{"id":3783,"date":"2024-11-14T13:44:46","date_gmt":"2024-11-14T10:44:46","guid":{"rendered":"https:\/\/pharmaworlddergi.com\/?p=3783"},"modified":"2024-11-14T13:45:05","modified_gmt":"2024-11-14T10:45:05","slug":"odak-noktamiz-yenilikci-ilac-ve-asilarimizi-en-kisa-surede-ruhsatlandirip-turkiyede-kullanima-sunmak","status":"publish","type":"post","link":"https:\/\/pharmaworlddergi.com\/?p=3783","title":{"rendered":"Odak Noktam\u0131z, Yenilik\u00e7i \u0130la\u00e7 ve A\u015f\u0131lar\u0131m\u0131z\u0131 En K\u0131sa S\u00fcrede Ruhsatland\u0131r\u0131p, T\u00fcrkiye\u2019de Kullan\u0131ma Sunmak"},"content":{"rendered":"\n

1959 y\u0131l\u0131ndan beri T\u00fcrkiye\u2019de a\u015f\u0131, enfeksiyon hastal\u0131klar\u0131, HIV, onkoloji, solunum ve imm\u00fcnoloji ba\u015fta olmak \u00fczere pek \u00e7ok tedavi alan\u0131nda 120\u2019nin \u00fczerinde ruhsatl\u0131 \u00fcr\u00fcnle faaliyet g\u00f6steren GSK\u2019n\u0131n T\u00fcrkiye Ruhsatland\u0131rma Direkt\u00f6r\u00fc Elif Teoman \u00d6zg\u00fcr ile GSK T\u00fcrkiye Ruhsatland\u0131rma Birimi\u2019nin \u00e7al\u0131\u015fmalar\u0131n\u0131 konu\u015ftuk.<\/p>\n\n\n\n

Sizi tan\u0131yabilir miyiz?<\/strong><\/p>\n\n\n

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Ankara \u00dcniversitesi Eczac\u0131l\u0131k Fak\u00fcltesi\u2019nden 2008 y\u0131l\u0131nda mezun oldum. Ard\u0131ndan Marmara \u00dcniversitesi Eczac\u0131l\u0131k Fak\u00fcltesi\u2019nde farmakoloji ve sonras\u0131nda da Hacettepe \u00dcniversitesi\u2019nde sa\u011fl\u0131k ekonomisi ve farmakoekonomi programlar\u0131nda \u00e7ift y\u00fcksek lisans yapt\u0131m. \u0130la\u00e7 sekt\u00f6r\u00fcnde 16 y\u0131ll\u0131k tecr\u00fcbeye sahibim ve bu s\u00fcre boyunca yerli ve global ila\u00e7 \u015firketlerinde ruhsatland\u0131rma, farmakovijilans, fiyatland\u0131rma ve geri \u00f6deme alanlar\u0131nda farkl\u0131 rollerde \u00e7al\u0131\u015ft\u0131m. 2021 y\u0131l\u0131 itibar\u0131yla GSK T\u00fcrkiye\u2019ye kat\u0131ld\u0131m. Ruhsatland\u0131rma direkt\u00f6r\u00fc olarak hem \u015firketimizin T\u00fcrkiye organizasyonunda liderlik ekibinin hem de geli\u015fen pazarlar b\u00f6lgesi ruhsatland\u0131rma liderlik ekibinin \u00fcyesi olarak g\u00f6rev al\u0131yorum.<\/p>\n\n\n\n

GSK T\u00fcrkiye Ruhsatland\u0131rma Ekibi\u2019ni tan\u0131yabilir miyiz? \u00d6nceliklerinizi ve sorumluluk alanlar\u0131n\u0131z\u0131 payla\u015fabilir misiniz?<\/strong><\/p>\n\n\n

