{"id":3775,"date":"2024-11-14T08:35:04","date_gmt":"2024-11-14T05:35:04","guid":{"rendered":"https:\/\/pharmaworlddergi.com\/?p=3775"},"modified":"2024-11-14T08:37:52","modified_gmt":"2024-11-14T05:37:52","slug":"onceligimiz-yeni-tedavilerimizi-turk-tibbinin-hizmetine-en-hizli-ve-guvenli-sekilde-sunmak","status":"publish","type":"post","link":"https:\/\/pharmaworlddergi.com\/?p=3775","title":{"rendered":"\u00d6nceli\u011fimiz, Yeni Tedavilerimizi T\u00fcrk T\u0131bb\u0131n\u0131n Hizmetine En H\u0131zl\u0131 ve G\u00fcvenli \u015eekilde Sunmak"},"content":{"rendered":"\n<p><strong>Novartis T\u00fcrkiye Ruhsatland\u0131rma Direkt\u00f6r\u00fc Ecz. Reyhan Ta\u015f\u00e7\u0131o\u011flu ile T\u00fcrkiye\u2019de ila\u00e7 ruhsatland\u0131rma s\u00fcreci, bu s\u00fcre\u00e7le ilgili iyile\u015ftirilmesi gereken alanlar ve Novartis T\u00fcrkiye Ruhsatland\u0131rma Departman\u0131\u2019n\u0131n \u00e7al\u0131\u015fmalar\u0131 \u00fczerine bir sohbet ger\u00e7ekle\u015ftirdik.<\/strong><\/p>\n\n\n\n<p><strong>Sizi ve Novartis T\u00fcrkiye Ruhsatland\u0131rma Ekibi\u2019ni tan\u0131yabilir miyiz?<\/strong><\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"alignleft size-large is-resized\"><img loading=\"lazy\" decoding=\"async\" width=\"681\" height=\"1024\" src=\"https:\/\/pharmaworlddergi.com\/wp-content\/uploads\/2024\/11\/Ecz_Reyhan_Tascioglu_Ruhsatlandirma_Direktoru_Novartis_Turkiye-681x1024.jpg\" alt=\"\" class=\"wp-image-3776\" style=\"width:165px;height:auto\" srcset=\"https:\/\/pharmaworlddergi.com\/wp-content\/uploads\/2024\/11\/Ecz_Reyhan_Tascioglu_Ruhsatlandirma_Direktoru_Novartis_Turkiye-681x1024.jpg 681w, https:\/\/pharmaworlddergi.com\/wp-content\/uploads\/2024\/11\/Ecz_Reyhan_Tascioglu_Ruhsatlandirma_Direktoru_Novartis_Turkiye-200x300.jpg 200w, https:\/\/pharmaworlddergi.com\/wp-content\/uploads\/2024\/11\/Ecz_Reyhan_Tascioglu_Ruhsatlandirma_Direktoru_Novartis_Turkiye-768x1154.jpg 768w, https:\/\/pharmaworlddergi.com\/wp-content\/uploads\/2024\/11\/Ecz_Reyhan_Tascioglu_Ruhsatlandirma_Direktoru_Novartis_Turkiye-1022x1536.jpg 1022w, https:\/\/pharmaworlddergi.com\/wp-content\/uploads\/2024\/11\/Ecz_Reyhan_Tascioglu_Ruhsatlandirma_Direktoru_Novartis_Turkiye-1363x2048.jpg 1363w, https:\/\/pharmaworlddergi.com\/wp-content\/uploads\/2024\/11\/Ecz_Reyhan_Tascioglu_Ruhsatlandirma_Direktoru_Novartis_Turkiye-scaled.jpg 1703w\" sizes=\"(max-width: 681px) 100vw, 681px\" \/><\/figure><\/div>\n\n\n<p>\u0130stanbul \u00dcniversitesi Eczac\u0131l\u0131k Fak\u00fcltesi ve Marmara \u00dcniversitesi \u00c7a\u011fda\u015f Y\u00f6netim Teknikleri ihtisas program\u0131 mezunuyum. Yakla\u015f\u0131k 30 y\u0131la yak\u0131n bir s\u00fcredir ila\u00e7 sekt\u00f6r\u00fcnde \u00e7al\u0131\u015f\u0131yorum. Sat\u0131\u015f