{"id":22793,"date":"2022-05-13T12:21:34","date_gmt":"2022-05-13T12:21:34","guid":{"rendered":"https:\/\/www.esin.av.tr\/?p=22793"},"modified":"2022-06-09T13:41:56","modified_gmt":"2022-06-09T13:41:56","slug":"farmakovijilans-uygulamalari-kilavuzu-egitim-materyalleri-ile-guvenlilik-iletisimi-ve-farmakovijilans-faaliyetlerinde-kriz-yonetimi-rehberi-yayimlandi","status":"publish","type":"post","link":"https:\/\/www.esin.av.tr\/tr\/2022\/05\/13\/farmakovijilans-uygulamalari-kilavuzu-egitim-materyalleri-ile-guvenlilik-iletisimi-ve-farmakovijilans-faaliyetlerinde-kriz-yonetimi-rehberi-yayimlandi\/","title":{"rendered":"Farmakovijilans Uygulamalar\u0131 K\u0131lavuzu E\u011fitim Materyalleri ile G\u00fcvenlilik \u0130leti\u015fimi ve Farmakovijilans Faaliyetlerinde Kriz Y\u00f6netimi Rehberi yay\u0131mland\u0131"},"content":{"rendered":"<p><strong><a href=\"https:\/\/podcast.esin.av.tr\/?lang=tr&amp;playing=PFC4512569199?updated=1652434043\" target=\"_blank\" rel=\"noopener\"><img decoding=\"async\" class=\"alignnone wp-image-18799\" src=\"https:\/\/www.esin.av.tr\/wp-content\/uploads\/2021\/02\/1.png\" alt=\"\" width=\"41\" height=\"41\" srcset=\"https:\/\/www.esin.av.tr\/wp-content\/uploads\/2021\/02\/1.png 186w, https:\/\/www.esin.av.tr\/wp-content\/uploads\/2021\/02\/1-150x150.png 150w\" sizes=\"(max-width: 41px) 100vw, 41px\" \/><\/a>\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0Bu b\u00fcltenimizi podcast olarak da dinleyebilirsiniz!<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p>T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (&#8220;<strong>Kurum<\/strong>&#8220;) ge\u00e7ti\u011fimiz haftalarda (i) Farmakovijilans Uygulamalar\u0131 (\u0130FU) K\u0131lavuzu Mod\u00fcl IX EK I \u2013 E\u011fitim Materyalleri ile Mod\u00fcl VIII \u2013 G\u00fcvenlilik \u0130leti\u015fimi&#8217;ni ve (ii) Farmakovijilans Faaliyetlerinde Kriz Y\u00f6netimi Rehberi&#8217;ni yay\u0131mlad\u0131.<\/p>\n<p>G\u00fcncel geli\u015fmeler \u00f6zelindeki notlar\u0131m\u0131za a\u015fa\u011f\u0131daki linklerden ula\u015fabilirsiniz:<\/p>\n<p><a href=\"#tr1\"><strong>\u0130yi Farmakovijilans Uygulamalar\u0131 (\u0130FU) K\u0131lavuzu Mod\u00fcl IX EK I \u2013 E\u011fitim Materyalleri ve Mod\u00fcl VIII \u2013 G\u00fcvenlilik \u0130leti\u015fimi Ne Getirmektedir?<\/strong><\/a><br \/>\n<a href=\"#tr2\"><strong>Farmakovijilans Faaliyetlerinde Kriz Y\u00f6netimi Rehberi Ne Getirmektedir?