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GSK T\u00fcrkiye Ruhsatland\u0131rma Departman\u0131, 11 ki\u015filik bir ekipten olu\u015fuyor. \u00d6nceli\u011fimiz ve odak noktam\u0131z; \u00f6nlenebilir hastal\u0131klar\u0131n tedavisinde kullan\u0131lan a\u015f\u0131lar\u0131m\u0131z\u0131 ve yenilik\u00e7i ila\u00e7lar\u0131m\u0131z\u0131 en k\u0131sa s\u00fcrede T\u00fcrkiye\u2019de ruhsatlayarak kullan\u0131ma sunmak. Sa\u011fl\u0131k Bakanl\u0131\u011f\u0131 T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (T\u0130TCK) nezdinde firmay\u0131 temsil ederek di\u011fer bir deyi\u015fle firma ile Kurum aras\u0131nda k\u00f6pr\u00fc olan birimiz.<\/p>\n\n\n\n

Firma i\u00e7erisinde de hem yerel hem de k\u00fcresel d\u00fczeyde yeni bir \u00fcr\u00fcn\u00fcn, ilk ke\u015ffinden itibaren portf\u00f6y\u00fcm\u00fczde yer alan \u00fcr\u00fcnlerin t\u00fcm ruhsatla ilgili s\u00fcre\u00e7lerini y\u00f6netiyoruz. Yeni \u00fcr\u00fcn ba\u015fvurusu, \u00f6nceliklendirme, endikasyon ve GMP s\u00fcre\u00e7leri gibi t\u00fcm stratejik planlamalar\u0131 yaparak hastalar\u0131n \u00fcr\u00fcnlerimize en k\u0131sa s\u00fcrede eri\u015fimi i\u00e7in firmam\u0131z i\u00e7erisinde ve d\u0131\u015f\u0131ndaki pek \u00e7ok payda\u015f ile i\u015f birli\u011fi halinde reg\u00fclasyonlarla uyumlu olarak s\u00fcre\u00e7lere liderlik ediyoruz. Ayn\u0131 zamanda mevcut ruhsatl\u0131 \u00fcr\u00fcnlerimizin ya\u015fam d\u00f6ng\u00fclerinin ve tedariklerinin devaml\u0131l\u0131\u011f\u0131 i\u00e7in de t\u00fcm s\u00fcre\u00e7lerini y\u00fcr\u00fct\u00fcyoruz.   <\/p>\n\n\n\n

GSK\u2019n\u0131n T\u00fcrkiye\u2019de hangi tedavi alanlar\u0131nda, ka\u00e7 ruhsatl\u0131 \u00fcr\u00fcn\u00fc mevcut? Ruhsat almay\u0131 bekledi\u011finiz yeni tedavi alanlar\u0131nda \u00fcr\u00fcnlerinin var m\u0131d\u0131r?<\/strong> <\/strong><\/strong><\/p>\n\n\n\n

GSK, 1959 y\u0131l\u0131ndan beri T\u00fcrkiye\u2019de a\u015f\u0131, enfeksiyon hastal\u0131klar\u0131, HIV, onkoloji, solunum ve imm\u00fcnoloji ba\u015fta olmak \u00fczere pek \u00e7ok tedavi alan\u0131nda a\u015f\u0131 ve ila\u00e7 stat\u00fcs\u00fcnde toplam 120\u2019nin \u00fczerinde ruhsatl\u0131 \u00fcr\u00fcnle faaliyet g\u00f6steriyor. Yenilik\u00e7i tedavi alanlar\u0131nda da hastalar\u0131m\u0131z\u0131n ihtiya\u00e7lar\u0131n\u0131 kar\u015f\u0131lamak amac\u0131yla t\u00fcm h\u0131z\u0131m\u0131zla \u00e7al\u0131\u015fmalar\u0131m\u0131z\u0131 s\u00fcrd\u00fcr\u00fcyoruz. Bahsi ge\u00e7en tedavi gruplar\u0131na ilave olarak firmam\u0131z\u0131n stratejik yakla\u015f\u0131m\u0131yla uyumlu olacak \u015fekilde, \u00fcr\u00fcnlerimizin hastalar\u0131m\u0131z\u0131n tedavisinde en k\u0131sa s\u00fcrede yer almas\u0131 i\u00e7in \u00e7al\u0131\u015fmalar\u0131m\u0131z devam ediyor.<\/p>\n\n\n\n

GSK olarak T\u00fcrkiye\u2019deki yat\u0131r\u0131mlar\u0131n\u0131zdan bahsedebilir misiniz? <\/strong> <\/p>\n\n\n\n

