{"id":2807,"date":"2022-10-28T14:34:44","date_gmt":"2022-10-28T14:34:44","guid":{"rendered":"https:\/\/zenithpv.ca\/?p=565"},"modified":"2025-10-25T13:33:45","modified_gmt":"2025-10-25T17:33:45","slug":"pratiques-actuelles-et-perspectives-davenir-du-programme-dinspection-des-bonnes-pratiques-de-pharmacovigilance-gvp","status":"publish","type":"post","link":"https:\/\/zenithpv.ca\/fr\/2022\/10\/28\/pratiques-actuelles-et-perspectives-davenir-du-programme-dinspection-des-bonnes-pratiques-de-pharmacovigilance-gvp\/","title":{"rendered":"Pratiques actuelles et perspectives d&#039;avenir du programme d&#039;inspection des bonnes pratiques de pharmacovigilance (BPP)"},"content":{"rendered":"<p>Lors de la conf\u00e9rence DIA 2022 \u00e0 Ottawa, Mme Myriam Salem, conseill\u00e8re principale en r\u00e9glementation et en application de la loi \u00e0 Sant\u00e9 Canada, a pr\u00e9sent\u00e9 les pratiques actuelles et les perspectives d&#039;avenir du Programme d&#039;inspection des bonnes pratiques de pharmacovigilance (BPP). Voici les points saillants de la s\u00e9ance, r\u00e9sum\u00e9s par vos partenaires PV chez Zenith PV.<\/p>\n<p class=\"reader-text-block__paragraph\"><strong>Inspections GVP :<\/strong><\/p>\n<p class=\"reader-text-block__paragraph\">Les inspections des PVG de Sant\u00e9 Canada ont repris en juillet 2020 gr\u00e2ce aux technologies num\u00e9riques. Un portail web de partage de documents, ePost Connect, a \u00e9t\u00e9 lanc\u00e9 et est toujours utilis\u00e9 aujourd&#039;hui. Des outils de visioconf\u00e9rence sont utilis\u00e9s pour faciliter les \u00e9changes avec les titulaires d&#039;autorisation de mise sur le march\u00e9, et l&#039;approche globale des inspections continuera d&#039;inclure des inspections sur place, virtuelles et hybrides, tandis que Sant\u00e9 Canada explore continuellement des moyens d&#039;am\u00e9liorer l&#039;efficacit\u00e9 et l&#039;efficience de ses processus.<\/p>\n<p class=\"reader-text-block__paragraph\">En 2022, Sant\u00e9 Canada pr\u00e9voit d&#039;auditer 80 des 549 titulaires d&#039;autorisation de mise sur le march\u00e9 (TAMM). Environ 151 titulaires d&#039;autorisation de mise sur le march\u00e9 (TAMM) sont audit\u00e9s chaque ann\u00e9e et Sant\u00e9 Canada utilise une approche bas\u00e9e sur les risques pour s\u00e9lectionner les TMM \u00e0 auditer. Les principaux crit\u00e8res de s\u00e9lection des titulaires d&#039;autorisation de mise sur le march\u00e9 \u00e0 auditer sont les suivants\u00a0:<\/p>\n<ul>\n<li>Informations re\u00e7ues des bureaux d&#039;examen du MHPD<\/li>\n<li>Historique de conformit\u00e9 du MAH<\/li>\n<li>Effets ind\u00e9sirables graves signal\u00e9s \u00e0 Canada Vigilance<\/li>\n<li>Portefeuille de produits et classes th\u00e9rapeutiques du MAH associ\u00e9s \u00e0 des effets ind\u00e9sirables plus \u00e9lev\u00e9s<\/li>\n<li>Conditions impos\u00e9es aux DIN<\/li>\n<li>Temps \u00e9coul\u00e9 depuis la derni\u00e8re inspection<\/li>\n<\/ul>\n<p class=\"reader-text-block__paragraph\">L&#039;agence a \u00e9galement fourni une ventilation des observations r\u00e9glementaires observ\u00e9es en 2021-22. Les observations les plus courantes sont pr\u00e9sent\u00e9es ci-dessous, en chiffres r\u00e9els et en pourcentage du total.