Izindaba

Izindlela ezintathu zokubuyisa izenzakalo ezimbi zedivayisi yezokwelapha

Isizindalwazi, igama lomkhiqizo kanye negama lomkhiqizi yizona zindlela ezintathu eziyinhloko zokuqapha izimo ezingezinhle zedivayisi yezokwelapha.

Ukutholwa kwezehlakalo ezimbi zedivayisi yezokwelapha kungenziwa ngokuya ngesizindalwazi, futhi izizindalwazi ezahlukene zinezimpawu zazo. Isibonelo, incwajana yolwazi lwezehlakalo ezimbi zedivayisi yezokwelapha yaseShayina ivame ukwazisa izehlakalo ezimbi zohlobo oluthile lwemikhiqizo, kuyilapho izehlakalo ezimbi zedivayisi yezokwelapha ezibhalwe encwadini yokuxwayisa ngedivayisi yezokwelapha zivela kakhulu e-United States, e-United Kingdom, e-Australia naseCanada. Idatha yesixwayiso noma yokukhumbula idivayisi yezokwelapha yasekhaya nesifunda akuyona idatha ebikiwe yasekhaya; isizindalwazi se-MAUDE sase-United States siyisizindalwazi esigcwele, inqobo nje uma izehlakalo ezimbi zedivayisi yezokwelapha ezibikwe ngokwemithethonqubo ye-FDA yase-United States zizofakwa kusizindalwazi; izizindalwazi ezihlobene nezehlakalo ezimbi zedivayisi yezokwelapha / ukukhunjulwa / ulwazi lokuxwayisa zamazwe nezifunda ezifana ne-United Kingdom, Canada, Australia neJalimane zizobuyekezwa njalo. Ukuze kutholakale izehlakalo ezimbi zedivayisi yezokwelapha ngokuya ngesizindalwazi, ingahlolwa ngokuya ngamagama angukhiye, futhi ingabuyekezwa ngokunembile ngokukhawulela isikhathi noma indawo yegama elingukhiye.

Ukuze wenze ukubuyisa izenzakalo ezimbi zedivayisi yezokwelapha ngokuya egameni lomkhiqizo, ungafaka igama lomkhiqizo wedivayisi yezokwelapha okulindelekile ekhasini lokubuyisa idathabheyisi ukuze ulibuyise, futhi ngokuvamile akudingeki ufake igama lomkhiqizo eliqondile kakhulu.

Uma usesha ngokwegama lebhizinisi ledivayisi yezokwelapha, uma ibhizinisi liyibhizinisi elixhaswe ngemali yangaphandle, kubalulekile ukunaka ukumelwa okuhlukile kwegama lebhizinisi, njenge-case, isifinyezo, njll.

Ukuhlaziywa kokutholwa kwezehlakalo ezimbi ezivela ezimweni ezithile

Okuqukethwe kombiko wocwaningo lokuqapha izehlakalo ezimbi zedivayisi yezokwelapha kungafaka kodwa kungagcini ngokubuka konke okufushane kwenhloso yokuqapha kanye nohlelo lokuqapha izehlakalo ezimbi zedivayisi yezokwelapha; ukuqapha imithombo yedatha; isikhathi sokutholwa kwezehlakalo ezimbi; inani lezehlakalo ezimbi; umthombo wemibiko; izimbangela zezehlakalo ezimbi; imiphumela yezehlakalo ezimbi; isilinganiso sezehlakalo ezahlukene ezimbi; izinyathelo ezithathwe zezehlakalo ezimbi; kanye; Idatha yokuqapha kanye nenqubo yokuqapha inganikeza ugqozi lokubuyekezwa kobuchwepheshe, ukuqapha imikhiqizo ngemuva kokumaketha, noma ukuphathwa kwezingozi zamabhizinisi okukhiqiza.

