{"id":23345,"date":"2022-08-03T08:21:40","date_gmt":"2022-08-03T08:21:40","guid":{"rendered":"https:\/\/www.esin.av.tr\/?p=23345"},"modified":"2022-08-03T08:21:40","modified_gmt":"2022-08-03T08:21:40","slug":"saglik-sektorunde-guncel-gelismeler-7","status":"publish","type":"post","link":"https:\/\/www.esin.av.tr\/tr\/2022\/08\/03\/saglik-sektorunde-guncel-gelismeler-7\/","title":{"rendered":"Sa\u011fl\u0131k Sekt\u00f6r\u00fcnde G\u00fcncel Geli\u015fmeler"},"content":{"rendered":"<p><strong><a href=\"https:\/\/podcast.esin.av.tr\/?lang=tr&amp;playing=PFC3606939256?updated=1659449697\" target=\"_blank\" rel=\"noopener\"><img decoding=\"async\" class=\"alignnone  wp-image-18799\" src=\"https:\/\/www.esin.av.tr\/wp-content\/uploads\/2021\/02\/1.png\" alt=\"\" width=\"50\" height=\"50\" srcset=\"https:\/\/www.esin.av.tr\/wp-content\/uploads\/2021\/02\/1.png 186w, https:\/\/www.esin.av.tr\/wp-content\/uploads\/2021\/02\/1-150x150.png 150w\" sizes=\"(max-width: 50px) 100vw, 50px\" \/><\/a>\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 Bu b\u00fcltenimizi podcast olarak da dinleyebilirsiniz!<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p>T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (&#8220;<strong>Kurum<\/strong>&#8220;) ge\u00e7ti\u011fimiz haftalarda kozmetik ve biyosidal \u00fcr\u00fcnlerin piyasa g\u00f6zetimi ve denetimi ile ilgili ikinci \u00e7eyrek sonu\u00e7lar\u0131n\u0131 a\u00e7\u0131klad\u0131, T\u0131bbi Cihaz Klinik Ara\u015ft\u0131rmalar\u0131 Y\u00f6netmeli\u011fi&#8217;ni yay\u0131mlad\u0131 ve \u0130la\u00e7 ve Biyolojik \u00dcr\u00fcnlerin Klinik Ara\u015ft\u0131rmalar\u0131 Hakk\u0131nda Y\u00f6netmelik ile \u0130la\u00e7lar\u0131n G\u00fcvenlili\u011fi Hakk\u0131nda Y\u00f6netmelik&#8217;te de\u011fi\u015fiklik yapt\u0131.<\/p>\n<p>G\u00fcncel geli\u015fmeler \u00f6zelindeki notlar\u0131m\u0131za a\u015fa\u011f\u0131daki linklerden ula\u015fabilirsiniz:<\/p>\n<p><u><a href=\"#tr1\"><strong>Kozmetik ve Biyosidal \u00dcr\u00fcn G\u00fcvenli\u011fi: T\u00fcrkiye G\u00fcvensiz ve Teknik D\u00fczenlemeye Ayk\u0131r\u0131 \u00dcr\u00fcnlerin \u00dczerine Gitmeye Devam Ediyor<\/strong><\/a><br \/>\n<strong><a href=\"#tr2\">\u0130la\u00e7 ve Biyolojik \u00dcr\u00fcnlerin Klinik Ara\u015ft\u0131rmalar\u0131 Hakk\u0131nda Y\u00f6netmelik&#8217;te De\u011fi\u015fiklik<\/a><\/strong><strong><br \/>\n<a href=\"#tr3\">T\u0131bbi Cihaz Klinik Ara\u015ft\u0131rmalar\u0131 Y\u00f6netmeli\u011fi yay\u0131mland\u0131<\/a> <\/strong><br \/>\n<a href=\"#tr4\"><strong>\u0130la\u00e7lar\u0131n G\u00fcvenlili\u011fi Hakk\u0131nda Y\u00f6netmelik&#8217;te De\u011fi\u015fiklik<\/strong><\/a><br \/>\n<\/u><br \/>\n<strong>Kozmetik ve Biyosidal \u00dcr\u00fcn G\u00fcvenli\u011fi: T\u00fcrkiye G\u00fcvensiz ve Teknik D\u00fczenlemeye Ayk\u0131r\u0131 \u00dcr\u00fcnlerin \u00dczerine Gitmeye Devam Ediyor<\/strong><\/p>\n<p><strong>Yeni Geli\u015fme<\/strong><\/p>\n<p>Kurum, ge\u00e7ti\u011fimiz g\u00fcnlerde 2022 y\u0131l\u0131n\u0131n Nisan-May\u0131s-Haziran aylar\u0131n\u0131 kapsayan d\u00f6nemde kozmetik ve biyosidal \u00fcr\u00fcnlerin piyasa g\u00f6zetimi ve denetimi ile ilgili ikinci \u00e7eyrek sonu\u00e7lar\u0131n\u0131 a\u00e7\u0131klad\u0131.<\/p>\n<p>Kurum&#8217;un Kozmetik Denetim Dairesi taraf\u0131ndan denetlenen 282 kozmetik \u00fcr\u00fcnden 200 tanesinin teknik d\u00fczenlemeye ayk\u0131r\u0131, 5 tanesinin ise g\u00fcvensiz oldu\u011fu tespit edildi. Sorumlu \u015firketlere toplam 295.000 TL&#8217;lik ceza kesildi.<\/p>\n<p>Kurum&#8217;un Kozmetik Denetim Dairesi taraf\u0131ndan denetlenen 17 tip-1 ve tip-19 biyosidal \u00fcr\u00fcnden 5 tanesinin ruhsats\u0131z, 2 tanesinin ise teknik d\u00fczenlemeye ayk\u0131r\u0131 oldu\u011fu tespit edildi. Sorumlu \u015firketlere toplam 214.480 TL&#8217;lik ceza kesildi.<\/p>\n<p><strong>Sonu\u00e7lar Ne Anlama Geliyor?<\/strong><\/p>\n<p>2022 y\u0131l\u0131n\u0131n birinci \u00e7eyrek sonu\u00e7lar\u0131 ile k\u0131yasland\u0131\u011f\u0131nda, denetlenen kozmetik \u00fcr\u00fcn say\u0131s\u0131nda \u00f6nemli bir d\u00fc\u015f\u00fc\u015f ve teknik d\u00fczenlemeye ayk\u0131r\u0131 \u00fcr\u00fcn say\u0131s\u0131nda art\u0131\u015f dikkat \u00e7ekiyor. Uygulanan toplam ceza tutarlar\u0131nda ise bir d\u00fc\u015f\u00fc\u015f g\u00f6r\u00fcl\u00fcyor.