m\u00fcmessili olarak ba\u015flad\u0131\u011f\u0131m profesyonel i\u015f hayat\u0131m boyunca farkl\u0131 firmalarda sat\u0131\u015f, pazarlama, sa\u011fl\u0131k ekonomisi, pazara eri\u015fim gibi alanlarda y\u00f6netici olarak g\u00f6rev yapt\u0131m. Novartis\u2019in onkoloji biriminde sa\u011fl\u0131k politikalar\u0131 ve pazar eri\u015fim b\u00f6l\u00fcm m\u00fcd\u00fcr\u00fc olarak 2009 y\u0131l\u0131nda ba\u015flayan yolculu\u011fuma 2015 y\u0131l\u0131ndan bu yana global ila\u00e7 geli\u015ftirme yap\u0131s\u0131 i\u00e7erisinde \u00fclke ruhsatland\u0131rma direkt\u00f6r\u00fc olarak devam ediyorum.<\/p>\n\n\n\n<p>Novartis T\u00fcrkiye Ruhsatland\u0131rma Departman\u0131\u2019m\u0131z; m\u00fcd\u00fcr, uzman ve k\u0131demli uzmanlardan olu\u015fuyor. S\u00fcre\u00e7 geli\u015ftirme ve m\u00fckemmeliyet m\u00fcd\u00fcr\u00fc, ruhsatland\u0131rma kamu ili\u015fkileri m\u00fcd\u00fcr\u00fc, klinik ara\u015ft\u0131rmalar ba\u015fvuru sorumlusu ve departman koordinat\u00f6r\u00fc olarak g\u00f6rev yapmakta olan arkada\u015flar\u0131mla 17 ki\u015filik bir ekip olarak \u00e7al\u0131\u015f\u0131yoruz.<\/p>\n\n\n\n<p><strong>Ruhsatland\u0131rma biriminin \u015firket i\u00e7indeki ve d\u0131\u015f\u0131ndaki payda\u015flar\u0131 kimler, payda\u015flar\u0131n\u0131zla nas\u0131l i\u015f birlikleri y\u00fcr\u00fct\u00fcyorsunuz?<\/strong><\/p>\n\n\n\n<p>Ruhsatland\u0131rma departmanlar\u0131n\u0131n ana amac\u0131; t\u0131bbi cihaz ve ila\u00e7 gibi \u00fcr\u00fcnlerin \u00fclkemizde ruhsat\u0131n\u0131n al\u0131narak t\u0131bb\u0131n hizmetine sunulmas\u0131n\u0131 sa\u011flamakt\u0131r. Bir\u00e7ok i\u00e7 payda\u015f\u0131m\u0131zla i\u015f birli\u011fi yaparak ila\u00e7lar\u0131m\u0131z\u0131n klinik ara\u015ft\u0131rma a\u015famas\u0131ndan ba\u015flayarak piyasaya sunulma s\u00fcrecini y\u00f6netiyoruz.<\/p>\n\n\n\n<p>Ruhsatland\u0131rma departman\u0131 olarak sorumluluklar\u0131m\u0131z dahilinde olan rutin i\u015flerimiz do\u011frultusunda global ve lokal bir\u00e7ok b\u00f6l\u00fcm ile i\u015f birli\u011fi i\u00e7erisinde \u00e7al\u0131\u015f\u0131yoruz. Novartis T\u00fcrkiye organizasyonu i\u00e7erisinde en \u00e7ok medikal, pazara eri\u015fim, kanal y\u00f6netimi, tedarik zinciri, pazarlama, hasta g\u00fcvenli\u011fi, kalite ve \u00f6zellikle portf\u00f6y\u00fcm\u00fczdeki yerel \u00fcretilen \u00fcr\u00fcnlerin say\u0131s\u0131n\u0131n da olduk\u00e7a y\u00fcksek olmas\u0131 nedeniyle, d\u00fcnyadaki stratejik \u00fcretim tesislerimizden biri olan Kurtk\u00f6y fabrikam\u0131z\u0131n ilgili birimleriyle \u00e7al\u0131\u015f\u0131yoruz. Departman olarak, \u015firketin hemen hemen her s\u00fcrecinin i\u00e7erisinde bulundu\u011fumuzdan t\u00fcm departmanlar ile i\u015f birli\u011fi i\u00e7erisindeyiz.