<\/strong><\/a><\/p>\n<p><strong>\u0130yi Farmakovijilans Uygulamalar\u0131 (\u0130FU) K\u0131lavuzu Mod\u00fcl IX EK I \u2013 E\u011fitim Materyalleri ve Mod\u00fcl VIII \u2013 G\u00fcvenlilik \u0130leti\u015fimi Ne Getirmektedir?<\/strong><\/p>\n<p><strong>Yeni Geli\u015fme<\/strong><br \/>\nKurum, 27 Nisan 2022 tarihinde, \u0130yi Farmakovijilans Uygulamalar\u0131 (\u0130FU) K\u0131lavuzu Mod\u00fcl IX EK I \u2013 E\u011fitim Materyalleri ile Mod\u00fcl VIII \u2013 G\u00fcvenlilik \u0130leti\u015fimi&#8217;ni yay\u0131mlad\u0131.<\/p>\n<p>\u0130yi Farmakovijilans Uygulamalar\u0131 (\u0130FU) K\u0131lavuzu Mod\u00fcl IX EK I \u2013 E\u011fitim Materyalleri&#8217;ne <a href=\"https:\/\/urldefense.com\/v3\/__https:\/esinxchange.com\/collect\/click.aspx?u=dHlja09CTzN4ZXBFU2IvY3I4bVFqUDBhWDJ0a0pLRXFObkc4UkhEWkc1d1loZ1kyeEF0ZmRFVmdpMW1ZRXdFNFNpZEUxR0F5RWpDWUpsYmttQUxjblhrSEpTVFZ4YUI3RHpKSkFMVGhzd2VTam5nVnBRb3NTQ3JzUHlJKzhYUk5iUFN6eUQ3dTRvRT0=&amp;rh=ff0090bb9bafab459bc1f73b664884300c21bea2__;!!Hj9Y_P0nvg!TRILNmGLEgD7nOI2wKezN_mT-lWHNxdF3bRil-jgE6Pod8XCre9IKjP6Him7xgJuDay-WNz-K78qjTqI1oBIjXg6Ug$\">buradan<\/a> ula\u015fabilirsiniz.<\/p>\n<p>\u0130yi Farmakovijilans Uygulamalar\u0131 (\u0130FU) K\u0131lavuzu Mod\u00fcl VIII \u2013 G\u00fcvenlilik \u0130leti\u015fimi&#8217;ne <a href=\"https:\/\/urldefense.com\/v3\/__https:\/esinxchange.com\/collect\/click.aspx?u=dHlja09CTzN4ZXBFU2IvY3I4bVFqUDBhWDJ0a0pLRXFObkc4UkhEWkc1d1loZ1kyeEF0ZmRFVmdpMW1ZRXdFNFNpZEUxR0F5RWpEbTAyZHdVVTNkcnl6SUZSY0JsK3hZNXR4UHpCN1BESm1Ob2ZWMmVGTmVVUjhtUjd6YTVxL3NRSU5DRmZlaWkxTUIrUTdOMnJSWElRPT0=&amp;rh=ff0090bb9bafab459bc1f73b664884300c21bea2__;!!Hj9Y_P0nvg!TRILNmGLEgD7nOI2wKezN_mT-lWHNxdF3bRil-jgE6Pod8XCre9IKjP6Him7xgJuDay-WNz-K78qjTqI1oB6f94y-Q$\">buradan <\/a>ula\u015fabilirsiniz.<\/p>\n<p><strong>Ne De\u011fi\u015fecek?<\/strong><\/p>\n<p><em>\u0130yi Farmakovijilans Uygulamalar\u0131 (\u0130FU) K\u0131lavuzu Mod\u00fcl IX EK I \u2013 E\u011fitim Materyalleri<\/em><\/p>\n<p>K\u0131lavuz, taslak e\u011fitim materyallerinin Kurum\u2019a sunulmas\u0131nda ruhsat sahiplerine rehberlik etmeyi ama\u00e7lamaktad\u0131r. K\u0131lavuz&#8217;da yer alan ba\u015fl\u0131ca d\u00fczenlemeler a\u015fa\u011f\u0131daki gibidir:<\/p>\n<ul>\n<li>E\u011fitim materyalleri, il\u00e2ve risk minimizasyon (aRMM) \u00f6nlemi olarak \u00f6nemli bir riski en aza indirmeyi ve\/veya bir t\u0131bbi \u00fcr\u00fcn\u00fcn yarar-risk dengesini en \u00fcst d\u00fczeye \u00e7\u0131karmay\u0131 ama\u00e7lar. E\u011fitim materyali; k\u0131sa \u00fcr\u00fcn bilgileri, kullanma talimat\u0131 ve ambalajda yer alan \u00fcr\u00fcn bilgileriyle uyumlu olmal\u0131 ve yeni bilgiler sa\u011flamal\u0131d\u0131r.