<\/p>\n<p>Tip-1 ve tip-19 biyosidal \u00fcr\u00fcnlerin 2022 y\u0131l\u0131 birinci \u00e7eyrek sonu\u00e7lar\u0131 ile k\u0131yasland\u0131\u011f\u0131nda, denetlenen \u00fcr\u00fcn say\u0131s\u0131 ve teknik d\u00fczenlemeye ayk\u0131r\u0131 ve ruhsats\u0131z \u00fcr\u00fcn say\u0131s\u0131nda bir d\u00fc\u015f\u00fc\u015f g\u00f6r\u00fcl\u00fcyor. Bu kapsamda uygulanan para cezalar\u0131nda da \u00f6nemli bir azalma dikkat \u00e7ekiyor.<\/p>\n<p>Kozmetik \u00fcr\u00fcnlerin 2022 y\u0131l\u0131 ikinci \u00e7eyrek denetim verilerine <a href=\"https:\/\/urldefense.com\/v3\/__https:\/esinxchange.com\/collect\/click.aspx?u=YjFIZDRPY253ckh1MTIrMWdjNmtENlZXZW5CSVVnMm5VVnBLMkFjSFFPeU5wdDExeElpaWlQdzhzSTk3MGRxSStFN2JnaVk3bGthTU40dy8zeFpYOXVaWHFJRzdTSURHLzFoR3huYXoyUU41aENzb2luc29MNUQxcVIvVFFHMUkyS29kNExnakFuVExQQ09rSWdSS0draStoelJxWmFOaTk0RWZySU5tVEZFSDc1bzJ6MjRUYkVEN1M4R0JVdXpZ&amp;rh=ff0095e749f74887b91b169803499fe1260fa6ff__;!!Hj9Y_P0nvg!Uw6xdiKw3juEulPJRucPIVfdRmoVuIlkr9qGi9HT9xRvG9dYQ8fCAtQGQ9sYqsTw8CR9YYBI8bkTQUgCIL1XKQwISw$\">buradan<\/a>, tip-1 ve tip-19 biyosidal \u00fcr\u00fcnlerin 2022 y\u0131l\u0131 ikinci \u00e7eyrek denetim verilerine <a href=\"https:\/\/urldefense.com\/v3\/__https:\/esinxchange.com\/collect\/click.aspx?u=YjFIZDRPY253ckh1MTIrMWdjNmtENlZXZW5CSVVnMm5VVnBLMkFjSFFPeU5wdDExeElpaWlQdzhzSTk3MGRxSStFN2JnaVk3bGtaZXF5eFozQkExRnNGTWpCbzRyVDBacUlKOFErZ24xcXRXajB0MTFma0FGaUFzSnF3ZmtMbFZQUFQrK0lvK3BYbG8vS01OWWhuVXJBalpUSGlrUXEyWmFlM2tSQ1NDdzR1ZHBHWjN3MEgvRU0vd3NEeEd3Vjd1Qmg5MmRNK2NNRitTTFowcWc2di9wdz09&amp;rh=ff0095e749f74887b91b169803499fe1260fa6ff__;!!Hj9Y_P0nvg!Uw6xdiKw3juEulPJRucPIVfdRmoVuIlkr9qGi9HT9xRvG9dYQ8fCAtQGQ9sYqsTw8CR9YYBI8bkTQUgCIL12UE_ouA$\">buradan <\/a>ula\u015fabilirsiniz.<\/p>\n<p><strong>\u0130la\u00e7 ve Biyolojik \u00dcr\u00fcnlerin Klinik Ara\u015ft\u0131rmalar\u0131 Hakk\u0131nda Y\u00f6netmelik&#8217;te De\u011fi\u015fiklik<\/strong><\/p>\n<p><strong>Yeni Geli\u015fme<\/strong><\/p>\n<p>Kurum taraf\u0131ndan 6 Temmuz 2022 tarihinde yay\u0131mlanarak y\u00fcr\u00fcrl\u00fc\u011fe giren \u0130la\u00e7 ve Biyolojik \u00dcr\u00fcnlerin Klinik Ara\u015ft\u0131rmalar\u0131 Hakk\u0131nda Y\u00f6netmelik&#8217;te De\u011fi\u015fiklik Yap\u0131lmas\u0131na Dair Y\u00f6netmelik ile\u00a0 \u0130la\u00e7 ve Biyolojik \u00dcr\u00fcnlerin Klinik Ara\u015ft\u0131rmalar\u0131 Hakk\u0131nda Y\u00f6netmelik&#8217;e yeni tan\u0131mlar eklenerek\u00a0 genel esaslar, ara\u015ft\u0131rmaya ili\u015fkin yeni ba\u015fvurular, istisnai durumdaki ara\u015ft\u0131rmalar d\u00fczenlenmi\u015f ve\u00a0 yapt\u0131r\u0131mlar, denetimler ile \u00e7e\u015fitli usul ve esaslarda de\u011fi\u015fiklik yap\u0131lm\u0131\u015ft\u0131r.<\/p>\n<p>Y\u00f6netmelik&#8217;e <a href=\"https:\/\/urldefense.com\/v3\/__https:\/esinxchange.com\/collect\/click.aspx?u=YjFIZDRPY253ckh1MTIrMWdjNmtENlZXZW5CSVVnMm5VVnBLMkFjSFFPek02N3ZTZmNwZjFJb1pvaXBxODlXMHBtWUtYQW1aM2ZWRFFzTUVEQ0Q2dlQ3NUV3VWZGWWNlT3FQN0IwV0dxVG1VVms3WDhXb3E5dz09&amp;rh=ff0095e749f74887b91b169803499fe1260fa6ff__;!!Hj9Y_P0nvg!Uw6xdiKw3juEulPJRucPIVfdRmoVuIlkr9qGi9HT9xRvG9dYQ8fCAtQGQ9sYqsTw8CR9YYBI8bkTQUgCIL21UmytwA$\">buradan <\/a>ula\u015fabilirsiniz.<\/p>\n<p><strong>Ne De\u011fi\u015fecek?<\/strong><\/p>\n<p>Y\u00f6netmelik kapsam\u0131nda getirilen ba\u015fl\u0131ca de\u011fi\u015fiklikler a\u015fa\u011f\u0131daki gibidir:<\/p>\n<p><em>Genel<\/em><\/p>\n<ul>\n<li>Y\u00f6netmelik&#8217;e faaliyet izin belgesi, izleme, koordinat\u00f6r merkez, sa\u011fl\u0131k meslek mensubu terimlerinin tan\u0131mlar\u0131 eklenmi\u015ftir. Bu kapsamda, Faz 1 klinik ara\u015ft\u0131rmalar\u0131n\u0131n ve biyoyararlan\u0131m\/biyoe\u015fde\u011ferlik \u00e7al\u0131\u015fmalar\u0131n\u0131n klinik ve\/veya biyoanalitik k\u0131s\u0131mlar\u0131n\u0131n y\u00fcr\u00fct\u00fcld\u00fc\u011f\u00fc merkezler i\u00e7in Kurum taraf\u0131ndan izin belgesi verilmesi \u00f6ng\u00f6r\u00fclm\u00fc\u015ft\u00fcr.<\/li>\n<li>Klinik ara\u015ft\u0131rma yap\u0131lacak merkezlerde Kurum taraf\u0131ndan yap\u0131lacak denetimler ve de\u011ferlendirmeler sonucunda ilgili mevzuat h\u00fck\u00fcmlerinin kar\u015f\u0131lanmas\u0131 halinde faaliyet izin belgesi d\u00fczenlenecektir.<\/li>\n<\/ul>\n<p><em>Klinik Ara\u015ft\u0131rmalar<\/em><\/p>\n<ul>\n<li>Ara\u015ft\u0131rma ba\u015fvurular\u0131, destekleyici taraf\u0131ndan g\u00f6revlendirilecek T\u00fcrkiye&#8217;de ikamet eden s\u00f6zle\u015fmeli ara\u015ft\u0131rma kurulu\u015fu taraf\u0131ndan etik kurula veya Kurum&#8217;a yap\u0131lacakt\u0131r. T\u00fcrkiye&#8217;de yerle\u015fik temsilcisi bulunmayan destekleyici, ba\u015fvurular\u0131, T\u00fcrkiye&#8217;de ikamet eden bir s\u00f6zle\u015fmeli ara\u015ft\u0131rma kurulu\u015fu arac\u0131l\u0131\u011f\u0131 ile yapmak zorundad\u0131r.