<\/p>\n<ul>\n<li>C.01.017 D\u00e9claration des effets ind\u00e9sirables graves des m\u00e9dicaments 209 (65%)<\/li>\n<li>C.01.018 Rapport sommaire annuel \u2013 65 (20%)<\/li>\n<li>C.01.019 Rapport sommaire relatif au probl\u00e8me - 17 (5%)<\/li>\n<li>C.01.020 Tenue des dossiers \u2013 24 (8%)<\/li>\n<li>C.08.007\/C.08.008 Nouveaux m\u00e9dicaments (D\u00e9faillance inhabituelle de l&#039;efficacit\u00e9 et conservation des dossiers) - 5 (8%)<\/li>\n<li>C.01.014.21 Conditions g\u00e9n\u00e9rales \u2013 1 (0%)<\/li>\n<\/ul>\n<p class=\"reader-text-block__paragraph\"><strong>Mises \u00e0 jour importantes du projet<\/strong><\/p>\n<p class=\"reader-text-block__paragraph\">L&#039;agence a \u00e9galement fourni une mise \u00e0 jour d\u00e9taill\u00e9e des principaux projets relevant de sa comp\u00e9tence actuelle. Parmi ceux-ci\u00a0:<\/p>\n<p class=\"reader-text-block__paragraph\"><strong>Utilisation de l&#039;intelligence artificielle en pharmacovigilance<\/strong>\u00a0Dans des domaines tels que le traitement des dossiers, le d\u00e9pistage de la litt\u00e9rature, la d\u00e9tection des signaux, l&#039;\u00e9tiquetage des produits et la conformit\u00e9. L&#039;agence a conclu que la gravit\u00e9 et l&#039;anticipation des risques n\u00e9cessiteront une expertise humaine pour \u00e9valuer tous les facteurs, et que le recours \u00e0 une supervision humaine est n\u00e9cessaire pour garantir que l&#039;IA ne perp\u00e9tue pas un biais d\u00fb \u00e0 un apprentissage inad\u00e9quat. \u00c0 mesure que la position de Sant\u00e9 Canada sur l&#039;utilisation de l&#039;IA \u00e9volue, les titulaires d&#039;autorisations de mise sur le march\u00e9 (TAMM) sont tenus de se conformer \u00e0 la r\u00e9glementation de la m\u00eame mani\u00e8re, avec ou sans IA.<\/p>\n<p class=\"reader-text-block__paragraph\"><strong>Projet de surveillance de la conformit\u00e9 des OSC-tRMP\u00a0<\/strong>Dans le cadre du PRMP, GVP a lanc\u00e9 un projet de surveillance de la conformit\u00e9 (PSC) afin d&#039;\u00e9valuer la conformit\u00e9 aux Plans de gestion des risques cibl\u00e9s pour les opio\u00efdes (PGR-CSO) au Canada. La s\u00e9lection des titulaires d&#039;autorisation de mise sur le march\u00e9 (DAMM) a \u00e9t\u00e9 effectu\u00e9e selon des crit\u00e8res fond\u00e9s sur les risques pour la s\u00e9curit\u00e9, ainsi que d&#039;autres crit\u00e8res tels que le type d&#039;engagements inclus dans les PGR-CSO. L&#039;Agence pr\u00e9voit mener \u00e0 bien les inspections, et les enseignements tir\u00e9s pourraient \u00e9clairer la mise en \u0153uvre des PGR.<\/p>\n<p class=\"reader-text-block__paragraph\"><strong>Conformit\u00e9 des titulaires d&#039;autorisation de mise sur le march\u00e9 pour les produits \u00e0 faible risque\u00a0<\/strong>Le GVP a lanc\u00e9 un projet pilote visant \u00e0 \u00e9valuer la conformit\u00e9 des titulaires d&#039;AMM \u00e0 faible risque aux exigences du GVP, \u00e0 l&#039;aide d&#039;un questionnaire visant \u00e0 d\u00e9terminer la n\u00e9cessit\u00e9 d&#039;une inspection r\u00e9guli\u00e8re. Les titulaires d&#039;AMM \u00e0 faible risque d\u00e9tiennent g\u00e9n\u00e9ralement des m\u00e9dicaments peu susceptibles de g\u00e9n\u00e9rer de nombreux effets ind\u00e9sirables graves et pour lesquels il n&#039;existe aucun indicateur de mauvaise conformit\u00e9 aux exigences du GVP. L&#039;objectif du programme est de garantir un niveau de surveillance appropri\u00e9 pour les titulaires d&#039;AMM pr\u00e9sentant diff\u00e9rents niveaux de risque. L&#039;agence pr\u00e9voit de finaliser les inspections, d&#039;analyser et d&#039;exploiter les r\u00e9sultats afin de d\u00e9terminer si cette approche pourrait \u00eatre appliqu\u00e9e \u00e0 tous les titulaires d&#039;AMM \u00e0 faible risque.