<\/li>\n<li>Ruhsat sahibi, e\u011fitim materyalinin hedef kitleye uygun olmas\u0131, \u00f6rt\u00fcl\u00fc tan\u0131t\u0131mlar i\u00e7ermemesi, risk minimizasyon hedeflerini sa\u011flamas\u0131 ve uygun d\u00fczen ve bi\u00e7imde olmas\u0131 gibi ilkeleri sa\u011flamal\u0131d\u0131r.<\/li>\n<li>E\u011fitim materyali, d\u00fczenleyici prosed\u00fcre ba\u011fl\u0131 olarak, AB veya Kurum ile kararla\u015ft\u0131r\u0131lan ve ruhsatland\u0131rma ko\u015fullar\u0131nda yer alan temel unsurlar\u0131n mesajlar\u0131n\u0131 i\u00e7ermelidir. E\u011fitim materyalinde detayl\u0131 bilgi i\u00e7in internet sitesine y\u00f6nlendirme yap\u0131labilmesi Kurum&#8217;un onay\u0131yla m\u00fcmk\u00fcnd\u00fcr.<\/li>\n<li>E\u011fitim materyalinde g\u00f6rsel ve grafikler metnin yeterli olmad\u0131\u011f\u0131 hallerde kullan\u0131lmal\u0131 ve tan\u0131t\u0131m ama\u00e7l\u0131 olmamal\u0131d\u0131r.<\/li>\n<li>Kurum veya ruhsat sahibi taraf\u0131ndan farkl\u0131 bir e\u011fitim materyali \u00f6nerilmedik\u00e7e ruhsat sahibi, Avrupa \u0130la\u00e7 Ajans\u0131 (EMA) taraf\u0131ndan onaylanan e\u011fitim materyalini Kurum onay\u0131ndan sonra T\u00fcrkiye&#8217;de uygulamal\u0131d\u0131r. E\u011fitim materyalleri, k\u0131lavuzda yer alan bilgi ve belgelerle Kurum onay\u0131na sunulabilecektir.<\/li>\n<li>Bir etkin madde i\u00e7in ilk ba\u015fvuruya istinaden haz\u0131rlanan e\u011fitim materyali Kurum taraf\u0131ndan onayland\u0131ktan sonra Kurum&#8217;un internet sitesinde il\u00e2n edilecek olup ayn\u0131 etkin madde i\u00e7in sonradan yap\u0131lan ba\u015fvurular\u0131n il\u00e2n edilen materyaller \u00fczerinden haz\u0131rlanmas\u0131 Kurum onay\u0131na sunulmas\u0131 gerekir.<\/li>\n<li>Kurum, e\u011fitim materyalini ortalama 60 g\u00fcn i\u00e7erisinde de\u011ferlendirerek onaylad\u0131\u011f\u0131 e\u011fitim materyallerini internet sitesinde yay\u0131nlayacakt\u0131r.<\/li>\n<\/ul>\n<p><em>\u0130yi Farmakovijilans Uygulamalar\u0131 (\u0130FU) K\u0131lavuzu Mod\u00fcl VIII \u2013 G\u00fcvenlilik \u0130leti\u015fimi<\/em><\/p>\n<p>\u0130la\u00e7 g\u00fcvenlili\u011fine ili\u015fkin bilgi, ileti\u015fim ve koordinasyon hususunda ruhsat sahiplerine rehberlik etmeyi ama\u00e7layan K\u0131lavuz&#8217;da yer alan ba\u015fl\u0131ca d\u00fczenlemeler a\u015fa\u011f\u0131daki gibidir:<\/p>\n<ul>\n<li>G\u00fcvenlilik bilgilerinin hastalara ve sa\u011fl\u0131k mesle\u011fi mensuplar\u0131na duyurulmas\u0131; farmakovijilans faaliyeti kapsam\u0131nda ila\u00e7lar\u0131n do\u011fru, g\u00fcvenli ve etkili kullan\u0131m\u0131n\u0131n sa\u011flanmas\u0131, advers reaksiyonlardan do\u011fabilecek zararlar\u0131n \u00f6nlenmesi, risklerin azalt\u0131lmas\u0131 ve hasta ve halk sa\u011fl\u0131\u011f\u0131n\u0131n korunmas\u0131 i\u00e7in gereklidir.