<\/li>\n<li>Ba\u015fvuru, \u0130yi Klinik Uygulamalar\u0131 K\u0131lavuzu ve Kurum&#8217;un ba\u015fvuruya ili\u015fkin k\u0131lavuzlar\u0131 \u00e7er\u00e7evesinde, Kurum&#8217;un internet sitesinde yay\u0131mlanan \u00fcst yaz\u0131 \u00f6rnekleri, ba\u015fvuru formu ve di\u011fer formlar\u0131 ile elektronik olarak yap\u0131lacakt\u0131r.<\/li>\n<li>Ba\u015fvuruda eksik olmamas\u0131 halinde, ba\u015fvuru etik kurul taraf\u0131ndan on iki i\u015f g\u00fcn\u00fc i\u00e7inde, Kurum taraf\u0131ndan yirmi iki i\u015f g\u00fcn\u00fc i\u00e7inde incelenecektir.\u00a0 Y\u00f6netmelik&#8217;te belirtilen hallerde bu s\u00fcre 30 i\u015f g\u00fcn\u00fc uzat\u0131labilecektir. \u0130stisnai durumdaki ara\u015ft\u0131rmalar i\u00e7in bu s\u00fcreler 7 g\u00fcnd\u00fcr.<\/li>\n<li>Ara\u015ft\u0131rmaya kat\u0131lacak g\u00f6n\u00fcll\u00fc ki\u015fi veya kanun\u00ee temsilcileri ara\u015ft\u0131rmaya ba\u015flanmadan \u00f6nce sorumlu ara\u015ft\u0131rmac\u0131 taraf\u0131ndan bilgilendirilebilece\u011fi gibi sorumlu ara\u015ft\u0131rmac\u0131 taraf\u0131ndan g\u00f6revlendirilmi\u015f ara\u015ft\u0131rma ekibinden hekim ya da di\u015f hekimi olan bir ara\u015ft\u0131rmac\u0131 taraf\u0131ndan da bilgilendirilebilecektir.<\/li>\n<li>Klinik ara\u015ft\u0131rmalarda onay ve izin gerektiren de\u011fi\u015fikliklerde etik kurul onay\u0131 olmayan de\u011fi\u015fikliklerin uygulanmas\u0131na Kurum izin veremeyecektir.<\/li>\n<li>Ara\u015ft\u0131rman\u0131n ba\u015flama, ilk g\u00f6n\u00fcll\u00fc ilk vizit ve g\u00f6n\u00fcll\u00fc al\u0131m\u0131 sonlan\u0131m tarihleri ger\u00e7ekle\u015fti\u011fi tarihten itibaren on be\u015f g\u00fcn i\u00e7erisinde etik kurula ve Kurum&#8217;a bildirilir. Ayr\u0131ca, Ara\u015ft\u0131rman\u0131n t\u00fcm merkezlerde sona erdirilmesinden itibaren bir y\u0131l i\u00e7erisinde klinik ara\u015ft\u0131rma sonu\u00e7 raporunun \u00f6zetinin ve bu \u00f6zetin g\u00f6n\u00fcll\u00fclerin anlayabilece\u011fi \u015fekilde olu\u015fturulmu\u015f halinin etik kurula ve Kurum&#8217;a bildirilmesi gerekmektedir.<\/li>\n<li>Ara\u015ft\u0131rma yapmak amac\u0131yla imal veya ithal edilen \u00fcr\u00fcnlerin her serisine ait numuneler ile bunlara ait bilgi ve belgeler ile ara\u015ft\u0131rma ile ilgili kay\u0131tlar\u0131n saklanaca\u011f\u0131 asgari s\u00fcre be\u015f y\u0131ldan on d\u00f6rt y\u0131la \u00e7\u0131kar\u0131lm\u0131\u015ft\u0131r.<\/li>\n<\/ul>\n<p><em>Yapt\u0131r\u0131mlar ve Denetimler<\/em><\/p>\n<ul>\n<li>Y\u00f6netmelik&#8217;e eklenen ilave tedbirler maddesi kapsam\u0131nda, etkilenebilir pop\u00fclasyona dahil ki\u015filerin korunmas\u0131 i\u00e7in Kurum taraf\u0131ndan gerekti\u011fi takdirde ek tedbirlere ba\u015fvurulabilecektir.<\/li>\n<li>Kurum, g\u00f6n\u00fcll\u00fclerin g\u00fcvenli\u011fi veya sa\u011fl\u0131\u011f\u0131n\u0131n risk alt\u0131nda olmas\u0131 ve ba\u015fvuru ve bildirim gerekliliklerinin yerine getirilmemesi gibi hallerde ara\u015ft\u0131rmaya ait iznini iptal edip ara\u015ft\u0131rmay\u0131 sonland\u0131rabilir, ara\u015ft\u0131rmay\u0131 durdurabilir veya ara\u015ft\u0131rmada de\u011fi\u015fiklik yap\u0131lmas\u0131n\u0131 talep edebilecektir.<\/li>\n<\/ul>\n<p>Ara\u015ft\u0131rmalara ili\u015fkin her t\u00fcrl\u00fc hukuki ve mali sorumlulu\u011fun destekleyici, s\u00f6zle\u015fmeli ara\u015ft\u0131rma kurulu\u015fu ve ara\u015ft\u0131rma ekibine ait oldu\u011fu a\u00e7\u0131k\u00e7a d\u00fczenlenmi\u015ftir.<\/p>\n<p><strong>T\u0131bbi Cihaz Klinik Ara\u015ft\u0131rmalar\u0131 Y\u00f6netmeli\u011fi yay\u0131mland\u0131<\/strong><\/p>\n<p><strong>Yeni Geli\u015fme<\/strong><\/p>\n<p>Kurum, 8 Temmuz 2022 tarihinde T\u0131bbi Cihaz Klinik Ara\u015ft\u0131rmalar\u0131 Y\u00f6netmeli\u011fi&#8217;ni yay\u0131mlad\u0131. Y\u00f6netmelik, piyasaya arz sonras\u0131 \u00e7al\u0131\u015fmalar\u0131 ve t\u0131bbi cihaz klinik ara\u015ft\u0131rmalar\u0131 ile bu ara\u015ft\u0131rmalara kat\u0131lan g\u00f6n\u00fcll\u00fclerin haklar\u0131n\u0131n korunmas\u0131na dair usul ve esaslar\u0131 d\u00fczenlemektir.<\/p>\n<p>Y\u00f6netmelik&#8217;e <a href=\"https:\/\/urldefense.com\/v3\/__https:\/esinxchange.com\/collect\/click.aspx?u=YjFIZDRPY253ckh1MTIrMWdjNmtENlZXZW5CSVVnMm5VVnBLMkFjSFFPek02N3ZTZmNwZjFJb1pvaXBxODlXMHBtWUtYQW1aM2ZWRFFzTUVEQ0Q2dlQ3NUV3VWZGWWNlT3FQN0IwV0dxVGt5S04rMkMvTHVBWFAvY3hoK3haV3c=&amp;rh=ff0095e749f74887b91b169803499fe1260fa6ff__;!!Hj9Y_P0nvg!Uw6xdiKw3juEulPJRucPIVfdRmoVuIlkr9qGi9HT9xRvG9dYQ8fCAtQGQ9sYqsTw8CR9YYBI8bkTQUgCIL1cZufG_w$\">buradan <\/a>ula\u015fabilirsiniz.