Vigilance de\u011ferlendirmesinde olay\u0131n hasta, kullan\u0131c\u0131 veya \u00fc\u00e7\u00fcnc\u00fc ki\u015fi \u00fczerinde \u00f6l\u00fcm ya da ciddi sa\u011fl\u0131k bozulmas\u0131 riski yarat\u0131p yaratmad\u0131\u011f\u0131 incelenmelidir. Kesin k\u00f6k neden bulunmadan \u00f6nce de raporlama y\u00fck\u00fcml\u00fcl\u00fc\u011f\u00fc do\u011fabilir; s\u00fcreler genellikle olaydan haberdar olma tarihiyle ili\u015fkilidir. Firma, \u015fikayet kayd\u0131, olay de\u011ferlendirmesi, t\u0131bbi de\u011ferlendirme, risk analizi etkisi, CAPA\/FSCA karar\u0131 ve yetkili otorite bildirimi aras\u0131ndaki ba\u011f\u0131 g\u00f6sterebilmelidir. Ayn\u0131 t\u00fcr olaylarda art\u0131\u015f varsa trend reporting ve PMS\/PSUR g\u00fcncellemesi de de\u011ferlendirilmelidir. Dosyada ayn\u0131 bilgi etiket, IFU, risk analizi, GSPR matrisi ve uygunluk beyan\u0131nda tutarl\u0131 g\u00f6r\u00fcnmelidir.<\/p>","protected":false},"excerpt":{"rendered":"
Vigilance de\u011ferlendirmesinde olay\u0131n hasta, kullan\u0131c\u0131 veya \u00fc\u00e7\u00fcnc\u00fc ki\u015fi \u00fczerinde \u00f6l\u00fcm ya da ciddi sa\u011fl\u0131k bozulmas\u0131 riski yarat\u0131p yaratmad\u0131\u011f\u0131 incelenmelidir. Kesin […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"kkqa_category":[508],"kkqa_letter":[485],"class_list":["post-13715","kkqa_question","type-kkqa_question","status-publish","hentry","kkqa_category-vigilance","kkqa_letter-v"],"_links":{"self":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13715","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question"}],"about":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/types\/kkqa_question"}],"author":[{"embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/comments?post=13715"}],"version-history":[{"count":0,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13715\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/media?parent=13715"}],"wp:term":[{"taxonomy":"kkqa_category","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_category?post=13715"},{"taxonomy":"kkqa_letter","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_letter?post=13715"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}