<\/li>\n<li>\u0130la\u00e7 g\u00fcvenlili\u011fi ile ilgili bilgilerin amac\u0131na uygun, a\u00e7\u0131k, do\u011fru ve tutarl\u0131 olmas\u0131, risk ve g\u00fcvenlilik endi\u015fesine ili\u015fkin a\u00e7\u0131klamalar i\u00e7ermesi, gerekiyorsa hastalara ve sa\u011fl\u0131k mesle\u011fi mensuplar\u0131na dan\u0131\u015f\u0131lmas\u0131, bilginin \u00f6n teste t\u00e2bi tutulmas\u0131 ve hedef kitleye zaman\u0131nda ula\u015ft\u0131r\u0131lmas\u0131 gibi gereklilikleri sa\u011flamas\u0131 gerekmektedir.<\/li>\n<li>G\u00fcvenlilik duyurusunda; ilac\u0131n yarar\/risk dengesine ili\u015fkin \u00f6nemli yeni bilgiler, g\u00fcvenlilik ileti\u015fiminin nedeni, \u00fcr\u00fcn bilgilerinde yap\u0131lmas\u0131 \u00f6nerilen de\u011fi\u015fiklikler ve \u015f\u00fcpheli advers reaksiyonlar\u0131n T\u00fcrkiye Farmakovijilans Merkezi\u2019ne (T\u00dcFAM) bildirilmesi gibi a\u00e7\u0131klamalara yer verilmelidir.<\/li>\n<li>G\u00fcvenlik duyurusu sa\u011fl\u0131k mesle\u011fi mensuplar\u0131yla do\u011frudan ileti\u015fime ge\u00e7ilerek, Kurum arac\u0131l\u0131\u011f\u0131yla, bas\u0131n b\u00fcltenleri, yay\u0131nlar, sosyal medya veya internet sitesi gibi ara\u00e7lar \u00fczerinden yap\u0131labilecektir.<\/li>\n<li>Sa\u011fl\u0131k mesle\u011fi mensuplar\u0131na y\u00f6nelik bilgilendirme mektuplar\u0131, ilac\u0131n uygun kullan\u0131m ko\u015fullar\u0131na etkisi olmayan \u00fcr\u00fcn bilgisi de\u011fi\u015fiklikleri gibi sa\u011fl\u0131k mesle\u011fi mensuplar\u0131na bireysel olarak iletilmesi gerekmeyen bilgilerin yay\u0131lmas\u0131nda ve tan\u0131t\u0131m\/ticari ama\u00e7l\u0131 kullan\u0131lmamal\u0131d\u0131r.<\/li>\n<\/ul>\n<p><strong>Farmakovijilans Faaliyetlerinde Kriz Y\u00f6netimi Rehberi Ne Getirmektedir?<\/strong><\/p>\n<p><strong>Yeni Geli\u015fme<\/strong><\/p>\n<p>Kurum, 27 Nisan 2022 tarihinde, Farmakovijilans Faaliyetlerinde Kriz Y\u00f6netimi Rehberi&#8217;ni yay\u0131mlad\u0131. Rehberde kriz ve risk tan\u0131m\u0131, \u00f6zellikleri, payda\u015flar\u0131n yapmas\u0131 gerekenler, kriz ve risk analizi \u00f6rnekleri, kriz y\u00f6netim \u015femalar\u0131 ve ileti\u015fim becerileri gibi a\u00e7\u0131klamalara yer verilmi\u015ftir.