[關(guān)鍵詞]
[摘要]
藥物非臨床研究質(zhì)量管理規(guī)范(GLP)實(shí)施中最主要、最關(guān)鍵的環(huán)節(jié)是人員。人員的GLP意識(shí)、專業(yè)技術(shù)能力的培養(yǎng)至關(guān)重要,因此GLP機(jī)構(gòu)中人員的教育培訓(xùn)工作應(yīng)貫穿于整個(gè)職業(yè)生涯。通過對(duì)當(dāng)前GLP機(jī)構(gòu)中人員培訓(xùn)存在的問題及培訓(xùn)的重要性進(jìn)行總結(jié),從培訓(xùn)分類、培訓(xùn)要求及國(guó)內(nèi)外現(xiàn)狀等方面進(jìn)行比較與討論,闡明唯有切實(shí)有效的培訓(xùn)方能為GLP機(jī)構(gòu)培養(yǎng)有資質(zhì)的合格人員,使人員具有正確的法規(guī)理念和GLP意識(shí)、扎實(shí)的專業(yè)知識(shí)、熟練的操作技能、優(yōu)秀的團(tuán)隊(duì)意識(shí),才能從根本上提高藥物臨床前安全性評(píng)價(jià)質(zhì)量并促進(jìn)GLP機(jī)構(gòu)長(zhǎng)足發(fā)展。
[Key word]
[Abstract]
The personnel is the most important and key point in Good Laboratory Practice (GLP) for non-clinical laboratory studies. The GLP awareness and professional and technical ability training is very important, so the education and training of personnel in GLP facilities should run through the whole career life. Based on the problems and importance for the personnel training, and compared with the training type, training requirements, and domestic and foreign status, it is clarified that only effective training may train qualified personnel for GLP facilities. The personnel with correct regulation idea and GLP awareness, solid professional knowledge, proficient operating skills, and excellent team spirit could fundamentally improve the rapid development of preclinical drug safety evaluation quality and GLP facilities.
[中圖分類號(hào)]
[基金項(xiàng)目]