<\/p>\n\n\n\n<p>Global ila\u00e7 geli\u015ftirme yap\u0131s\u0131 i\u00e7erisinde klinik ara\u015ft\u0131rmalar ve hasta g\u00fcvenli\u011fi departmanlar\u0131 ile birlikte yer alan T\u00fcrkiye ruhsatland\u0131rma b\u00f6l\u00fcm\u00fcm\u00fcz, Avrupa, Amerika, \u00c7in ve Japonya d\u0131\u015f\u0131nda kalan \u00fclkeleri kapsayan b\u00f6lgeye (Most of the World) do\u011frudan ba\u011fl\u0131 olan 2 \u00fclkeden biridir. Tedavi alanlar\u0131 ve \u00fcr\u00fcnler baz\u0131nda, globalde \u00e7al\u0131\u015fan t\u00fcm ruhsatland\u0131rma birimleri ile yak\u0131n ileti\u015fimde olarak T.C. Sa\u011fl\u0131k Bakanl\u0131\u011f\u0131 taraf\u0131ndan belirlenmi\u015f olan kurallar \u00e7er\u00e7evesinde d\u00fcnyada ruhsatland\u0131r\u0131lm\u0131\u015f olan yenilik\u00e7i ila\u00e7lar\u0131m\u0131z\u0131n T\u00fcrk t\u0131bb\u0131n\u0131n kullan\u0131m\u0131na ula\u015fabilmesi i\u00e7in uyum ve m\u00fckemmeliyet i\u00e7erisinde \u00e7al\u0131\u015f\u0131yoruz.<\/p>\n\n\n\n<p>\u015eirket harici ba\u015fl\u0131ca payda\u015f\u0131m\u0131z olan ve \u00fclkemizin onaylay\u0131c\u0131 otoritesi T.C. Sa\u011fl\u0131k Bakanl\u0131\u011f\u0131 i\u00e7erisinde yer alan T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu ile \u00fcr\u00fcnlerimizin ruhsatland\u0131rma ve ya\u015fam d\u00f6ng\u00fcs\u00fc y\u00f6netimi, s\u00fcre\u00e7lerin takibi, kanun, y\u00f6netmelik ve k\u0131lavuzlara tam uyumun sa\u011flanmas\u0131 konusunda yak\u0131nen \u00e7al\u0131\u015f\u0131yoruz.<\/p>\n\n\n\n<p>Di\u011fer harici payda\u015f\u0131m\u0131z olan A\u0130FD\u2019nin ruhsatland\u0131rma \u00f6zelindeki \u00e7al\u0131\u015fmalar\u0131na dahil oluyoruz ve T\u00fcrkiye ruhsatland\u0131rma ortam\u0131n\u0131n ve sekt\u00f6r\u00fcn geli\u015fimine katk\u0131da bulunmak amac\u0131yla olu\u015fturulmu\u015f \u00e7al\u0131\u015fma gruplar\u0131na aktif bir \u015fekilde kat\u0131l\u0131yoruz. Bunun yan\u0131 s\u0131ra, sekt\u00f6rel geli\u015fmeleri de dernekteki meslekta\u015flar\u0131m ile takip ediyoruz.<\/p>\n\n\n\n<p><strong>Ruhsatland\u0131rma birimi olarak faaliyetlerinizi biraz anlat\u0131r m\u0131s\u0131n\u0131z, neler yap\u0131yorsunuz?<\/strong><\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"alignleft size-large is-resized\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"681\" src=\"https:\/\/pharmaworlddergi.com\/wp-content\/uploads\/2024\/11\/DSC_9350_pp-1024x681.jpg\" alt=\"\" class=\"wp-image-3777\" style=\"width:306px;height:auto\" srcset=\"https:\/\/pharmaworlddergi.com\/wp-content\/uploads\/2024\/11\/DSC_9350_pp-1024x681.jpg 1024w, https:\/\/pharmaworlddergi.com\/wp-content\/uploads\/2024\/11\/DSC_9350_pp-300x200.jpg 300w, https:\/\/pharmaworlddergi.com\/wp-content\/uploads\/2024\/11\/DSC_9350_pp-768x511.jpg 