{"id":7324,"date":"2023-05-23T12:00:42","date_gmt":"2023-05-23T10:00:42","guid":{"rendered":"https:\/\/www.sciencepharma.pl\/?post_type=pharmacovigilance&#038;p=7324"},"modified":"2023-07-27T11:13:02","modified_gmt":"2023-07-27T09:13:02","slug":"nadzor-phv-po-otrzymaniu-pozwolenia","status":"publish","type":"pharmacovigilance","link":"https:\/\/www.sciencepharma.com\/pl\/services\/nadzor-phv-po-otrzymaniu-pozwolenia\/","title":{"rendered":"Nadz\u00f3r PhV po otrzymaniu pozwolenia"},"content":{"rendered":"\n<h1 class=\"wp-block-heading\">Nadz\u00f3r PhV po otrzymaniu pozwolenia<\/h1>\n\n\n<p style=\"text-align: justify;\">Wszystkie dzia\u0142ania zwi\u0105zane z nadzorem nad bezpiecze\u0144stwem farmakoterapii potrzebne do uzyskania pozwolenia na dopuszczenie do obrotu s\u0105 oczywi\u015bcie niezb\u0119dne. Warto jednak zauwa\u017cy\u0107, \u017ce jest to dopiero pocz\u0105tek dzia\u0142a\u0144 z zakresu nadzoru Pharmacovigilance, kt\u00f3re musz\u0105 by\u0107 wykonane podczas cyklu \u017cycia produktu. Co wi\u0119cej, dzia\u0142ania po uzyskaniu pozwolenia musz\u0105 by\u0107 wykonane przez podmiot odpowiedzialny w okre\u015blonych terminach, kt\u00f3re nie rzadko s\u0105 bardzo kr\u00f3tkie. Jako SciencePharma proponujemy Pa\u0144stwa firmie outsourcing, dzi\u0119ki czemu wszelkie kwestie Pharmacovigilance b\u0119d\u0105 odpowiednio przez nas wykonane. Jeste\u015bmy tu po to, \u017ceby Pa\u0144stwu pom\u00f3c.<\/p>\n<p style=\"text-align: justify;\">Nasze us\u0142ugi obejmuj\u0105 mi\u0119dzy innymi:<\/p>\n\n\n<ul class=\"wp-block-list\">\n<li>Zarz\u0105dzanie i raportowanie indywidualnych przypadk\u00f3w dzia\u0142a\u0144 niepo\u017c\u0105danych (ICSR) do UE (Eudravigilance) oraz agencji spoza UE;<\/li>\n\n\n\n<li>Wykrywanie i zarz\u0105dzanie sygna\u0142ami;<\/li>\n\n\n\n<li>Wsp\u00f3\u0142praca z lokalnymi punktami kontaktowymi w krajach UE i poza UE;<\/li>\n\n\n\n<li>Us\u0142ug\u0119 Lokalnego przedstawiciela pharmacovigilance;<\/li>\n\n\n\n<li>Przegl\u0105d literatury lokalnej i globalnej;<\/li>\n\n\n\n<li>Przygotowanie raport\u00f3w do cel\u00f3w re-rejestracyjnych (Addendum to Clinical Overview) i raport\u00f3w PSUR<\/li>\n<\/ul>\n\n\n<p style=\"text-align: justify;\">Nasz system Pharmacovigilance jest gotowy aby uwzgl\u0119dni\u0107 w nim Twoj\u0105 firm\u0119. Mamy szerokie do\u015bwiadczenie we wsp\u00f3\u0142pracy z r\u00f3\u017cnymi agencjami europejskimi i pozaeuropejskimi oraz posiadamy wiedz\u0119 o wymaganiach GVP spoza UE. Mo\u017cesz by\u0107 pewien, \u017ce wyb\u00f3r SciencePharma oznacza wsp\u00f3\u0142prac\u0119 z do\u015bwiadczonym i zaufanym partnerem, kt\u00f3ry pokieruje Ci\u0119 dobrze znanymi sobie \u015bcie\u017ckami. Dzi\u0119ki temu, mo\u017cesz liczy\u0107 na raportowanie przypadk\u00f3w na czas nawet do najdalszych zak\u0105tk\u00f3w \u015bwiata. Podobnie w przypadku przygotowywania dokumentacji takiej jak RMP czy PSUR- \u015bwiat Pharmacovigilance nie ma dla nas sekret\u00f3w i granic.<\/p>\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Nadz\u00f3r PhV po otrzymaniu pozwolenia Wszystkie dzia\u0142ania zwi\u0105zane z nadzorem nad bezpiecze\u0144stwem farmakoterapii potrzebne do uzyskania pozwolenia na dopuszczenie do obrotu s\u0105 oczywi\u015bcie niezb\u0119dne. Warto jednak zauwa\u017cy\u0107, \u017ce jest to dopiero pocz\u0105tek dzia\u0142a\u0144 z zakresu nadzoru Pharmacovigilance, kt\u00f3re musz\u0105 by\u0107 wykonane podczas cyklu \u017cycia produktu. Co wi\u0119cej, dzia\u0142ania po uzyskaniu pozwolenia musz\u0105 by\u0107 wykonane przez [&hellip;]<\/p>\n","protected":false},"featured_media":0,"template":"","meta":{"inline_featured_image":false},"taxonomy":[104,120],"class_list":["post-7324","pharmacovigilance","type-pharmacovigilance","status-publish","hentry","taxonomy-pharmacovigilance-pl-2","taxonomy-obsluga-porejestracyjna-pl"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Nadz\u00f3r PhV po otrzymaniu pozwolenia - SciencePharma<\/title>\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\/nadzor-phv-po-otrzymaniu-pozwolenia\/\" \/>\n<meta property=\"og:locale\" content=\"pl_PL\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Nadz\u00f3r PhV po otrzymaniu pozwolenia - SciencePharma\" \/>\n<meta property=\"og:description\" content=\"Nadz\u00f3r PhV po otrzymaniu pozwolenia Wszystkie dzia\u0142ania zwi\u0105zane z nadzorem nad bezpiecze\u0144stwem farmakoterapii potrzebne do uzyskania pozwolenia na dopuszczenie do obrotu s\u0105 oczywi\u015bcie niezb\u0119dne. Warto jednak zauwa\u017cy\u0107, \u017ce jest to dopiero pocz\u0105tek dzia\u0142a\u0144 z zakresu nadzoru Pharmacovigilance, kt\u00f3re musz\u0105 by\u0107 wykonane podczas cyklu \u017cycia produktu. 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