Kusukela ngomhla zingama-31 ngo-Okthoba kuya ku-1 Novemba 2023, i-2nd BOAO International Pharmaceutical kanye nedivaysi ye-Real World Research Conference yagcinwa ngempumelelo eBoao, Hainan. Ngengqikithi yocwaningo lwe- "International Real-World Data Research kanye nokuthuthukiswa kwesayensi kwemithetho yezemithi kanye nedivayisi", ingqungquthela ifaka phakathi iseshini yokuhlangana eyisishiyagalombili ngocwaningo lwedatha yangempela yomhlaba kanye nokulawulwa kwezidakamizwa, kanye nomthethonqubo we umuthi wendabuko waseChina.
Kusukela ngo-2018, isikhungo sezokwelapha sokubuyekezwa kwezobuchwepheshe se-State Drug Administration (sanawa nalapha okubhekiselwe esikhungweni) senze ucwaningo lwedatha yangempela emkhakheni wamadivayisi wezokwelapha, ukuthola indlela yokusebenzisa ubufakazi bangempela emhlabeni ukusiza emtholampilo Ukuhlola, nokukhuthaza ukuvunywa kanye nokumaketha kwenqwaba yezindlela zokwelashwa ezingeniswa emtholampilo ezivumayo. Ukutadisha "Ukulandelwa kwemitholampilo ngemuva kwemitholampilo yamamakethe" kukhishwe, kuhlongoza izidingo zemithombo yedatha, ukuhlolwa kwekhwalithi, ukwakheka kwezibalo kanye nokuhlaziywa kwezibalo kokusetshenziswa kwedatha yangempela yomphakathi ezimakethe, futhi Ukuthatha ukuhola ekwethuleni idatha yangempela yomhlaba kumadokhumenti okuxhumana kwamazwe omhlaba we-IMDRF. Lesi sikhungo siphinde sahola ekuhleleni amadokhumenti okuxhumana ngamanye amazwe ekuhlolweni kwemitholampilo nasekuziguquleleni kumadokhumenti okujwayelekile kwezobuchwepheshe eChina, ekuqaleni wakhela uhlelo lwemigomo eqondisayo ejwayelekile yokuhlolwa kwemitholampilo kwamadivayisi wezokwelapha amadivaysi ezokwelapha. Lesi sikhungo siqhubeke nokukhuthaza ukusetshenziswa kobufakazi bangempela bomhlaba wokubhalisa umkhiqizo, ngemiphumela emangalisayo. Kuze kube manje, ama-batches amabili ezinhlobonhlobo eziyi-13 afakiwe ku-Pilot application yemininingwane yangempela yomhlaba yamadivayisi wezokwelapha, okuyiyo izinhlobo eziyisikhombisa ezivunyelwe yimikhiqizo eyisishiyagalolunye evunyelwe yokumaketha.
Ngezinhlobo eziningi zokushayela izindiza ezivunyelwe ukumaketha, isikhungo sihlola ukusetshenziswa kwedatha yangempela yomhlaba yamadivayisi wezokwelapha njalo. Ngo-Ephreli kulo nyaka, isikhungo sokubuyekezwa kwezidakamizwa, kanye nokuphathwa kwezidakamizwa esifundazweni saseHainan kanye nokuphathwa kweHainan BOAO Lecheng International Medical Tourism South Courism Zoverance Advance Zovene Advance Zone, EHainan BOAO Lecheng International Medical Medical Tourism Zone Advance Zone (ngokuqaliswa kwesilingo) ". Njengamanje, izinhlobo eziyisishiyagalolunye zingene ngokusemthethweni isiteshi sangaphambi kwezokuxhumana.
Esikhathini esizayo, isikhungo sokuhlola izinsimbi sizokhuthaza ngokwenza umsebenzi wokucwaninga kanye nokusetshenziswa kwemininingwane yangempela yomhlaba ngaphansi kohlaka lokwakha uhlelo lwanamuhla lwenguqulo engu-2.0, futhi kuthuthukise ukuqhamuka iqhaza lobufakazi bangempela bezwe ekuhlolweni kwamadivayisi wezokwelapha, ikakhulukazi Imikhiqizo enobungozi obukhulu nemikhiqizo emisha.
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Isikhathi sePosi: Nov-16-2023