Kubva 31 Gumiguru kusvika 1 Mbudzi 2023, iyo 2nd Boao International Pharmaceutical and Device Real World Research Conference yakaitwa zvakabudirira muBoao, Hainan.Nedingindira re "International Real-World Data Research uye Scientific Development of Pharmaceutical and Device Regulation", musangano uyu waisanganisira plenary session uye masere parallel sub-forums pamusoro penyika chaiyo yekutsvaga data uye mutemo wezvinodhaka, mutemo wemidziyo yekurapa, uye mutemo we mishonga yechivanhu yechiChinese.
Kubva 2018, Medical Device Technical Review Center yeState Drug Administration (inozonzi Center) yakaita tsvakiridzo yedhata yepasirese mumunda wemidziyo yekurapa, ichifambisa nzira yekushandisa humbowo hwepasirese kubatsira mukiriniki. kuongorora, nekusimudzira kubvumidzwa uye kushambadzira kwezvishandiso zvekurapa zvakati wandei zvinodikanwa nekukurumidza.2021 Muna Chivabvu 2021, Center yakatungamira tsvakiridzo yeInternational Medical Devices Regulators' Forum (IMDRF) paMuna Chivabvu 2021, iyo IMDRF inotungamirwa. kudzidza "Post-market Clinical Follow-up of Medical Devices" yakasunungurwa, ichikurudzira zvinodiwa pane zvinyorwa zvemashoko, kuongororwa kwehutano, dhizaini yekudzidza uye kuongororwa kwenhamba yekushandiswa kwedata renyika chaiyo mune post-market kliniki yekutevera zvidzidzo, uye kutungamira mukuunza dhata repasi rose mumagwaro ekudyidzana kwenyika dzeIMDRF.Iyo Center yakatungamirawo mukugadzira akati wandei epasi rose magwaro ekudyidzana pakuongororwa kwekiriniki uye nekuashandura kuita magwaro ehunyanzvi ehunyanzvi muChina, pakutanga achigadzira hurongwa hwemitemo inotungamira yekuongororwa kwekiriniki yemidziyo yekurapa.Iyo Center yakaramba ichikurudzira kushandiswa kwehumbowo hwepasirese hwekunyoreswa kwechigadzirwa, nemhedzisiro inoshamisa.Kusvika parizvino, mabheji maviri emhando gumi nenhatu akaverengerwa mukuyedza kushandisa data renyika chaiyo yemidziyo yekurapa, iyo mhando nomwe dzine huwandu hwezvigadzirwa zvipfumbamwe zvakatenderwa kushambadzira.
Nemamwe marudzi ekutyaira akatenderwa kushambadzira, iyo Center iri kuongorora mashandisirwo echokwadi-renyika data yezvishandiso zvekurapa nguva dzose.Muna Kubvumbi gore rino, iyo Center for Instrumental Ongororo, pamwe neHainan Provincial Drug Administration uye Administration yeHainan Boao LeCheng International Medical Tourism Advance Zone, vakabatana vakapa "Matanho ekuita eKuitwa kweClinical Real-World Data Application yeMedical Devices. muHainan Boao LeCheng International Medical Tourism Advance Zone (yeMuedzo Implementation)”.Parizvino, mhando pfumbamwe dzakapinda zviri pamutemo pre-communication chiteshi.
Mune ramangwana, Instrument Ongororo Center ichashingairira kusimudzira kutsvagisa uye kushandiswa kwedata repasirese pasi pehurongwa hwekuvaka yemazuva ano yekuongorora system version 2.0, uye nekuvandudza basa rehumbowo hwepasirese mukuongororwa kwemidziyo yekurapa, kunyanya. zvigadzirwa zvine njodzi uye zvigadzirwa zvitsva.
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Nguva yekutumira: Nov-16-2023