Ngenxa yenani elikhulu ledatha, izingcezu zolwazi ezingu-219 zatholakala ngokukhawulela "ikhodi yomkhiqizo" kuJuni 2019. Ngemva kokususa izingcezu ezingu-19 zolwazi olungeyona ingozi, izingcezu ezingu-200 ezisele zafakwa ekuhlaziyweni. Ulwazi oluku-database lukhishwa ngalunye ngalunye, kusetshenziswa isofthiwe ye-Microsoft Excel eqoqwe idatha emthonjeni wombiko, ulwazi oluhlobene nedivayisi yezokwelapha (kufaka phakathi igama lomenzi, igama lomkhiqizo, uhlobo lwedivayisi yezokwelapha, izinkinga zedivayisi yezokwelapha), isikhathi sokwenzeka kwezehlakalo ezimbi, isikhathi lapho i-FDA ithole khona izehlakalo ezimbi, uhlobo lwezehlakalo ezimbi, izimbangela zezehlakalo ezimbi, bese ihlaziya indawo yezehlakalo ezimbi. Izimbangela eziyinhloko zezehlakalo ezimbi zafingqwa, futhi izinyathelo zokuthuthukisa zabekwa phambili kusukela ezicini zokusebenza, ukwakheka kokufakelwa kanye nokunakekelwa ngemva kokuhlinzwa. Inqubo yokuhlaziya engenhla kanye nokuqukethwe kungasetshenziswa njengereferensi yokuhlaziywa kwezehlakalo ezifanayo ezimbi zedivayisi yezokwelapha.

Ukuhlaziywa kwezehlakalo ezimbi ukuthuthukisa izinga lokulawula ubungozi

Isifinyezo kanye nokuhlaziywa kwezehlakalo ezimbi zedivayisi yezokwelapha kunencazelo ethile ebhekiselayo eminyangweni yokulawula idivayisi yezokwelapha, amabhizinisi okukhiqiza nokusebenza kanye nabasebenzisi ukuze benze ukulawula ubungozi. Emnyangweni wokulawula, ukwakhiwa nokubuyekezwa kwemithethonqubo yedivayisi yezokwelapha, imithetho kanye nemibhalo ejwayelekile kungenziwa kanye nemiphumela yokuhlaziya yezehlakalo ezimbi, ukuze kwenziwe ukulawulwa kwengozi kanye nokuphathwa kwemishini yezokwelapha kube nemithetho nemigomo okufanele ilandelwe. Qinisa ukubhekwa ngemuva kokumaketha kwemishini yezokwelapha, uqoqe futhi ufingqe izehlakalo ezimbi, uxwayise futhi ukhumbule ulwazi lwemishini yezokwelapha njalo, bese ukhipha isimemezelo ngesikhathi. Ngesikhathi esifanayo, qinisa ukubhekwa kwabakhiqizi bemishini yezokwelapha, yenza inqubo yabo yokukhiqiza ibe yijwayelekile, futhi unciphise ngempumelelo amathuba ezehlakalo ezimbi ezivela emthonjeni. Ngaphezu kwalokho, kufanele siqhubeke nokukhuthaza ucwaningo lwesayensi mayelana nokubhekwa kwemishini yezokwelapha futhi sakhe uhlelo lokuhlola olusekelwe ekulawulweni kwengozi okunembile.

Izikhungo zezokwelapha kufanele ziqinise ukuqeqeshwa nokuphathwa, ukuze odokotela bakwazi ukuqonda izidingo zokusebenza ezijwayelekile kanye namakhono okusebenza kwemishini, futhi banciphise amathuba ezenzakalo ezimbi. Ukuqinisa inhlanganisela yezokwelapha kanye nobunjiniyela, kanye nokunxusa odokotela ukuthi baxhumane nonjiniyela bokuklama amadivayisi ezokwelapha ngezinkinga ezitholakala ekusetshenzisweni kwezokwelapha kwamadivayisi ezokwelapha, ukuze odokotela bakwazi ukuqonda kabanzi ngamadivayisi ezokwelapha asetshenziswayo, futhi basize onjiniyela bokuklama amadivayisi ezokwelapha ukuthi baklame noma bathuthukise kangcono amadivayisi ezokwelapha. Ngaphezu kwalokho, isiqondiso sokuvuselelwa kwezokwelapha kufanele siqiniswe ukuze kukhunjuzwe iziguli ngamaphuzu abalulekile okuvimbela ukwehluleka kwangaphambi kwesikhathi kokufakelwa ngenxa yemisebenzi yangaphambi kwesikhathi noma ukusebenza okungafanele. Ngesikhathi esifanayo, odokotela kufanele bathuthukise ukuqwashisa kwabo ngezenzakalo ezimbi zamadivayisi ezokwelapha, bagweme ingozi yokusetshenziswa kwamadivayisi ezokwelapha, futhi baqoqe futhi babike ngesikhathi esifanele izenzakalo ezimbi zamadivayisi ezokwelapha.