<\/p>\n<p class=\"reader-text-block__paragraph\"><strong>D\u00e9claration obligatoire des effets ind\u00e9sirables des m\u00e9dicaments dans les h\u00f4pitaux\u00a0<\/strong>Dans le cadre du programme de gestion des m\u00e9dicaments, GVP planifie, en collaboration avec la DPSC et le Projet de collecte de renseignements (PCR), de d\u00e9terminer le niveau actuel de compr\u00e9hension et de conformit\u00e9 des h\u00f4pitaux canadiens aux exigences de d\u00e9claration des effets ind\u00e9sirables des m\u00e9dicaments en vertu de la Loi Vanessa. Le r\u00f4le de GVP, dans le cadre de ce projet, consistera \u00e0 recueillir des informations sur la documentation actuelle des effets ind\u00e9sirables des m\u00e9dicaments dans les h\u00f4pitaux, la conservation des dossiers, les processus et proc\u00e9dures internes sous-jacents \u00e0 la d\u00e9claration des effets ind\u00e9sirables afin d&#039;identifier les lacunes et les d\u00e9fis en mati\u00e8re de connaissances et d&#039;am\u00e9liorer la conformit\u00e9. Un questionnaire sera envoy\u00e9 \u00e0 tous les \u00e9tablissements de sant\u00e9, tels que d\u00e9finis au paragraphe C.01.020(4), partout au Canada.<\/p>\n<p class=\"reader-text-block__paragraph\"><strong>Programme d&#039;inspection GVP - Mise \u00e0 jour r\u00e9glementaire<\/strong><\/p>\n<p class=\"reader-text-block__paragraph\">L&#039;agence a comment\u00e9 la r\u00e9glementation Agile \u00e0 venir et ses implications pour le programme GVP. Parmi celles-ci\u00a0:<\/p>\n<p class=\"reader-text-block__paragraph\">\u2022 Plans de gestion des risques<\/p>\n<p class=\"reader-text-block__paragraph\">\u2022 Termes et conditions<\/p>\n<p class=\"reader-text-block__paragraph\">Pour soutenir ces r\u00e9glementations agiles, les politiques et les orientations actuellement mises \u00e0 jour au sein du programme comprennent :<\/p>\n<ol>\n<li>Strat\u00e9gie d&#039;inspection des bonnes pratiques de pharmacovigilance (BPP) pour les m\u00e9dicaments (POL-0041)<\/li>\n<li>Lignes directrices sur les bonnes pratiques de pharmacovigilance (GVP) (GUI-0102)<\/li>\n<li>Classification des risques des observations des bonnes pratiques de pharmacovigilance (BPP) (GUI-0063)<\/li>\n<\/ol>\n<p class=\"reader-text-block__paragraph\">Zenith PV, votre partenaire de confiance en mati\u00e8re de services photovolta\u00efques complets, peut organiser un appel t\u00e9l\u00e9phonique avec vous pour vous informer des implications de ces changements pour les activit\u00e9s photovolta\u00efques de votre entreprise. Veuillez nous contacter \u00e0 info@zenithpv.ca.<\/p>","protected":false},"excerpt":{"rendered":"<p>L&#039;inspection GVP de Sant\u00e9 Canada est con\u00e7ue pour \u00e9valuer la conformit\u00e9 des titulaires d&#039;autorisations de mise sur le march\u00e9 \u00e9trangers et locaux aux lignes directrices GVP, afin de garantir qu&#039;un syst\u00e8me ad\u00e9quat est en place pour surveiller l&#039;utilisation s\u00fbre et efficace des m\u00e9dicaments.1 \u00c0 ce titre, l&#039;\u00e9valuation de la conformit\u00e9 est essentielle \u00e0 la continuit\u00e9 des soins et \u00e0 l&#039;am\u00e9lioration des patients.<\/p>","protected":false},"author":1,"featured_media":2816,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[18],"tags":[],"class_list":["post-2807","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-all-articles"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.2 (Yoast SEO v26.8) - 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