<\/p>\n<p><strong>Ne De\u011fi\u015fecek?<\/strong><\/p>\n<ul>\n<li>Klinik ara\u015ft\u0131rmalar ile ilgili olarak T\u0131bbi Cihaz Y\u00f6netmeli\u011fi&#8217;nde yer alan d\u00fczenlemelere ek olarak T\u0131bbi Cihaz Klinik Ara\u015ft\u0131rmalar\u0131 Y\u00f6netmeli\u011fi uygulanacakt\u0131r. Bu kapsamda, ara\u015ft\u0131rma cihaz\u0131n\u0131n, \u00f6ncelikle insan d\u0131\u015f\u0131 deney ortam\u0131nda veya yeterli say\u0131da deney hayvan\u0131 \u00fczerinde ara\u015ft\u0131r\u0131lm\u0131\u015f olmas\u0131; insan d\u0131\u015f\u0131 deney ortam\u0131nda veya hayvanlar \u00fczerinde yap\u0131lan deneyler sonucunda ula\u015f\u0131lan bilimsel verilerin, ara\u015ft\u0131rma ile var\u0131lmak istenen hedefe ula\u015fmak a\u00e7\u0131s\u0131ndan yeterli kan\u0131t\u0131 sa\u011flamas\u0131 ve g\u00f6n\u00fcll\u00fcye ait germ h\u00fccrelerinin genetik yap\u0131s\u0131n\u0131 bozmamas\u0131 gerekmektedir.<\/li>\n<li>G\u00f6n\u00fcll\u00fclerin ara\u015ft\u0131rmaya kat\u0131l\u0131m\u0131 amac\u0131yla herhangi bir ikna edici te\u015fvikte veya m\u00e2li teklifte bulunulamasa da ara\u015ft\u0131rmaya kat\u0131l\u0131m ile ortaya \u00e7\u0131kacak masraflar ile sa\u011fl\u0131kl\u0131 g\u00f6n\u00fcll\u00fclerin \u00e7al\u0131\u015fma g\u00fcn\u00fc kayb\u0131ndan do\u011fan gelirden yoksunluk ara\u015ft\u0131rma b\u00fct\u00e7esinde belirtilerek kar\u015f\u0131lanabilecektir.<\/li>\n<li>CE i\u015fareti ta\u015f\u0131yan ve t\u0131bbi cihaz\u0131n imalat\u00e7\u0131s\u0131 taraf\u0131ndan belirtilen kullan\u0131m amac\u0131 do\u011frultusunda yap\u0131lan t\u0131bbi cihaz klinik ara\u015ft\u0131rmalar\u0131nda etik kurulun fayda-risk oran\u0131n\u0131 uygun g\u00f6rd\u00fc\u011f\u00fc ara\u015ft\u0131rmalar hari\u00e7 t\u00fcm t\u0131bbi cihaz klinik ara\u015ft\u0131rmalar\u0131nda g\u00f6n\u00fcll\u00fclere sigorta yap\u0131lmas\u0131 \u015fartt\u0131r.<\/li>\n<li>Etkilenebilir pop\u00fclasyonlarda klinik ara\u015ft\u0131rmalar, T\u0131bbi Cihaz Y\u00f6netmeli\u011fi&#8217;nde \u00f6ng\u00f6r\u00fclen izin, onay ve bilgilendirmeye ili\u015fkin d\u00fczenlemeler \u00e7er\u00e7evesinde y\u00fcr\u00fct\u00fclebilecektir.<\/li>\n<li>EUDAMED i\u015flevsellik tarihine kadar klinik ara\u015ft\u0131rma ba\u015fvurular\u0131 ile piyasa arz sonras\u0131 \u00e7al\u0131\u015fmalar i\u00e7in T\u0131bbi Cihaz Y\u00f6netmeli\u011fi&#8217;nin ilgili maddeleri uygulama alan\u0131 bulacakt\u0131r. Klinik ara\u015ft\u0131rman\u0131n sona ermesi, ge\u00e7ici durdurulmas\u0131, erken sonland\u0131r\u0131lmas\u0131na veya advers olaylara ili\u015fkin raporlamalar T\u0131bbi Cihaz Y\u00f6netmeli\u011fi&#8217;nin ilgili maddelerine uygun olarak yerine getirilecektir.<\/li>\n<li>Klinik ara\u015ft\u0131rman\u0131n sponsorunun, g\u00f6n\u00fcll\u00fclerin g\u00fcvenli\u011fi, sa\u011fl\u0131\u011f\u0131 veya haklar\u0131 \u00fczerinde ya da ara\u015ft\u0131rmadan elde edilen klinik verilerin tutarl\u0131l\u0131\u011f\u0131 veya g\u00fcvenilirli\u011fi \u00fczerindeki \u00f6nemli de\u011fi\u015fiklikler i\u00e7in yap\u0131lmak istenen de\u011fi\u015fikliklerin mahiyeti ve nedenleri ile birlikte Kurum&#8217;a yapaca\u011f\u0131 ba\u015fvuru ile izin almas\u0131 gerekmektedir.<\/li>\n<li>CE i\u015fareti ta\u015f\u0131mayan klinik ara\u015ft\u0131rma ama\u00e7l\u0131 cihazlar\u0131n ilgili ara\u015ft\u0131rmalarda kullan\u0131lmas\u0131 amac\u0131yla \u00fclkeye getirilebilmesi i\u00e7in sponsor taraf\u0131ndan Kurum&#8217;dan izin al\u0131nmas\u0131 gerekmektedir.<\/li>\n<li>Sponsor, yaz\u0131l\u0131 s\u00f6zle\u015fme yap\u0131lmak kayd\u0131yla kendi g\u00f6revlerinin bir k\u0131sm\u0131n\u0131 bilimsel esaslara ve iyi klinik uygulamalar\u0131na uygun \u015fekilde \u00e7al\u0131\u015fan s\u00f6zle\u015fmeli ara\u015ft\u0131rma kurulu\u015funa devredebilecek olup s\u00f6z konusu devir, sponsorun hukuk\u00ee ve ceza\u00ee sorumlulu\u011funu ortadan kald\u0131rmayacakt\u0131r.<\/li>\n<li>Kurum; yurt i\u00e7inde veya yurt d\u0131\u015f\u0131nda y\u00fcr\u00fct\u00fclen ara\u015ft\u0131rmalar\u0131, ara\u015ft\u0131rmalar\u0131n yap\u0131ld\u0131\u011f\u0131 yerleri ve ara\u015ft\u0131rmalar\u0131 y\u00fcr\u00fcten t\u00fcm taraflar\u0131 \u00f6nceden haber vererek veya haber vermeden denetleyebilecek olup ayk\u0131r\u0131l\u0131k halinde T\u00fcrk Ceza Kanunu ve ilgili di\u011fer mevzuat h\u00fck\u00fcmleri uygulanacakt\u0131r.