\u00dcr\u00fcnlerimizin ihtiyac\u0131 olan hastalara tedari\u011fini kesintisiz bir \u015fekilde s\u00fcrd\u00fcr\u00fcyor ve devletimizin sa\u011fl\u0131k politika hedeflerini desteklemek amac\u0131yla Sa\u011fl\u0131k Bakanl\u0131\u011f\u0131m\u0131z ile uzun y\u0131llard\u0131r yak\u0131n i\u015f birli\u011fi i\u00e7inde \u00e7al\u0131\u015f\u0131yoruz. Bu minvalde; bug\u00fcne kadar 4 stratejik yerel orta\u011f\u0131m\u0131zla ger\u00e7ekle\u015ftirdi\u011fimiz \u00fcretim yat\u0131r\u0131mlar\u0131m\u0131z neticesinde, 2024 y\u0131l\u0131 i\u00e7erisinde yerel \u00fcretim oran\u0131m\u0131z\u0131n kutu baz\u0131nda %75\u2019e ula\u015fmas\u0131 bekleniyor.<\/p>\n\n\n\n

Son olarak, stratejik orta\u011f\u0131m\u0131zla neb\u00fcllerin teknoloji transferini T\u00fcrkiye\u2019ye getirerek y\u00fcksek teknoloji gerektiren neb\u00fcl \u00fcretim tesisini hayata ge\u00e7irdik. Bahsi ge\u00e7en yat\u0131r\u0131mlar\u0131m\u0131za ilave olarak farkl\u0131 tedavi alanlar\u0131ndaki pek \u00e7ok klinik \u00e7al\u0131\u015fmay\u0131 \u00fclkemize getirerek \u00e7al\u0131\u015fmalar\u0131m\u0131z\u0131 s\u00fcrd\u00fcr\u00fcyoruz.  <\/p>\n\n\n\n

Ruhsatland\u0131rma alan\u0131nda \u00e7al\u0131\u015fmak i\u00e7in ne gibi yetkinlikler gerekiyor, ekibinize dahil olacak \u00e7al\u0131\u015fma arkada\u015flar\u0131n\u0131z \u00f6ncelikle hangi \u00f6zelliklere sahip olmal\u0131lar?<\/strong><\/p>\n\n\n\n

\u00d6ncelikle reg\u00fclasyonlara h\u00e2kim olmak ve g\u00fcncel trendleri takip etmek gerekiyor. GSK olarak farkl\u0131 tedavi ve \u00fcr\u00fcn gruplar\u0131nda geni\u015f ve h\u0131zla b\u00fcy\u00fcmeye devam eden bir portf\u00f6ye sahibimiz. Portf\u00f6y\u00fcm\u00fcz ve \u015firket k\u00fclt\u00fcr\u00fcm\u00fczle uyumlu olarak hastalar i\u00e7in tutkulu, i\u015finde etki yaratmak i\u00e7in \u00f6z sorumlu ve her ko\u015fulda do\u011fru olan\u0131 yapan \u00e7al\u0131\u015fanlar\u0131m\u0131z\u0131 ekibimize dahil ediyoruz. Bunun yan\u0131 s\u0131ra, \u015firket i\u00e7erisinde ve d\u0131\u015far\u0131s\u0131nda \u00e7ok farkl\u0131 payda\u015f ile \u00e7al\u0131\u015ft\u0131\u011f\u0131m\u0131zdan ileti\u015fimi kuvvetli, farkl\u0131 g\u00f6r\u00fc\u015flere a\u00e7\u0131k, tak\u0131m \u00e7al\u0131\u015fmas\u0131na yatk\u0131n, f\u0131rsatlar\u0131 ve riskleri de\u011ferlendirebilen ve yeni fikirler ve \u00e7\u00f6z\u00fcmler \u00fcreten, \u00e7evik ve esnekli\u011fi y\u00fcksek olmak da maj\u00f6r yetkinlikler aras\u0131nda yer al\u0131yor. T\u00fcm bunlar\u0131 yapmak i\u00e7in de merakl\u0131, ara\u015ft\u0131ran, her zaman geli\u015fmeye a\u00e7\u0131k ve istekli olmak en ba\u015fta geliyor. <\/p>\n\n\n\n