768w, https:\/\/pharmaworlddergi.com\/wp-content\/uploads\/2024\/11\/DSC_9350_pp-1536x1021.jpg 1536w, https:\/\/pharmaworlddergi.com\/wp-content\/uploads\/2024\/11\/DSC_9350_pp-2048x1362.jpg 2048w, https:\/\/pharmaworlddergi.com\/wp-content\/uploads\/2024\/11\/DSC_9350_pp-310x205.jpg 310w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure><\/div>\n\n\n<p>T\u00fcrkiye\u2019de faaliyet g\u00f6sterdi\u011fimiz tedavi alanlar\u0131m\u0131za uyumlu olarak, \u00fclkemizin sa\u011fl\u0131k sistemine katk\u0131 sa\u011flayacak ve hastalar\u0131n ihtiya\u00e7lar\u0131n\u0131 kar\u015f\u0131layacak yeni \u00fcr\u00fcnlerin T\u00fcrk t\u0131bb\u0131n\u0131n hizmetine sunulmas\u0131 amac\u0131m\u0131z do\u011frultusunda \u00e7al\u0131\u015f\u0131yoruz.<\/p>\n\n\n\n<p>Ekip olarak, tedavilerimizin \u00fclkemizde piyasaya sunulmas\u0131na y\u00f6nelik yasal onaylar\u0131n al\u0131nmas\u0131n\u0131 sa\u011flamak i\u00e7in \u00f6ncelikli olarak hem operasyonel hem de stratejik d\u00fczeyde planlamalara erken fazda ba\u015fl\u0131yoruz. Ruhsatland\u0131r\u0131lmas\u0131 planlanan \u00fcr\u00fcn\u00fcn \u00f6zelliklerini, klinik \u00e7al\u0131\u015fma sonu\u00e7lar\u0131na ba\u011fl\u0131 endikasyonlar\u0131n\u0131, g\u00fcvenlili\u011fini i\u00e7eren, \u00fclkemiz mevzuatlar\u0131na tam uyumlu ba\u015fvuru dosyas\u0131n\u0131n sunulmas\u0131n\u0131n yan\u0131 s\u0131ra, haz\u0131rlanmas\u0131ndan da sorumluyuz.<\/p>\n\n\n\n<p>Tedavilerimizin hekim ve hastalar\u0131n hizmetine en h\u0131zl\u0131 ve en g\u00fcvenli \u015fekilde sunulabilmesi her zaman \u00f6nceli\u011fimizdir. Bunun yan\u0131 s\u0131ra, gelecekteki potansiyel de\u011fi\u015fiklikleri ve d\u00fczenlemeleri de g\u00f6z \u00f6n\u00fcnde bulundurarak s\u00fcre\u00e7lerimizi proaktif bir \u015fekilde optimize etmeye \u00e7al\u0131\u015f\u0131yoruz. Bu dengeyi sa\u011flayabilmek, hastalar\u0131n hayatlar\u0131nda olumlu fark yaratma hedefimize ba\u011fl\u0131 kalabilmemiz i\u00e7in son derece \u00f6nemli.&nbsp;&nbsp;&nbsp;&nbsp;<\/p>\n\n\n\n<p><strong>T\u00fcrkiye\u2019de bir ilac\u0131n ruhsatland\u0131rma s\u00fcreci nas\u0131l ilerliyor? \u0130lac\u0131n ruhsat ba\u015fvurusundan itibaren ruhsat s\u00fcreci tamamlana kadar s\u00fcre\u00e7 nas\u0131l i\u015fliyor?<\/strong><\/p>\n\n\n\n<p>\u00dclkemizde ila\u00e7lar\u0131n ruhsatland\u0131rma s\u00fcre\u00e7leri T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (T\u0130TCK) taraf\u0131ndan kanun, y\u00f6netmelik ve mevzuatlara uygun olarak y\u00fcr\u00fct\u00fclmektedir. Bu s\u00fcre\u00e7, ilac\u0131n g\u00fcvenlili\u011fi, etkinli\u011fi, klinik ara\u015ft\u0131rma sonu\u00e7lar\u0131, \u00fcretim s\u00fcre\u00e7leri, form\u00fclasyonu ve kalitesi gibi daha \u00f6nce de k\u0131saca de\u011findi\u011fim b\u00f6l\u00fcmleri