<\/p>\n<p>Rehber&#8217;e <a href=\"https:\/\/urldefense.com\/v3\/__https:\/esinxchange.com\/collect\/click.aspx?u=dHlja09CTzN4ZXBFU2IvY3I4bVFqUDBhWDJ0a0pLRXFObkc4UkhEWkc1ekpERUlvYml0bWtGenJNZW0zQ2l3SWtLVHNGNWVGQjNMRTFDMjBvd2k0QTVkMnUwTHF2ckY4aW5KdE1pQkNrVG5KSUpaS0NGZS9nRGJlbVorZDF5bUFOQ2MrcjdLdXBHY2grd0lET1RqS0ZKNHA0RW4xR2tibnp5cXh5OU5saE8wcHYvbWRmdnB4eXRQZzFuT2lXQ082eUUxQm1VbXdqbUVhc0xTbzBwTmhnOGFleFFTMVlBZWxpem1SVlM0eTNjND0=&amp;rh=ff0090bb9bafab459bc1f73b664884300c21bea2__;!!Hj9Y_P0nvg!TRILNmGLEgD7nOI2wKezN_mT-lWHNxdF3bRil-jgE6Pod8XCre9IKjP6Him7xgJuDay-WNz-K78qjTqI1oArIppC0g$\">buradan <\/a>ula\u015fabilirsiniz.<\/p>\n<p><strong>Ne De\u011fi\u015fecek?<\/strong><\/p>\n<p><em>Kriz ve kriz y\u00f6netimi<\/em><\/p>\n<p>Rehber uyar\u0131nca kriz; bir organizasyonun normal faaliyetlerinin sekteye u\u011framas\u0131na veya istikrar\u0131n\u0131 yitirmesine yol a\u00e7an planlanmam\u0131\u015f bir durum veya izleyen durumlar dizini olarak tan\u0131mlanm\u0131\u015ft\u0131r. Rehber, organizasyonlar\u0131n kriz haline ili\u015fkin \u00f6nceden tan\u0131mlanm\u0131\u015f e\u015fikleri olmas\u0131 ve ger\u00e7ekle\u015fmesi halinde kriz y\u00f6netim plan\u0131n\u0131n uygulanmas\u0131 gerekti\u011fini d\u00fczenlemektedir. Kriz y\u00f6netimi kapsam\u0131nda, organizasyonlar\u0131n d\u0131\u015f \u00a0payda\u015flarla i\u015fbirli\u011fi i\u00e7inde krizleri \u00f6nleyebilmesi veya ortaya \u00e7\u0131kan krizleri etkin bi\u00e7imde y\u00f6netebilmesi gerekmektedir. Kriz y\u00f6netiminde temel ama\u00e7 ise krizlerin tahmin edilmesi ve krizlerden ka\u00e7\u0131n\u0131lmas\u0131d\u0131r.<br \/>\nKriz halinde;<\/p>\n<ul>\n<li>t\u00fcm taraflar i\u00e7in ba\u015far\u0131\/ba\u015far\u0131s\u0131zl\u0131k dengesinin lehte olmas\u0131n\u0131n sa\u011flanmas\u0131,<\/li>\n<li>kriz esnas\u0131nda ve krizden sonra i\u015f kapasitesinin ve devaml\u0131l\u0131\u011f\u0131n korunmas\u0131 ve<\/li>\n<li>benzer olaylar\u0131n gelecekte de meydana gelmesini engellemeye veya s\u00f6z konusu olaylarla daha etkili m\u00fccadele yollar\u0131n\u0131n bulunmas\u0131 hedeflenmelidir.<\/li>\n<\/ul>\n<p>Kriz y\u00f6netim planlamas\u0131; krize haz\u0131rl\u0131k, organizasyonun t\u00fcm b\u00f6l\u00fcm ve d\u00fczeylerinden gelen y\u00f6netici grubundan olu\u015fan stratejik kriz planlama ekibinin kurulmas\u0131, krizi \u00f6nleme hedefli istihbarat toplanmas\u0131, genel risk de\u011ferlendirmesi ve e\u011fitimlerin yap\u0131lmas\u0131 gibi a\u015famalardan olu\u015fmaktad\u0131r.