Ruhsatland\u0131rma s\u00fcrecinde \u00fclkemizde ya\u015fanan en \u00f6nemli sorunlar sizce neler? S\u00fcreci iyile\u015ftirebilme ad\u0131na ilgili kurumlardan ne gibi beklentileriniz var?<\/strong><\/p>\n\n\n\n

Ana payda\u015f\u0131m\u0131z olan T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu\u2019nun (T\u0130TCK) ICH, PIC\/S \u00fcyeli\u011fini ve 2023 y\u0131l\u0131ndaki DS\u00d6 taraf\u0131ndan belirlenen Ulusal D\u00fczenleyici Otorite olarak kabul edilmesini referans bir otorite olma hedefiyle uyumlu olarak \u00e7ok k\u0131ymetli buluyorum. Bununla birlikte kar\u015f\u0131lanmam\u0131\u015f ihtiyaca y\u00f6nelik yenilik\u00e7i stat\u00fcdeki \u00fcr\u00fcnlerin d\u00fcnya ile e\u015f zamanl\u0131 olarak ve\/veya k\u0131sa s\u00fcre sonra \u00fclkemizde ruhsatlanmas\u0131 ve hastalar\u0131n eri\u015fimine sunulmas\u0131 kritik \u00f6neme sahip. Denetim s\u00fcre\u00e7lerindeki \u00f6nceliklendirme uygulamalar\u0131na ilave olarak ruhsatland\u0131rma prosed\u00fcrlerinde de \u00f6nceliklendirilmenin mevzuatlara eklenerek hayata ge\u00e7irilmesi eri\u015fimin h\u0131zlanmas\u0131 a\u00e7\u0131s\u0131ndan \u00f6nemli. Bununla birlikte DS\u00d6 g\u00fcven uygulamas\u0131 kapsam\u0131n\u0131n geni\u015fletilerek tam bir g\u00fcven uygulamas\u0131n\u0131n hayata ge\u00e7irilmesi kurumumuzun globalle\u015fme ve referans otorite olma hedefleriyle de uyumlu olarak farkl\u0131 otoritelerle i\u015f birliklerini geli\u015ftirmek ve ayn\u0131 zamanda s\u00fcre\u00e7leri h\u0131zland\u0131rmak ad\u0131na \u00f6nem te\u015fkil ediyor.<\/p>\n","protected":false},"excerpt":{"rendered":"

1959 y\u0131l\u0131ndan beri T\u00fcrkiye\u2019de a\u015f\u0131, enfeksiyon hastal\u0131klar\u0131, HIV, onkoloji, solunum ve imm\u00fcnoloji ba\u015fta olmak \u00fczere pek \u00e7ok tedavi alan\u0131nda 120\u2019nin \u00fczerinde ruhsatl\u0131 \u00fcr\u00fcnle faaliyet g\u00f6steren GSK\u2019n\u0131n T\u00fcrkiye Ruhsatland\u0131rma Direkt\u00f6r\u00fc Elif Teoman \u00d6zg\u00fcr ile GSK T\u00fcrkiye Ruhsatland\u0131rma Birimi\u2019nin \u00e7al\u0131\u015fmalar\u0131n\u0131 konu\u015ftuk.<\/p>\n","protected":false},"author":1,"featured_media":3786,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[48,2],"tags":[],"_links":{"self":[{"href":"https:\/\/pharmaworlddergi.com\/index.php?rest_route=\/wp\/v2\/posts\/3783"}],"collection":[{"href":"https:\/\/pharmaworlddergi.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/pharmaworlddergi.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/pharmaworlddergi.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/pharmaworlddergi.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=3783"}],"version-history":[{"count":2,"href":"https:\/\/pharmaworlddergi.com\/index.php?rest_route=\/wp\/v2\/posts\/3783\/revisions"}],"predecessor-version":[{"id":3788,"href":"https:\/\/pharmaworlddergi.com\/index.php?rest_route=\/wp\/v2\/posts\/3783\/revisions\/3788"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pharmaworlddergi.com\/index.php?rest_route=\/wp\/v2\/media\/3786"}],"wp:attachment":[{"href":"https:\/\/pharmaworlddergi.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=3783"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmaworlddergi.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=3783"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmaworlddergi.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=3783"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}