i\u00e7eren ruhsat ba\u015fvuru dosyas\u0131n\u0131n haz\u0131rlanmas\u0131 ve kuruma sunulmas\u0131 ile ba\u015flar. Sonras\u0131nda yetkili otorite taraf\u0131ndan detayl\u0131 bir bilimsel ve teknik inceleme s\u00fcreci ile devam eder. \u00dcretim s\u00fcrecinin iyi \u00fcretim uygulamalar\u0131 standartlar\u0131na g\u00f6re incelenmesi veya gerek duyulursa denetlenmesi de bu a\u015famada yap\u0131l\u0131r. T\u00fcm bu incelemeler sonucunda ilac\u0131n T\u00fcrkiye\u2019de t\u0131bb\u0131n hizmetine uygun olup olmad\u0131\u011f\u0131na karar verilir.<\/p>\n\n\n\n<p>T\u00fcm a\u015famalar olumlu sonu\u00e7lan\u0131rsa, T\u0130TCK ilaca ruhsat verilmesi y\u00f6n\u00fcnde karar\u0131n\u0131 bildirir fakat ruhsatland\u0131rma s\u00fcrekli devam eden bir s\u00fcre\u00e7tir. \u0130lac\u0131n hekim ve hastalar i\u00e7in t\u0131bb\u0131n hizmetine sunulmas\u0131ndan sonra da kalitesi, g\u00fcvenlili\u011fi, yan etkileri ve etkinli\u011fi d\u00fczenli olarak kontrole tabiidir.&nbsp;<\/p>\n\n\n\n<p><strong>\u00dclkemizde ruhsatland\u0131rma s\u00fcrecine y\u00f6nelik olarak neler iyile\u015ftirilebilir?<\/strong><\/p>\n\n\n\n<p>Ruhsatland\u0131rmaya y\u00f6nelik de\u011ferlendirme s\u00fcrelerinin uzunlu\u011fu her ne kadar titiz yakla\u015f\u0131mlar\u0131n do\u011fal bir sonucu olsa da ila\u00e7lar\u0131n piyasaya sunulmas\u0131n\u0131n yava\u015f ilerlemesine sebep olabiliyor. \u00d6zellikle tedavisi olmayan veya k\u0131s\u0131tl\u0131 tedavisi olan hastal\u0131klar i\u00e7in geli\u015ftirilen ila\u00e7lara hastalar\u0131n eri\u015fiminde gecikmelere yol a\u00e7abiliyor. Bu noktada, s\u00fcre\u00e7leri h\u0131zland\u0131rabilecek elektronik ba\u015fvurular\u0131n dijital altyap\u0131s\u0131n\u0131n g\u00fc\u00e7lendirilmesine y\u00f6nelik otomasyon yat\u0131r\u0131mlar\u0131n\u0131n b\u00fcy\u00fck bir \u00f6nem ta\u015f\u0131d\u0131\u011f\u0131na inan\u0131yoruz. Gelecekte bu s\u00fcre\u00e7lerin etkinli\u011fini art\u0131racak ad\u0131mlara uyumlanmak i\u00e7in \u00fczerimize d\u00fc\u015feni yapmak bizim de \u00f6nceliklerimiz aras\u0131nda.<\/p>\n\n\n\n<p><strong>T\u00fcrkiye\u2019deki ve uluslararas\u0131 d\u00fczenlemelerdeki geli\u015fmeleri ve de\u011fi\u015fiklikleri nas\u0131l takip ediyorsunuz ve firman\u0131z\u0131n bu d\u00fczenlemelere uyumunu sa\u011flamak \u00fczere neler yap\u0131yorsunuz?<\/strong><\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"alignleft size-large is-resized\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"681\" src=\"https:\/\/pharmaworlddergi.com\/wp-content\/uploads\/2024\/11\/Ecz_Reyhan_Tascioglu_Ruhsatlandirma_Direktoru_Novartis_Turkiye_1-1024x681.jpg\" alt=\"\" class=\"wp-image-3778\" style=\"width:319px;height:auto\" srcset=\"https:\/\/pharmaworlddergi.com\/wp-content\/uploads\/2024\/11\/Ecz_Reyhan_Tascioglu_Ruhsatlandirma_Direktoru_Novartis_Turkiye_1-1024x681.jpg 