<\/li>\n<\/ul>\n<p><strong>\u0130la\u00e7lar\u0131n G\u00fcvenlili\u011fi Hakk\u0131nda Y\u00f6netmelik&#8217;te De\u011fi\u015fiklik<\/strong><\/p>\n<p><strong>Yeni Geli\u015fme<\/strong><\/p>\n<p>Kurum taraf\u0131ndan 21 Temmuz 2022 tarihinde yay\u0131mlanarak y\u00fcr\u00fcrl\u00fc\u011fe giren \u0130la\u00e7lar\u0131n G\u00fcvenlili\u011fi Hakk\u0131nda Y\u00f6netmelikte De\u011fi\u015fiklik Yap\u0131lmas\u0131na Dair Y\u00f6netmelik ile \u0130la\u00e7lar\u0131n G\u00fcvenlili\u011fi Hakk\u0131nda Y\u00f6netmelik&#8217;te ila\u00e7 (be\u015feri t\u0131bbi \u00fcr\u00fcn) tan\u0131m\u0131nda, risk y\u00f6netim plan\u0131n\u0131n g\u00fcncellenmesi ve ruhsat sahibinin yapmas\u0131 gereken bildirimlere ili\u015fkin d\u00fczenlemeler ile idari yapt\u0131r\u0131mlarda de\u011fi\u015fiklik yap\u0131ld\u0131.<\/p>\n<p>Y\u00f6netmelik&#8217;e <a href=\"https:\/\/urldefense.com\/v3\/__https:\/esinxchange.com\/collect\/click.aspx?u=YjFIZDRPY253ckh1MTIrMWdjNmtENlZXZW5CSVVnMm5VVnBLMkFjSFFPek02N3ZTZmNwZjFJb1pvaXBxODlXMHBtWUtYQW1aM2ZWRFFzTUVEQ0Q2dlQ3NUV3VWZGWWNlSmRFdTJyay9vSHJWbmE5d2ttZUlJRFBscGVVWnVUdUY=&amp;rh=ff0095e749f74887b91b169803499fe1260fa6ff__;!!Hj9Y_P0nvg!Uw6xdiKw3juEulPJRucPIVfdRmoVuIlkr9qGi9HT9xRvG9dYQ8fCAtQGQ9sYqsTw8CR9YYBI8bkTQUgCIL1i-j0YHw$\">buradan <\/a>ula\u015fabilirsiniz.<\/p>\n<p><strong>Ne De\u011fi\u015fecek?<\/strong><\/p>\n<p>Y\u00f6netmelik kapsam\u0131nda getirilen ba\u015fl\u0131ca de\u011fi\u015fiklikler a\u015fa\u011f\u0131daki gibidir:<\/p>\n<ul>\n<li>\u0130la\u00e7 (be\u015feri t\u0131bbi \u00fcr\u00fcn) terimi kapsam\u0131nda t\u0131bbi te\u015fhis amac\u0131yla kullan\u0131lan madde veya maddeler kombinasyonunun da yer ald\u0131\u011f\u0131 a\u00e7\u0131k\u00e7a d\u00fczenlenmi\u015ftir.<\/li>\n<li>Ruhsat sahiplerinin advers reaksiyon raporlar\u0131nda biyolojik ve biyoteknolojik \u00fcr\u00fcnlerin seri numaralar\u0131na da yer vermeleri gerekecektir.<\/li>\n<li>Risk y\u00f6netim plan\u0131n\u0131n g\u00fcncellenmesi halinde\u00a0 g\u00fcncel plan, ayr\u0131 bir versiyon numaras\u0131 ve tarih ile ruhsat sahibi taraf\u0131ndan ar\u015fivlenecek ve \u00a0yap\u0131lan g\u00fcncellemelerin il\u00e2ve farmakovijilans veya risk minimizasyon faaliyeti ya da mevcut faaliyetlerde de\u011fi\u015fiklik gerektirmesi halinde derhal Kurum&#8217;a sunulacakt\u0131r.<\/li>\n<li>Ruhsat sahibi, yarar\/risk de\u011ferlendirme raporlar\u0131n\u0131 T\u00fcrkiye&#8217;de ruhsat ald\u0131ktan sonra Avrupa Birli\u011fi referans tarih ve sunum s\u0131kl\u0131klar\u0131 listesi ile uyumlu olarak haz\u0131rlayacakt\u0131r. \u0130lac\u0131n etkin maddesinin bu listede yer almamas\u0131 durumunda yarar\/risk de\u011ferlendirme raporlar\u0131, y\u00f6netmelikte \u00f6ng\u00f6r\u00fclen s\u0131kl\u0131kta Kurum&#8217;a sunulacakt\u0131r. Ruhsat sahibinin, periyodik yarar\/risk de\u011ferlendirme raporlar\u0131n\u0131, ila\u00e7lar\u0131n ruhsat ge\u00e7erlilik s\u00fcresinin uzat\u0131lmas\u0131 s\u0131ras\u0131nda Be\u015feri T\u0131bbi \u00dcr\u00fcnler Ruhsatland\u0131rma Y\u00f6netmeli\u011fi do\u011frultusunda Kurum&#8217;a sunmas\u0131 gerekmektedir.<\/li>\n<li>Kurum taraf\u0131ndan verilen s\u00fcre i\u00e7inde ayk\u0131r\u0131l\u0131\u011f\u0131 gidermeyen s\u00f6zle\u015fmeli farmakovijilans hizmet kurulu\u015flar\u0131 i\u00e7in ayk\u0131r\u0131l\u0131\u011f\u0131n niteli\u011fine ba\u011fl\u0131 olarak faaliyetlerin k\u0131s\u0131tlanmas\u0131, izin belgesinin ask\u0131ya al\u0131nmas\u0131 veya iptali idari yapt\u0131r\u0131mlar\u0131 uygulanabilecektir. Ruhsat sahipleri i\u00e7inse ayk\u0131r\u0131l\u0131\u011f\u0131n niteli\u011fine ba\u011fl\u0131 olarak ila\u00e7 takip sistemi bildirimi yap\u0131lmas\u0131n\u0131n engellenmesi, \u00fcr\u00fcn hareketlerinin durdurulmas\u0131, ilac\u0131n ruhsat\u0131n\u0131n ask\u0131ya al\u0131nmas\u0131 veya iptali s\u00f6z konusu olabilecektir.<\/li>\n<\/ul>\n<p><strong>Sonu\u00e7<\/strong><\/p>\n<p>Kurum sa\u011fl\u0131k sekt\u00f6r\u00fcnde faaliyet g\u00f6steren \u015firketlere rehberlik etmeye devam etmektedir. Sa\u011fl\u0131k sekt\u00f6r\u00fcnde faaliyet g\u00f6steren t\u00fcm ilgili \u015firketler, Kurum&#8217;un duyurular\u0131n\u0131 yak\u0131ndan takip etmeli ve mevzuatta yer alan y\u00fck\u00fcml\u00fcl\u00fcklerini Kurum&#8217;un y\u00f6nlendirmeleri do\u011frultusunda yerine getirmelidir.