<\/p>\n<p><em>Risk ve risk y\u00f6netimi<\/em><\/p>\n<p>Rehber uyar\u0131nca risk; ileride sonu\u00e7lar\u0131 olumsuz olacak olaylarla kar\u015f\u0131 kar\u015f\u0131ya kalma ihtimali olarak tan\u0131mlanm\u0131\u015ft\u0131r. Rehber, organizasyonlar\u0131n riskleri niteliksel ve niceliksel olarak belirleyerek potansiyel etkilerini de\u011ferlendirmeleri ve risk olas\u0131l\u0131\u011f\u0131n\u0131 veya etkisini azaltmak amac\u0131yla, analiz sonucu ortaya \u00e7\u0131kan risklere \u00e7\u00f6z\u00fcm plan\u0131 getirmeleri gerekti\u011fini d\u00fczenlemektedir.<\/p>\n<p>Risk analizi; (i) t\u00fcm olas\u0131 tehditlerin tespiti, (ii) risklerin olas\u0131l\u0131klar\u0131n\u0131n ve sonu\u00e7lar\u0131n\u0131n tahmini ve (iii) riskin do\u011fru bir perspektife yerle\u015ftirilmesi, planlama ve eylem i\u00e7in risk senaryolar\u0131na \u00f6ncelik verilmesi \u015feklinde 3 a\u015famadan olu\u015fmaktad\u0131r.<\/p>\n<p><em>\u0130leti\u015fim<\/em><\/p>\n<p>Rehber, kriz an\u0131nda organizasyonlar\u0131n sahip olmas\u0131 gereken ileti\u015fim becerilerini detayl\u0131 olarak d\u00fczenleyerek ileti\u015fimin a\u00e7\u0131k, dengeli d\u00fcr\u00fcst ve belirli bir konuya odakl\u0131 olmas\u0131 gerekti\u011fini vurgulamaktad\u0131r. Bu kapsamda, u\u011franacak zararlar\u0131n azalt\u0131lmas\u0131 ve en h\u0131zl\u0131 \u015fekilde \u00e7\u00f6z\u00fcm bulunabilmesi ad\u0131na sa\u011fl\u0131k mesle\u011fi mensuplar\u0131, ila\u00e7 \u015firketleri, t\u00fcketiciler ve bask\u0131 gruplar\u0131 gibi t\u00fcm kitlelere y\u00f6nelik etkili ileti\u015fim plan\u0131 yap\u0131lmal\u0131d\u0131r.<\/p>\n<p><strong>Sonu\u00e7<\/strong><\/p>\n<p>Kurum sa\u011fl\u0131k sekt\u00f6r\u00fcnde faaliyet g\u00f6steren \u015firketlere rehberlik etmeye devam etmektedir. Sa\u011fl\u0131k sekt\u00f6r\u00fcnde faaliyet g\u00f6steren t\u00fcm ilgili \u015firketler, Kurum&#8217;un duyurular\u0131n\u0131 yak\u0131ndan takip etmeli ve mevzuatta yer alan y\u00fck\u00fcml\u00fcl\u00fcklerini Kurum&#8217;un y\u00f6nlendirmeleri do\u011frultusunda yerine getirmelidir.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0Bu b\u00fcltenimizi podcast olarak da dinleyebilirsiniz! &nbsp; T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (&#8220;Kurum&#8220;) [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_stopmodifiedupdate":false,"_modified_date":"","footnotes":""},"categories":[120],"tags":[92],"class_list":["post-22793","post","type-post","status-publish","format-standard","hentry","category-legal-alerts","tag-healthcare-tr"],"acf":[],"yoast_head":"<!-- This site is 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