{"rendered":"https:\/\/www.universalmedica.com\/?p=4365"},"modified":"2022-06-03T17:04:09","modified_gmt":"2022-06-03T15:04:09","slug":"revision-des-bonnes-pratiques-de-pharmacovigilance-en-france","status":"publish","type":"post","link":"https:\/\/www.universalmedica.com\/fr\/revision-des-bonnes-pratiques-de-pharmacovigilance-en-france\/","title":{"rendered":"R\u00e9vision des Bonnes Pratiques de PharmacoVigilance en France"},"content":{"rendered":"<p>Nous avons le plaisir de partager notre synth\u00e8se de la r\u00e9vision des <strong>B<\/strong>onnes <strong>P<\/strong>ratiques de <strong>P<\/strong>harmaco<strong>V<\/strong>igilance en France\u00a0: si cette r\u00e9vision n\u2019am\u00e8ne pas de grands changements dans le syst\u00e8me national, elle apporte des pr\u00e9cisions sur les processus en place ainsi qu\u2019une mise \u00e0 jour de la description des processus qui ont \u00e9volu\u00e9s depuis la pr\u00e9c\u00e9dente version BPPV. <\/p>\n<p><u>Parmi les \u00e9volutions du texte, on peut noter :<\/u><\/p>\n<ul>\n<li>Ajout et modification d\u2019un certain nombre de d\u00e9finitions notamment sur les situations sp\u00e9ciales.<\/li>\n<li>Concernant les professionnels de sant\u00e9, \u00e9claircissement sur les obligations et les possibilit\u00e9s de chacun en termes de d\u00e9claration des cas ainsi que sur les modalit\u00e9s de ces d\u00e9clarations.<\/li>\n<li>Concernant les patients, il a \u00e9t\u00e9 ajout\u00e9 la d\u00e9claration aux centres d\u2019\u00e9valuation et d\u2019information sur la pharmacod\u00e9pendance.<\/li>\n<li>Pour les titulaires \/ exploitants\u00a0:\n<ul>\n<li>Mise \u00e0 jour des modalit\u00e9s de d\u00e9claration du RPV.<\/li>\n<li>Ajout d\u2019une nouvelle mission pour le RPV\u00a0: surveillance de la mise \u00e0 jour de l\u2019information produit<\/li>\n<li>Clarification des modalit\u00e9s de documentation des cas de PV notamment aupr\u00e8s des patients.<\/li>\n<li>Ajout des modalit\u00e9s de d\u00e9claration des signaux urgents de s\u00e9curit\u00e9 (\u00ab Emerging safety Issues\u00a0\u00bb)<\/li>\n<li>Renforcement de l\u2019implication de l\u2019exploitant dans la gestion des mesures de minimisation des risques.<\/li>\n<li>Renforcement \/ D\u00e9tails concernant la tra\u00e7abilit\u00e9 des indicateurs et des contr\u00f4les qualit\u00e9s.<\/li>\n<\/ul>\n<\/li>\n<li>Concernant les CRPVs, renforcement de leurs implications dans la gestion des erreurs m\u00e9dicamenteuses et les signaux.<\/li>\n<\/ul>\n<p>En cons\u00e9quence, <strong><u>nos recommandations d\u2019actions<\/u><\/strong>\u00a0:<\/p>\n<ul>\n<li>Pour les RPV \/ exploitants, s\u2019assurer qu\u2019ils ont les moyens d\u2019exercer leurs responsabilit\u00e9s suppl\u00e9mentaires \/ additionnelles. <\/li>\n<li>V\u00e9rifier le contenu des diff\u00e9rents documents qualit\u00e9s et autres documents (supports de formations, accord d\u2019\u00e9changes de donn\u00e9es, etc.) pour int\u00e9grer les diff\u00e9rentes pr\u00e9cisions apport\u00e9es par ce texte.<\/li>\n<\/ul>\n<p>Nous restons, bien \u00e9videmment \u00e0 votre disposition pour tout \u00e9clairage suppl\u00e9mentaire. <a href=\"\/fr\/contact\/\">N\u2019h\u00e9sitez pas \u00e0 contacter notre expert<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Nous avons le plaisir de partager notre synth\u00e8se de la r\u00e9vision des Bonnes Pratiques de PharmacoVigilance en France\u00a0: si cette r\u00e9vision n\u2019am\u00e8ne pas de grands changements dans le syst\u00e8me national, elle apporte des pr\u00e9cisions sur les processus en place ainsi qu\u2019une mise \u00e0 jour de la description des processus qui ont \u00e9volu\u00e9s depuis la pr\u00e9c\u00e9dente [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":4367,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[134],"tags":[],"class_list":["post-4365","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharmacovigilance"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - 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