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 Bu b\u00fcltenimizi podcast olarak da dinleyebilirsiniz! &nbsp; T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_stopmodifiedupdate":false,"_modified_date":"","footnotes":""},"categories":[120],"tags":[92],"class_list":["post-23345","post","type-post","status-publish","format-standard","hentry","category-legal-alerts","tag-healthcare-tr"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Sa\u011fl\u0131k Sekt\u00f6r\u00fcnde G\u00fcncel Geli\u015fmeler<\/title>\n<meta name=\"description\" content=\"\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 Bu b\u00fcltenimizi podcast olarak da dinleyebilirsiniz! &nbsp; T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (&quot;Kurum&quot;) ge\u00e7ti\u011fimiz haftalarda kozmetik ve\" \/>\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.esin.av.tr\/tr\/2022\/08\/03\/saglik-sektorunde-guncel-gelismeler-7\/\" \/>\n<meta property=\"og:locale\" content=\"tr_TR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Sa\u011fl\u0131k Sekt\u00f6r\u00fcnde G\u00fcncel Geli\u015fmeler\" \/>\n<meta property=\"og:description\" content=\"\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 Bu b\u00fcltenimizi podcast olarak da dinleyebilirsiniz! &nbsp; T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (&quot;Kurum&quot;) ge\u00e7ti\u011fimiz haftalarda kozmetik ve\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.esin.av.tr\/tr\/2022\/08\/03\/saglik-sektorunde-guncel-gelismeler-7\/\" \/>\n<meta property=\"og:site_name\" content=\"Esin Avukatl\u0131k Ortakl\u0131\u011f\u0131\" \/>\n<meta property=\"article:published_time\" content=\"2022-08-03T08:21:40+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.esin.av.tr\/wp-content\/uploads\/2021\/02\/1.png\" \/>\n<meta name=\"author\" content=\"R\u0131dvan Konrat\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"R\u0131dvan Konrat\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"11 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.esin.av.tr\/tr\/2022\/08\/03\/saglik-sektorunde-guncel-gelismeler-7\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.esin.av.tr\/tr\/2022\/08\/03\/saglik-sektorunde-guncel-gelismeler-7\/\"},\"author\":{\"name\":\"R\u0131dvan Konrat\",\"@id\":\"https:\/\/www.esin.av.tr\/tr\/#\/schema\/person\/42c8e616aab56b8622fa365ad63282ae\"},\"headline\":\"Sa\u011fl\u0131k Sekt\u00f6r\u00fcnde G\u00fcncel Geli\u015fmeler\",\"datePublished\":\"2022-08-03T08:21:40+00:00\",\"dateModified\":\"2022-08-03T08:21:40+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.esin.av.tr\/tr\/2022\/08\/03\/saglik-sektorunde-guncel-gelismeler-7\/\"},\"wordCount\":2230,\"publisher\":{\"@id\":\"https:\/\/www.esin.av.tr\/tr\/#organization\"},\"image\":{\"@id\":\"https:\/\/www.esin.av.tr\/tr\/2022\/08\/03\/saglik-sektorunde-guncel-gelismeler-7\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.esin.av.tr\/wp-content\/uploads\/2021\/02\/1.png\",\"keywords\":[\"Sa\u011fl\u0131k Hukuku\"],\"articleSection\":[\"Hukuk B\u00fcltenleri\"],\"inLanguage\":\"tr\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.esin.av.tr\/tr\/2022\/08\/03\/saglik-sektorunde-guncel-gelismeler-7\/\",\"url\":\"https:\/\/www.esin.av.tr\/tr\/2022\/08\/03\/saglik-sektorunde-guncel-gelismeler-7\/\",\"name\":\"Sa\u011fl\u0131k Sekt\u00f6r\u00fcnde G\u00fcncel Geli\u015fmeler\",\"isPartOf\":{\"@id\":\"https:\/\/www.esin.av.tr\/tr\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/www.esin.av.tr\/tr\/2022\/08\/03\/saglik-sektorunde-guncel-gelismeler-7\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/www.esin.av.tr\/tr\/2022\/08\/03\/saglik-sektorunde-guncel-gelismeler-7\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.esin.av.tr\/wp-content\/uploads\/2021\/02\/1.png\",\"datePublished\":\"2022-08-03T08:21:40+00:00\",\"dateModified\":\"2022-08-03T08:21:40+00:00\",\"description\":\"\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 Bu b\u00fcltenimizi podcast olarak da dinleyebilirsiniz! &nbsp; T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (\\\"Kurum\\\") ge\u00e7ti\u011fimiz haftalarda kozmetik