{"id":7321,"date":"2023-05-23T11:56:46","date_gmt":"2023-05-23T09:56:46","guid":{"rendered":"https:\/\/www.sciencepharma.pl\/?post_type=pharmacovigilance&#038;p=7321"},"modified":"2023-12-19T10:15:01","modified_gmt":"2023-12-19T09:15:01","slug":"system-phv-2","status":"publish","type":"pharmacovigilance","link":"https:\/\/www.sciencepharma.com\/pl\/services\/system-phv-2\/","title":{"rendered":"System PhV"},"content":{"rendered":"\n<h1 class=\"wp-block-heading\">System PhV<\/h1>\n\n\n<p style=\"text-align: justify;\">Outsourcing systemu Pharmacovigilance w SciencePharma to wiele dzia\u0142a\u0144, kt\u00f3rych nasi eksperci podejmuj\u0105 si\u0119 dla Klient\u00f3w w zakresie nadzoru nad bezpiecze\u0144stwem farmakoterapii. Je\u015bli Pa\u0144stwa firma posiada lub chcia\u0142aby wprowadzi\u0107 produkt leczniczy na rynek w Polsce lub innych krajach UE, czy te\u017c poza UE, to zgodnie z prawem jako podmiot odpowiedzialny zobligowani jeste\u015bcie Pa\u0144stwo do implementacji oraz utrzymywania systemu Pharmacovigilance dla swoich produkt\u00f3w leczniczych. Jeste\u015bmy tu, aby Pa\u0144stwu w tym pom\u00f3c.<\/p>\n<p style=\"text-align: justify;\">W zale\u017cno\u015bci od Pa\u0144stwa potrzeb, wsp\u00f3\u0142praca z nami mo\u017ce obejmowa\u0107 pe\u0142en zakres czynno\u015bci Pharmacovigilance b\u0105d\u017a tylko wybrane dzia\u0142ania.<\/p>\n\n\n<p class=\"wp-block-paragraph\"><strong>Nasze us\u0142ugi obejmuj\u0105 mi\u0119dzy innymi:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Przygotowanie i utrzymanie opisu systemu nadzoru nad bezpiecze\u0144stwem stosowania produkt\u00f3w leczniczych (PSMF) oraz opracowanie odpowiednich procedur (SOP) i instrukcji systemowych dla podmiotu odpowiedzialnego;<\/li>\n\n\n\n<li>Implementacj\u0119 systemu Pharmacovigilance, obejmuj\u0105c\u0105 m.in. przygotowanie umowy dotycz\u0105cej wymiany informacji o bezpiecze\u0144stwie produkt\u00f3w leczniczych (SDEA). Dzia\u0142ania te obejmuj\u0105 wsp\u00f3\u0142prac\u0119 z naszym Dzia\u0142em Prawnym;<\/li>\n\n\n\n<li>Zarz\u0105dzanie baz\u0105 z artyku\u0142u 57 (xEVMPD) &#8211; podmiot odpowiedzialny odpowiada za odpowiednie przechowywanie informacji w xEVMPD. Jest te\u017c zobowi\u0105zany aktualizowa\u0107 informacje w bazie w razie zmian porejestracyjnych, transfer\u00f3w pozwole\u0144 oraz otrzymania nowych pozwole\u0144 na dopuszczenie do obrotu. Na szcz\u0119\u015bcie mo\u017cemy Pa\u0144stwu w tym pom\u00f3c. Tak, jak wspieramy wiele innych firm we wprowadzaniu i aktualizacji danych w bazie xEVMPD;<\/li>\n\n\n\n<li>Opracowanie i utrzymywanie Planu Zarz\u0105dzania Ryzykiem (RMP);<\/li>\n\n\n\n<li>Interpretacja dost\u0119pnych informacji regulacyjnych dotycz\u0105cych wymog\u00f3w w zakresie nadzoru nad bezpiecze\u0144stwem farmakoterapii.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>System PhV Outsourcing systemu Pharmacovigilance w SciencePharma to wiele dzia\u0142a\u0144, kt\u00f3rych nasi eksperci podejmuj\u0105 si\u0119 dla Klient\u00f3w w zakresie nadzoru nad bezpiecze\u0144stwem farmakoterapii. Je\u015bli Pa\u0144stwa firma posiada lub chcia\u0142aby wprowadzi\u0107 produkt leczniczy na rynek w Polsce lub innych krajach UE, czy te\u017c poza UE, to zgodnie z prawem jako podmiot odpowiedzialny zobligowani jeste\u015bcie Pa\u0144stwo do [&hellip;]<\/p>\n","protected":false},"featured_media":0,"template":"","meta":{"inline_featured_image":false},"taxonomy":[104,191],"class_list":["post-7321","pharmacovigilance","type-pharmacovigilance","status-publish","hentry","taxonomy-pharmacovigilance-pl-2","taxonomy-system-harmacovigilance-psmf"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>System PhV - SciencePharma<\/title>\n<meta name=\"description\" content=\"Outsourcing systemu PhV to dzia\u0142ania, kt\u00f3rych nasi eksperci podejmuj\u0105 si\u0119 dla Klient\u00f3w w zakresie nadzoru nad bezpiecze\u0144stwem farmakoterapii.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.sciencepharma.com\/pl\/services\/system-phv-2\/\" \/>\n<meta property=\"og:locale\" content=\"pl_PL\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"System PhV - 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