1024w, https:\/\/pharmaworlddergi.com\/wp-content\/uploads\/2024\/11\/Ecz_Reyhan_Tascioglu_Ruhsatlandirma_Direktoru_Novartis_Turkiye_1-300x200.jpg 300w, https:\/\/pharmaworlddergi.com\/wp-content\/uploads\/2024\/11\/Ecz_Reyhan_Tascioglu_Ruhsatlandirma_Direktoru_Novartis_Turkiye_1-768x511.jpg 768w, https:\/\/pharmaworlddergi.com\/wp-content\/uploads\/2024\/11\/Ecz_Reyhan_Tascioglu_Ruhsatlandirma_Direktoru_Novartis_Turkiye_1-1536x1021.jpg 1536w, https:\/\/pharmaworlddergi.com\/wp-content\/uploads\/2024\/11\/Ecz_Reyhan_Tascioglu_Ruhsatlandirma_Direktoru_Novartis_Turkiye_1-2048x1362.jpg 2048w, https:\/\/pharmaworlddergi.com\/wp-content\/uploads\/2024\/11\/Ecz_Reyhan_Tascioglu_Ruhsatlandirma_Direktoru_Novartis_Turkiye_1-310x205.jpg 310w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure><\/div>\n\n\n<p>Novartis T\u00fcrkiye Ruhsatland\u0131rma Departman\u0131 olarak \u00fclkemizdeki mevzuatlar\u0131, yenilikleri ve de\u011fi\u015fiklikleri yak\u0131ndan takip etmek \u00f6nceli\u011fimiz. Bunun yan\u0131 s\u0131ra global i\u015fleyi\u015fimizi de g\u00f6z \u00f6n\u00fcnde bulundurarak k\u00fcresel s\u00fcre\u00e7lere de uyumlanma konusunda son derece \u00e7evik bir ekip oldu\u011fumuzu belirtmek isterim.<\/p>\n\n\n\n<p>Globalde \u00f6nc\u00fc oldu\u011fumuz yenilik\u00e7i t\u0131bbi tedavi \u00fcr\u00fcnlerinin, \u00fcretim teknolojilerinin, veri \u00fcretiminde yapay zek\u00e2 uygulamalar\u0131n\u0131n T\u00fcrkiye\u2019deki yans\u0131malar\u0131n\u0131 da g\u00f6rmeyi istiyoruz. Novartis T\u00fcrkiye olarak d\u00fczenlemelere uyumu sa\u011flamak amac\u0131yla, i\u00e7 s\u00fcre\u00e7lerimizi ve politikalar\u0131m\u0131z\u0131 d\u00fczenli olarak g\u00f6zden ge\u00e7iriyoruz. T\u00fcm bu \u00e7al\u0131\u015fmalar, hem yerel hem de global d\u00fczeydeki d\u00fczenlemelere uyumumuzu art\u0131rmam\u0131za yard\u0131mc\u0131 oluyor.<\/p>\n\n\n\n<p><strong>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<p>\u0130la\u00e7 sekt\u00f6r\u00fcnde ruhsatland\u0131rma alan\u0131nda uzmanla\u015fmak i\u00e7in \u00f6ncelikle sa\u011fl\u0131k ve ila\u00e7 sekt\u00f6r\u00fcne y\u00f6nelik bir bilgi birikimine sahip olmak, i\u015fleyi\u015fi anlamak \u00f6nemlidir. Her alanda oldu\u011fu gibi, ruhsatland\u0131rma alan\u0131nda da deneyimler kazanarak bunu sa\u011flamak m\u00fcmk\u00fcn. Mevzuata hakimiyet ve d\u00fczenleyici gereklilikler konusunda bilgi sahibi olmak potansiyel zorluklara veya aksamalara h\u0131zla yan\u0131t vermek i\u00e7in son derece k\u0131ymetli. \u0130lgili d\u00fczenleyici otoritelerin, \u00fclkemiz \u00f6zelinde T\u0130TCK\u2019n\u0131n s\u00fcre\u00e7lerini ve standartlar\u0131n\u0131 takip etmek, g\u00fcncel kalmak a\u00e7\u0131s\u0131ndan kritik \u00f6neme sahip. Ek olarak belirtmeliyim ki analitik d\u00fc\u015f\u00fcnmek, karma\u015f\u0131k verileri anlamland\u0131rabilmek de \u00f6nemli.