ve\",\"breadcrumb\":{\"@id\":\"https:\/\/www.esin.av.tr\/tr\/2022\/08\/03\/saglik-sektorunde-guncel-gelismeler-7\/#breadcrumb\"},\"inLanguage\":\"tr\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.esin.av.tr\/tr\/2022\/08\/03\/saglik-sektorunde-guncel-gelismeler-7\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"tr\",\"@id\":\"https:\/\/www.esin.av.tr\/tr\/2022\/08\/03\/saglik-sektorunde-guncel-gelismeler-7\/#primaryimage\",\"url\":\"https:\/\/www.esin.av.tr\/wp-content\/uploads\/2021\/02\/1.png\",\"contentUrl\":\"https:\/\/www.esin.av.tr\/wp-content\/uploads\/2021\/02\/1.png\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.esin.av.tr\/tr\/2022\/08\/03\/saglik-sektorunde-guncel-gelismeler-7\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/www.esin.av.tr\/tr\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Sa\u011fl\u0131k Sekt\u00f6r\u00fcnde G\u00fcncel Geli\u015fmeler\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.esin.av.tr\/tr\/#website\",\"url\":\"https:\/\/www.esin.av.tr\/tr\/\",\"name\":\"Esin Avukatl\u0131k Ortakl\u0131\u011f\u0131\",\"description\":\"\",\"publisher\":{\"@id\":\"https:\/\/www.esin.av.tr\/tr\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.esin.av.tr\/tr\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"tr\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/www.esin.av.tr\/tr\/#organization\",\"name\":\"Esin Avukatl\u0131k Ortakl\u0131\u011f\u0131\",\"url\":\"https:\/\/www.esin.av.tr\/tr\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"tr\",\"@id\":\"https:\/\/www.esin.av.tr\/tr\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/www.esin.av.tr\/wp-content\/uploads\/2021\/09\/esin-2.jpg\",\"contentUrl\":\"https:\/\/www.esin.av.tr\/wp-content\/uploads\/2021\/09\/esin-2.jpg\",\"width\":800,\"height\":460,\"caption\":\"Esin Avukatl\u0131k Ortakl\u0131\u011f\u0131\"},\"image\":{\"@id\":\"https:\/\/www.esin.av.tr\/tr\/#\/schema\/logo\/image\/\"}},{\"@type\":\"Person\",\"@id\":\"https:\/\/www.esin.av.tr\/tr\/#\/schema\/person\/42c8e616aab56b8622fa365ad63282ae\",\"name\":\"R\u0131dvan Konrat\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"tr\",\"@id\":\"https:\/\/www.esin.av.tr\/tr\/#\/schema\/person\/image\/\",\"url\":\"https:\/\/secure.gravatar.com\/avatar\/b20c6c583be38ed4e76e32f69fccc676?s=96&d=mm&r=g\",\"contentUrl\":\"https:\/\/secure.gravatar.com\/avatar\/b20c6c583be38ed4e76e32f69fccc676?s=96&d=mm&r=g\",\"caption\":\"R\u0131dvan Konrat\"},\"sameAs\":[\"http:\/\/www.esin.av.tr\"],\"url\":\"https:\/\/www.esin.av.tr\/tr\/author\/rkonrat\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Sa\u011fl\u0131k Sekt\u00f6r\u00fcnde G\u00fcncel Geli\u015fmeler","description":"\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 Bu b\u00fcltenimizi podcast olarak da dinleyebilirsiniz! &nbsp; T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (\"Kurum\") ge\u00e7ti\u011fimiz haftalarda kozmetik ve","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.esin.av.tr\/tr\/2022\/08\/03\/saglik-sektorunde-guncel-gelismeler-7\/","og_locale":"tr_TR","og_type":"article","og_title":"Sa\u011fl\u0131k Sekt\u00f6r\u00fcnde G\u00fcncel Geli\u015fmeler","og_description":"\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 Bu b\u00fcltenimizi podcast olarak da dinleyebilirsiniz! &nbsp; T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (\"Kurum\") ge\u00e7ti\u011fimiz haftalarda kozmetik ve","og_url":"https:\/\/www.esin.av.tr\/tr\/2022\/08\/03\/saglik-sektorunde-guncel-gelismeler-7\/","og_site_name":"Esin Avukatl\u0131k Ortakl\u0131\u011f\u0131","article_published_time":"2022-08-03T08:21:40+00:00","og_image":[{"url":"https:\/\/www.esin.av.tr\/wp-content\/uploads\/2021\/02\/1.png","type":"","width":"","height":""}],"author":"R\u0131dvan Konrat","twitter_card":"summary_large_image","twitter_misc":{"Written by":"R\u0131dvan Konrat","Est. reading time":"11 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.esin.av.tr\/tr\/2022\/08\/03\/saglik-sektorunde-guncel-gelismeler-7\/#article","isPartOf":{"@id":"https:\/\/www.esin.av.tr\/tr\/2022\/08\/03\/saglik-sektorunde-guncel-gelismeler-7\/"},"author":{"name":"R\u0131dvan Konrat","@id":"https:\/\/www.esin.av.tr\/tr\/#\/schema\/person\/42c8e616aab56b8622fa365ad63282ae"},"headline":"Sa\u011fl\u0131k Sekt\u00f6r\u00fcnde G\u00fcncel Geli\u015fmeler","datePublished":"2022-08-03T08:21:40+00:00","dateModified":"2022-08-03T08:21:40+00:00","mainEntityOfPage":{"@id":"https:\/\/www.esin.av.tr\/tr\/2022\/08\/03\/saglik-sektorunde-guncel-gelismeler-7\/"},"wordCount":2230,"publisher":{"@id":"https:\/\/www.esin.av.tr\/tr\/#organization"},"image":{"@id":"https:\/\/www.esin.av.tr\/tr\/2022\/08\/03\/saglik-sektorunde-guncel-gelismeler-7\/#primaryimage"},"thumbnailUrl":"https:\/\/www.esin.av.tr\/wp-content\/uploads\/2021\/02\/1.png","keywords":["Sa\u011fl\u0131k