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 ....................................................................