{"id":3808,"date":"2024-11-19T10:37:18","date_gmt":"2024-11-19T07:37:18","guid":{"rendered":"https:\/\/pharmaworlddergi.com\/?p=3808"},"modified":"2024-11-19T10:38:35","modified_gmt":"2024-11-19T07:38:35","slug":"departmanimiz-hastalara-en-iyi-tedavi-seceneklerini-sunabilmek-amaciyla-bir-kopru-gorevini-ustleniyor","status":"publish","type":"post","link":"https:\/\/pharmaworlddergi.com\/?p=3808","title":{"rendered":"Departman\u0131m\u0131z, Hastalara En \u0130yi Tedavi Se\u00e7eneklerini Sunabilmek Amac\u0131yla Bir K\u00f6pr\u00fc G\u00f6revini \u00dcstleniyor"},"content":{"rendered":"\n

Takeda T\u00fcrkiye Ruhsatland\u0131rma Direkt\u00f6r\u00fc Deniz Acar, T\u00fcrkiye\u2019de ila\u00e7 ruhsatland\u0131rma s\u00fcreci ve Takeda T\u00fcrkiye Ruhsatland\u0131rma Departman\u0131\u2019n\u0131n \u00e7al\u0131\u015fmalar\u0131 hakk\u0131nda bilgi verdi.<\/strong><\/p>\n\n\n\n

\u015eirketinizi ve ruhsatland\u0131rma faaliyetlerinizi anlat\u0131r m\u0131s\u0131n\u0131z?<\/strong><\/p>\n\n\n

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243 y\u0131ld\u0131r faaliyette olan Takeda, 80 \u00fclkede 50.000 \u00e7al\u0131\u015fan\u0131 ile hastalar\u0131n hayatlar\u0131nda anlaml\u0131 farklar yaratmak i\u00e7in \u00e7al\u0131\u015fan, yenilik\u00e7i bir biyofarma \u015firketidir. T\u00fcrkiye’de, Takeda’n\u0131n k\u00fcresel misyonu do\u011frultusunda, yerel d\u00fczenlemelere tam uyum sa\u011flayarak hastalar\u0131n ihtiya\u00e7 duydu\u011fu yenilik\u00e7i tedavilerin etkin bir \u015fekilde sunulmas\u0131 i\u00e7in \u00e7al\u0131\u015fmalar\u0131m\u0131z\u0131 s\u00fcrd\u00fcr\u00fcyoruz.<\/p>\n\n\n\n

Takeda T\u00fcrkiye Ruhsatland\u0131rma Departman\u0131 olarak, ila\u00e7lar\u0131n g\u00fcvenli\u011fi, etkilili\u011fi ve kalitesinin belirlenmesi amac\u0131yla resmi otoritelerle ileti\u015fim halinde \u00e7al\u0131\u015f\u0131yoruz. Alan\u0131nda uzman dokuz ki\u015fiden olu\u015fan ekibimiz yeni ila\u00e7lar\u0131n ruhsatland\u0131rmas\u0131 ve ruhsatl\u0131 ila\u00e7lar\u0131m\u0131z\u0131n hastalar\u0131m\u0131za kesintisiz bir \u015fekilde ula\u015ft\u0131r\u0131lmas\u0131 i\u00e7in verilerin incelenmesi, gereken belgelerin haz\u0131rlanmas\u0131 ve ba\u015fvurular\u0131n takibi gibi s\u00fcre\u00e7leri titizlikle y\u00fcr\u00fct\u00fcyor. Departman\u0131m\u0131z, hastalara en iyi tedavi se\u00e7eneklerini sunabilmek amac\u0131yla bir k\u00f6pr\u00fc g\u00f6revini \u00fcstleniyor.  <\/p>\n\n\n\n

T\u00fcrkiye\u2019de bir ilac\u0131n ruhsatland\u0131rma s\u00fcreci nas\u0131l ilerliyor? \u0130lac\u0131n ruhsat ba\u015fvurusundan itibaren ruhsat s\u00fcreci tamamlanana kadar s\u00fcre\u00e7 nas\u0131l i\u015fliyor?<\/strong><\/p>\n\n\n\n

Ruhsatland\u0131rma s\u00fcrecinde ilk a\u015famada; T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu’na (T\u0130TCK) ilac\u0131n ruhsatland\u0131r\u0131lmas\u0131 i\u00e7in ba\u015fvuruda bulunuluyor ve ilac\u0131n g\u00fcvenli\u011fi, etkilili\u011fi ve kalitesini kan\u0131tlayan kapsaml\u0131 bilimsel veriler sunuluyor. T\u0130TCK, ba\u015fvurulardaki t\u00fcm verileri detayl\u0131 bir \u015fekilde inceliyor, de\u011ferlendiriyor ve gerekirse ek bilgi veya d\u00fczeltmeler talep edilebiliyor. De\u011ferlendirme s\u00fcrecinde; etkililik ve g\u00fcvenlik parametrelerine ek olarak hastalar\u0131n ilaca olan gereksinimini de (kar\u015f\u0131lanmam\u0131\u015f ihtiya\u00e7) dikkate al\u0131yor. T\u0130TCK, de\u011ferlendirme sonras\u0131nda, uygun buldu\u011fu taktirde ilac\u0131n ruhsat\u0131n\u0131 veriyor ve ruhsatland\u0131rma s\u00fcreci tamamland\u0131ktan sonra ila\u00e7 T\u00fcrkiye pazar\u0131nda ula\u015f\u0131labilir hale geliyor.<\/p>\n\n\n\n