Hukuku"],"articleSection":["Hukuk B\u00fcltenleri"],"inLanguage":"tr"},{"@type":"WebPage","@id":"https:\/\/www.esin.av.tr\/tr\/2022\/08\/03\/saglik-sektorunde-guncel-gelismeler-7\/","url":"https:\/\/www.esin.av.tr\/tr\/2022\/08\/03\/saglik-sektorunde-guncel-gelismeler-7\/","name":"Sa\u011fl\u0131k Sekt\u00f6r\u00fcnde G\u00fcncel Geli\u015fmeler","isPartOf":{"@id":"https:\/\/www.esin.av.tr\/tr\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.esin.av.tr\/tr\/2022\/08\/03\/saglik-sektorunde-guncel-gelismeler-7\/#primaryimage"},"image":{"@id":"https:\/\/www.esin.av.tr\/tr\/2022\/08\/03\/saglik-sektorunde-guncel-gelismeler-7\/#primaryimage"},"thumbnailUrl":"https:\/\/www.esin.av.tr\/wp-content\/uploads\/2021\/02\/1.png","datePublished":"2022-08-03T08:21:40+00:00","dateModified":"2022-08-03T08:21:40+00:00","description":"\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 Bu b\u00fcltenimizi podcast olarak da dinleyebilirsiniz! &nbsp; T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (\"Kurum\") ge\u00e7ti\u011fimiz haftalarda kozmetik ve","breadcrumb":{"@id":"https:\/\/www.esin.av.tr\/tr\/2022\/08\/03\/saglik-sektorunde-guncel-gelismeler-7\/#breadcrumb"},"inLanguage":"tr","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.esin.av.tr\/tr\/2022\/08\/03\/saglik-sektorunde-guncel-gelismeler-7\/"]}]},{"@type":"ImageObject","inLanguage":"tr","@id":"https:\/\/www.esin.av.tr\/tr\/2022\/08\/03\/saglik-sektorunde-guncel-gelismeler-7\/#primaryimage","url":"https:\/\/www.esin.av.tr\/wp-content\/uploads\/2021\/02\/1.png","contentUrl":"https:\/\/www.esin.av.tr\/wp-content\/uploads\/2021\/02\/1.png"},{"@type":"BreadcrumbList","@id":"https:\/\/www.esin.av.tr\/tr\/2022\/08\/03\/saglik-sektorunde-guncel-gelismeler-7\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.esin.av.tr\/tr\/"},{"@type":"ListItem","position":2,"name":"Sa\u011fl\u0131k Sekt\u00f6r\u00fcnde G\u00fcncel Geli\u015fmeler"}]},{"@type":"WebSite","@id":"https:\/\/www.esin.av.tr\/tr\/#website","url":"https:\/\/www.esin.av.tr\/tr\/","name":"Esin Avukatl\u0131k Ortakl\u0131\u011f\u0131","description":"","publisher":{"@id":"https:\/\/www.esin.av.tr\/tr\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.esin.av.tr\/tr\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"tr"},{"@type":"Organization","@id":"https:\/\/www.esin.av.tr\/tr\/#organization","name":"Esin Avukatl\u0131k Ortakl\u0131\u011f\u0131","url":"https:\/\/www.esin.av.tr\/tr\/","logo":{"@type":"ImageObject","inLanguage":"tr","@id":"https:\/\/www.esin.av.tr\/tr\/#\/schema\/logo\/image\/","url":"https:\/\/www.esin.av.tr\/wp-content\/uploads\/2021\/09\/esin-2.jpg","contentUrl":"https:\/\/www.esin.av.tr\/wp-content\/uploads\/2021\/09\/esin-2.jpg","width":800,"height":460,"caption":"Esin Avukatl\u0131k Ortakl\u0131\u011f\u0131"},"image":{"@id":"https:\/\/www.esin.av.tr\/tr\/#\/schema\/logo\/image\/"}},{"@type":"Person","@id":"https:\/\/www.esin.av.tr\/tr\/#\/schema\/person\/42c8e616aab56b8622fa365ad63282ae","name":"R\u0131dvan Konrat","image":{"@type":"ImageObject","inLanguage":"tr","@id":"https:\/\/www.esin.av.tr\/tr\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/b20c6c583be38ed4e76e32f69fccc676?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/b20c6c583be38ed4e76e32f69fccc676?s=96&d=mm&r=g","caption":"R\u0131dvan Konrat"},"sameAs":["http:\/\/www.esin.av.tr"],"url":"https:\/\/www.esin.av.tr\/tr\/author\/rkonrat\/"}]}},"_links":{"self":[{"href":"https:\/\/www.esin.av.tr\/tr\/wp-json\/wp\/v2\/posts\/23345","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.esin.av.tr\/tr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.esin.av.tr\/tr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.esin.av.tr\/tr\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.esin.av.tr\/tr\/wp-json\/wp\/v2\/comments?post=23345"}],"version-history":[{"count":1,"href":"https:\/\/www.esin.av.tr\/tr\/wp-json\/wp\/v2\/posts\/23345\/revisions"}],"predecessor-version":[{"id":23346,"href":"https:\/\/www.esin.av.tr\/tr\/wp-json\/wp\/v2\/posts\/23345\/revisions\/23346"}],"wp:attachment":[{"href":"https:\/\/www.esin.av.tr\/tr\/wp-json\/wp\/v2\/media?parent=23345"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.esin.av.tr\/tr\/wp-json\/wp\/v2\/categories?post=23345"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.esin.av.tr\/tr\/wp-json\/wp\/v2\/tags?post=23345"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}