idare faaliyet raporu idare faaliyet raporu

  • View
    270

  • Download
    19

Embed Size (px)

Text of idare faaliyet raporu idare faaliyet raporu

  • 2015DARE FAALYET RAPORU

    2015DARE FAALYET RAPORU

  • DARE FAALYET RAPORU / 2015

    2015 YILI DARE FAALYET RAPORU

    UBAT-2016

  • DARE FAALYET RAPORU / 2015

    II

    Beni Trk Hekimlerine Emanet Ediniz

    Gazi Mustafa Kemal ATATRK

  • DARE FAALYET RAPORU / 2015

    III

    KISALTMALAR .............................................................................................................................................. X

    SUNU ........................................................................................................................................................... 3

    I GENEL BLGLER .................................................................................................................................... 5

    A VZYON, MSYON, TEMEL LKE VE DEERLER.............................................................................. 5

    Temel lke ve Deerler .........................................................................................................................................................7

    B YETK, GREV VE SORUMLULUKLAR ............................................................................................ 9

    Tarihi Geliim ...........................................................................................................................................................................9

    Kurumun Grev ve Sorumluluklar ...................................................................................................................................11

    C DAREYE LKN BLGLER ................................................................................................................ 15

    1 FZKSEL YAPI ..................................................................................................................................................................15

    2 TEKLAT YAPISI ............................................................................................................................................................15

    3 BLG VE TEKNOLOJK KAYNAKLAR .......................................................................................................................17

    3.1 Biliim Sistemleri .....................................................................................................................................................17

    3.2 Teknolojik Kaynaklar...............................................................................................................................................19

    3.2.1 Veri Toplama ve Veriyi Bilgiye Dntrme Sistemleri .......................................................................20

    3.2.1.1 la Takip Sistemi (TS) ...........................................................................................................................20

    3.2.1.2 rn Takip Sistemi (TS) .......................................................................................................................21

    3.2.1.3 Elektronik Bilgi Ynetim Sistemi (Yeni Nesil EBYS) .....................................................................23

    3.2.1.4 Ruhsatsz ve Endikasyon D la Ynetim Sistemi (REYS) ....................................................23

    3.2.1.5 Elektronik Renkli Reete Sistemi ........................................................................................................24

    3.2.1.6 Piyasa Gzetim ve Denetim Sistemi Yazlm .................................................................................24

    3.2.1.7 E-Uygulamalar ve Dokman Ynetim Sistemi Projesi (EUP) ...................................................24

    3.2.1.8 Paket Transfer Sistemi (PTS) ...............................................................................................................25

    3.2.1.9 Reete Bilgi Sistemi (RBS) ....................................................................................................................25

    3.2.1.10 Trkiye la ve Tbbi Cihaz Ulusal Bilgi Bankas Portal (TTUBB) ......................................26

    3.2.1.11 Klinik Aratrmalar Portal (KAP).......................................................................................................26

    3.2.1.12 Eczac Yerletirme Sistemi (EYS) .....................................................................................................27

    3.2.2 Veritaban, A ve Sunucu Sistemleri ............................................................................................................28

    3.2.2.1 Sistem ve Bilgi Gvenlii ..............................................................................................................................29

    3.2.3 Kullanc Destek Hizmetleri ..............................................................................................................................30

    3.2.3.1 Teknik Destek Yazlm (TDS) .......................................................................................................................30

    3.3 Teknolojik Aletler ve Donanmlar .............................................................................................................................31

    4- NSAN KAYNAKLARI ........................................................................................................................................................36

    5- KURUM TARAFINDAN SUNULAN HZMETLER .....................................................................................................40

    5.1 la ve Eczaclk Bakan Yardmcl................................................................................................................40

    5.1.1 la Ruhsatlandrma Dairesi Bakanl ...............................................................................................40

    5.1.1.1 Ruhsat ncesi Teknolojik Deerlendirme Birimi ....................................................................41

    5.1.1.2 Ruhsatl lalar Teknolojik Deerlendirme Birimi ...................................................................42

    NDEKLER

  • DARE FAALYET RAPORU / 2015

    IV

    5.1.1.3 Farmakolojik Deerlendirme Birimi ............................................................................................42

    5.1.1.4 Kilinik Deerlendirme Birimi ..........................................................................................................43

    5.1.1.5 Biyoyararlanm ve Biyoedeerlik Deerlendirme Birimi ...................................................44

    5.1.1.6 dari Ruhsatlandrma Birimi ...........................................................................................................44

    5.1.1.7 Ruhsatl lalar Birimi ........................................................................................................................45

    5.1.1.8 Biyolojik ve Biyoteknolojik rnler Birimi .................................................................................46

    5.1.1.9 Elektronik Veri Gncelleme Birimi ................................................................................................47

    5.1.1.10 Koordinasyon Birimi .......................................................................................................................47

    5.1.1.11 n nceleme (CTD) Birimi .............................................................................................................47

    5.1.2 Bitkisel Destek ve leri Tedavi Tbbi rnleri Daire Bakanl .................................................48

    5.1.2.1 leri Tedavi Tbbi rnleri Ruhsatlandrma Birimi .................................................................49

    5.1.2.2 leri Tedavi Tbbi rnleri Bireysel Bavuru deerlendirme Birimi .................................49

    5.1.2.3 Tbbi Beslenme rnleri Birimi .....................................................................................................49

    5.1.2.4 Geleneksel Bitkisel ve Homeopatik Tbbi rnler Birimi ....................................................49

    5.1.2.5 Farmastik rn Sertifikalandrma Birimi ...............................................................................50

    5.1.2.6 thalat Birimi ........................................................................................................................................50

    5.1.2.7 Aktarlar Birimi......................................................................................................................................50

    5.1.2.8 Salk Beyanl rnler Deerlendirme Birimi..........................................................................51

    5.1.3 Klinik Aratrmalar Dairesi Bakanl ..................................................................................................51

    5.1.3.1 Bilgilendirme ve Koordinasyon Birimi ........................................................................................51

    5.1.3.2 Uygunluk Deerlendirme Birimi ...................................................................................................52

    5.1.3.3 zleme ve Deerlendirme Birimi ..................................................................................................52

    5.1.4 Risk Ynetimi Dairesi Bakanl ............................................................................................................52

    5.1.4.1 Trkiye Farmakovijilans Merkezi (TFAM) ......................................................................................53

    5.1.4.2 Farmakovijilans Risk Ynetimi Birimi ................................................................................................54

    5.1.4.3 Uyuturucu ve Psikotrop Maddeler Kontrol Birimi ....................................................................

Search related