<\/p>\n\n\n\n<p>Bu alanda \u00e7al\u0131\u015fmak isteyen gen\u00e7 arkada\u015flar\u0131m\u0131n detayc\u0131 bak\u0131\u015f a\u00e7\u0131lar\u0131n\u0131 g\u00fc\u00e7lendirmelerini, hizmet verdikleri co\u011frafyan\u0131n yasal gerekliliklerini, sa\u011fl\u0131k sistemlerini anlamalar\u0131n\u0131 tavsiye edebilirim. S\u00fcre\u00e7lerin gelecekte ve zaman i\u00e7erisinde geli\u015fmesi ka\u00e7\u0131n\u0131lmaz, dolay\u0131s\u0131yla proaktif bir \u015fekilde bu geli\u015fimlerin \u015fekillenmesi \u00fczerine d\u00fc\u015f\u00fcnmek, bilim odakl\u0131 ve etkili politikalar\u0131 \u00f6nerebilecek donan\u0131ma sahip olabilmek de k\u0131ymetli bir \u00f6zellik.<\/p>\n\n\n\n<p>Ayr\u0131ca, uluslararas\u0131 farkl\u0131 sa\u011fl\u0131k otoritelerinin d\u00fczenlemelerini de takip ederek, lokalde veya di\u011fer \u00fclkelerde yap\u0131lan iyi uygulamalar\u0131n ve geli\u015fmeye a\u00e7\u0131k alanlar\u0131n tespit edilmesi, bu alanlardaki \u00f6rneklerin bilinmesi de her zaman i\u00e7in analitik ve stratejik bak\u0131\u015f a\u00e7\u0131s\u0131n\u0131n geli\u015ftirilmesinde faydal\u0131 olacakt\u0131r.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Novartis T\u00fcrkiye Ruhsatland\u0131rma Direkt\u00f6r\u00fc Ecz. Reyhan Ta\u015f\u00e7\u0131o\u011flu ile T\u00fcrkiye\u2019de ila\u00e7 ruhsatland\u0131rma s\u00fcreci, bu s\u00fcre\u00e7le ilgili iyile\u015ftirilmesi gereken alanlar ve Novartis T\u00fcrkiye Ruhsatland\u0131rma Departman\u0131\u2019n\u0131n \u00e7al\u0131\u015fmalar\u0131 \u00fczerine bir sohbet ger\u00e7ekle\u015ftirdik.<\/p>\n","protected":false},"author":1,"featured_media":3782,"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\/3775"}],"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=3775"}],"version-history":[{"count":2,"href":"https:\/\/pharmaworlddergi.com\/index.php?rest_route=\/wp\/v2\/posts\/3775\/revisions"}],"predecessor-version":[{"id":3781,"href":"https:\/\/pharmaworlddergi.com\/index.php?rest_route=\/wp\/v2\/posts\/3775\/revisions\/3781"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pharmaworlddergi.com\/index.php?rest_route=\/wp\/v2\/media\/3782"}],"wp:attachment":[{"href":"https:\/\/pharmaworlddergi.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=3775"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmaworlddergi.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=3775"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmaworlddergi.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=3775"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}