Takeda\u2019n\u0131n odakland\u0131\u011f\u0131 tedavi alanlar\u0131 nelerdir? Bu alanlarda yeni \u00fcr\u00fcnleriniz olacak m\u0131?<\/strong><\/p>\n\n\n\n

Takeda, 2009 y\u0131l\u0131ndan bu yana T\u00fcrkiye\u2019de hematoloji, onkoloji, nadir genetik hastal\u0131klar, gastroenteroloji ve imm\u00fcnoloji alanlar\u0131nda \u00e7al\u0131\u015fmalar\u0131n\u0131 y\u00fcr\u00fct\u00fcyor. Ar-Ge odakl\u0131 bir kurum olarak her y\u0131l yakla\u015f\u0131k 4,8 milyar dolar b\u00fct\u00e7eyi Ar-Ge projelerine ay\u0131r\u0131yor. K\u00fcresel d\u00fczeyde 55 farkl\u0131 molek\u00fcl\u00fcn klinik \u00e7al\u0131\u015fma a\u015famas\u0131 devam eden g\u00fc\u00e7l\u00fc bir \u00fcr\u00fcn portf\u00f6y\u00fcne sahibiz. Son 10 y\u0131lda tedavi alanlar\u0131m\u0131z kapsam\u0131nda 13 \u00fcr\u00fcn\u00fc T\u00fcrk t\u0131bb\u0131n\u0131n hizmetine sunduk. Ayr\u0131ca, 34 merkezde bilim odakl\u0131l\u0131k ve inovasyon prensipleriyle y\u00fcr\u00fct\u00fclen 11 aktif klinik \u00e7al\u0131\u015fmam\u0131z devam ediyor. <\/p>\n\n\n\n

Takeda\u2019n\u0131n T\u00fcrkiye\u2019de ruhsatl\u0131 ka\u00e7 \u00fcr\u00fcn\u00fc mevcut, ruhsat ba\u015fvurusunda bulundu\u011funuz ve ruhsat almay\u0131 bekledi\u011finiz ka\u00e7 \u00fcr\u00fcn\u00fcn\u00fcz var ve hangi tedavi alanlar\u0131nda?<\/strong><\/strong><\/p>\n\n\n\n

Takeda T\u00fcrkiye olarak ruhsatl\u0131 29 adet \u00fcr\u00fcn\u00fcm\u00fcz hastalar\u0131n tedaviye eri\u015fimi i\u00e7in ula\u015f\u0131labilir durumda. hematoloji, onkoloji, imm\u00fcnoloji, genetik hastal\u0131klar, gastroenteroloji tedavi alanlar\u0131nda ruhsat ba\u015fvuru s\u00fcreci devam eden 5 adet \u00fcr\u00fcn\u00fcm\u00fcz bulunuyor. 6 \u00fcr\u00fcn\u00fcm\u00fcz i\u00e7in ise \u00f6n\u00fcm\u00fczdeki d\u00f6nemde ruhsat ba\u015fvurusunda bulunmay\u0131 planl\u0131yoruz.<\/p>\n\n\n\n

C-ANPROM\/TR\/CORP\/0226<\/kbd><\/em><\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"

Takeda T\u00fcrkiye Ruhsatland\u0131rma Direkt\u00f6r\u00fc Deniz Acar, T\u00fcrkiye\u2019de ila\u00e7 ruhsatland\u0131rma s\u00fcreci ve Takeda T\u00fcrkiye Ruhsatland\u0131rma Departman\u0131\u2019n\u0131n \u00e7al\u0131\u015fmalar\u0131 hakk\u0131nda bilgi verdi.<\/p>\n","protected":false},"author":1,"featured_media":3809,"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\/3808"}],"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=3808"}],"version-history":[{"count":2,"href":"https:\/\/pharmaworlddergi.com\/index.php?rest_route=\/wp\/v2\/posts\/3808\/revisions"}],"predecessor-version":[{"id":3812,"href":"https:\/\/pharmaworlddergi.com\/index.php?rest_route=\/wp\/v2\/posts\/3808\/revisions\/3812"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pharmaworlddergi.com\/index.php?rest_route=\/wp\/v2\/media\/3809"}],"wp:attachment":[{"href":"https:\/\/pharmaworlddergi.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=3808"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmaworlddergi.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=3808"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmaworlddergi.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=3808"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}