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關于ICH舉辦指導原則《E6(R3):藥物臨床試驗質量管理規范》線上公開會議的通知

來源:NMPA CDE  發布時間:2021-05-13  瀏覽量:470

       2021年4月19日,國際人用藥品注冊技術協調會(ICH)發布了正在起草中的《E6(R3):藥物臨床試驗質量管理規范》(Good Clinical Practice)原則文件的工作稿。
       由于《E6(R3):藥物臨床試驗質量管理規范》(Good Clinical Practice)具有廣泛且重大的影響,為增加透明度和建立共識,E6(R3)專家工作組(EWG)計劃在2021年5月18日(美國東部時間早8點至11點,北京時間18日晚8點至11點)和19日(美國東部時間早5點至8點,北京時間19日晚5點至8點)舉辦2場內容相近的線上公開會議,介紹該指導原則修訂工作的進展。會議由臨床試驗轉型倡議(Clinical Trials Transformation Initiative,CTTI)承辦?,F將ICH通知轉發如下,請感興趣的人員按照通知要求自行選擇參加。
       ICH會議通知鏈接:
       https://www.ich.org/page/ich-public-events#1-2
       ICH會議報名鏈接:
       18日:
       https://duke.zoom.us/webinar/register/WN_6MVjr6qsQxSgYrCuJ-6Xyw
       19日:
       https://duke.zoom.us/webinar/register/WN_OzK4XPh_Shq-XniAxpKKJw
       會議日程安排:
       https://admin.ich.org/sites/default/files/inline-files/ICH_E6R3_WebConference_Agenda_ForPublication_2021_0504.pdf
       ICH E6(R3)原則文件初稿:
       https://database.ich.org/sites/default/files/ICH_E6-R3_GCP-Principles_Draft_2021_0419.pdf
       如有問題,可直接聯系會議主辦方(聯系方式詳見ICH會議報名鏈接)。
                                                                                                                                         ICH工作辦公室
                                                                                                                                         2021年5月13日

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