【喜讯】丰县人民医院药物临床试验机构成功备案！
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isolate;box-sizing: border-box;" powered-by="xiumi.us"><section style="font-size: 66px;text-align: center;line-height: 0;color: rgb(255, 219, 177);text-shadow: rgb(224, 64, 66) 2px 2px;box-sizing: border-box;"><p style="margin: 0px;padding: 0px;box-sizing: border-box;"><strong style="box-sizing: border-box;">喜</strong></p></section></section></section></section></section><section style="display: inline-block;vertical-align: top;width: auto;align-self: flex-start;flex: 100 100 0%;background-color: rgba(255, 255, 255, 0);padding: 10px 0px;box-sizing: border-box;"><section style="text-align: left;transform: translate3d(-1px, 0px, 0px);-webkit-transform: translate3d(-1px, 0px, 0px);-moz-transform: translate3d(-1px, 0px, 0px);-o-transform: translate3d(-1px, 0px, 0px);box-sizing: border-box;" powered-by="xiumi.us"><section style="display: inline-block;width: 100px;height: 100px;vertical-align: top;overflow: hidden;border-style: solid;border-width: 1px;border-color: rgb(255, 219, 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rotateZ(90deg);-moz-transform: rotateZ(90deg);-o-transform: rotateZ(90deg);box-sizing: border-box;" powered-by="xiumi.us"><section style="margin: -1px 0% 0px;box-sizing: border-box;"><section style="border-top: 1px dashed rgb(255, 219, 177);box-sizing: border-box;"><svg viewbox="0 0 1 1" style="float:left;line-height:0;width:0;vertical-align:top;"></svg></section></section></section><section style="transform: rotateZ(135deg);-webkit-transform: rotateZ(135deg);-moz-transform: rotateZ(135deg);-o-transform: rotateZ(135deg);box-sizing: border-box;" powered-by="xiumi.us"><section style="margin: -1px 0% 0px;transform: translate3d(-50px, 0px, 0px);-webkit-transform: translate3d(-50px, 0px, 0px);-moz-transform: translate3d(-50px, 0px, 0px);-o-transform: translate3d(-50px, 0px, 0px);box-sizing: border-box;"><section style="border-top: 1px dashed rgb(255, 219, 177);box-sizing: border-box;"><svg viewbox="0 0 1 1" style="float:left;line-height:0;width:0;vertical-align:top;"></svg></section></section></section><section style="transform: rotateZ(45deg);-webkit-transform: rotateZ(45deg);-moz-transform: rotateZ(45deg);-o-transform: rotateZ(45deg);box-sizing: border-box;" powered-by="xiumi.us"><section style="margin: -1px 0% 0px;transform: translate3d(50px, 0px, 0px);-webkit-transform: translate3d(50px, 0px, 0px);-moz-transform: translate3d(50px, 0px, 0px);-o-transform: translate3d(50px, 0px, 0px);box-sizing: border-box;"><section style="border-top: 1px dashed rgb(255, 219, 177);box-sizing: border-box;"><svg viewbox="0 0 1 1" style="float:left;line-height:0;width:0;vertical-align:top;"></svg></section></section></section><section style="transform: rotateZ(135deg);-webkit-transform: rotateZ(135deg);-moz-transform: rotateZ(135deg);-o-transform: rotateZ(135deg);box-sizing: border-box;" powered-by="xiumi.us"><section style="margin: -1px 0% 0px;transform: translate3d(50px, 0px, 0px);-webkit-transform: translate3d(50px, 0px, 0px);-moz-transform: translate3d(50px, 0px, 0px);-o-transform: translate3d(50px, 0px, 0px);box-sizing: border-box;"><section style="border-top: 1px dashed rgb(255, 219, 177);box-sizing: border-box;"><svg viewbox="0 0 1 1" style="float:left;line-height:0;width:0;vertical-align:top;"></svg></section></section></section><section style="isolation: isolate;box-sizing: border-box;" powered-by="xiumi.us"><section style="font-size: 66px;text-align: center;line-height: 0;color: rgb(255, 219, 177);text-shadow: rgb(224, 64, 66) 2px 2px;box-sizing: border-box;"><p style="margin: 0px;padding: 0px;box-sizing: border-box;"><strong style="box-sizing: border-box;">讯</strong></p></section></section></section></section></section></section></section></section></section></section><section style="text-align: center;justify-content: center;display: flex;flex-flow: row nowrap;box-sizing: border-box;" powered-by="xiumi.us"><section style="display: inline-block;width: 90%;vertical-align: top;align-self: flex-start;flex: 0 0 auto;height: auto;background-color: rgb(255, 255, 255);margin: 0px;padding: 15px 0px 0px;border-left: 2px solid rgb(239, 238, 239);border-right: 2px solid rgb(239, 238, 239);border-top: 2px solid rgb(239, 238, 239);box-sizing: border-box;"><section style="text-align: justify;font-size: 16px;color: rgb(0, 0, 0);letter-spacing: 1.8px;padding: 0px 10px;box-sizing: border-box;" powered-by="xiumi.us"><p style="white-space: normal;margin: 0px;padding: 0px;box-sizing: border-box;">近日，从国家药品监督管理局药物临床试验机构备案管理信息平台获悉，我院顺利通过药物临床试验机构备案，备案号“药临床机构备字2023000100”，就是说，现在就可以在备案专业内开展药物临床试验项目啦~</p></section><section style="text-align: justify;box-sizing: border-box;" powered-by="xiumi.us"><p style="white-space: normal;margin: 0px;padding: 0px;box-sizing: border-box;"><br style="box-sizing: border-box;"/></p></section><section style="margin-top: 10px;margin-bottom: 10px;line-height: 0;box-sizing: border-box;" powered-by="xiumi.us"><section style="max-width: 100%;vertical-align: middle;display: inline-block;line-height: 0;box-sizing: border-box;"></section></section><section style="margin-top: 10px;margin-bottom: 10px;line-height: 0;box-sizing: border-box;" powered-by="xiumi.us"><section style="max-width: 100%;vertical-align: middle;display: inline-block;line-height: 0;box-sizing: border-box;"></section></section><section style="text-align: justify;box-sizing: border-box;" powered-by="xiumi.us"><p style="white-space: normal;margin: 0px;padding: 0px;box-sizing: border-box;"><br style="box-sizing: border-box;"/></p></section><section style="text-align: justify;font-size: 16px;color: rgb(0, 0, 0);letter-spacing: 1.8px;padding: 0px 10px;box-sizing: border-box;" powered-by="xiumi.us"><p style="white-space: normal;margin: 0px;padding: 0px;box-sizing: border-box;">自启动GCP筹建工作以来，院领导高度重视GCP建设工作，严格按照《药物临床试验质量管理规范》、《药物临床试验机构管理规定》等法规、规范要求完善组织架构，完善硬件设施设备，优化建设用房布局，制定GCP管理制度，标准操作规程（SOP），开展线上线下人员及文件体系培训等，为后期确保临床试验的质量奠定了坚实的基础。<br style="box-sizing: border-box;"/></p></section><section style="margin-top: 10px;margin-bottom: 10px;line-height: 0;box-sizing: border-box;" powered-by="xiumi.us"><section style="max-width: 100%;vertical-align: middle;display: inline-block;line-height: 0;width: 50%;height: auto;box-sizing: border-box;"></section></section><section style="text-align: justify;font-size: 16px;color: rgb(0, 0, 0);letter-spacing: 1.8px;padding: 0px 10px;box-sizing: border-box;" powered-by="xiumi.us"><p style="white-space: normal;margin: 0px;padding: 0px;box-sizing: border-box;"><span style="letter-spacing: 1.8px;box-sizing: border-box;">2023年7月27日至28日，江苏省药品监督管理局审核查验中心组织专家检查组，对我院的药物临床试验机构、医学伦理委员会以及专业进行了现场监督检查。专家检查组通过听取汇报、现场检查、查阅资料、考核提问等形式，对机构、医学伦理委员会及专业科室的组织架构、设施设备、文件体系等情况进行综合评定。经过为期2天严谨认真的评审后，专家检查组对我院在药物临床试验机构备案方面的工作给予了充分肯定和鼓励。同时，专家检查组也对机构、医学伦理委员会以及专业领域中存在的问题，提出了宝贵的建议和改进意见。</span><br style="box-sizing: border-box;"/></p></section><section style="margin-top: 10px;margin-bottom: 10px;line-height: 0;box-sizing: border-box;" powered-by="xiumi.us"><section style="max-width: 100%;vertical-align: middle;display: inline-block;line-height: 0;box-sizing: border-box;"></section></section><section style="text-align: justify;font-size: 16px;color: rgb(0, 0, 0);letter-spacing: 1.8px;padding: 0px 10px;box-sizing: border-box;" powered-by="xiumi.us"><p style="white-space: normal;margin: 0px;padding: 0px;box-sizing: border-box;"><span style="letter-spacing: 1.8px;box-sizing: border-box;">此次我院药物临床试验机构成功备案，对我院科学研究、学术水平和医疗质量水平的提高具有重要意义，同时为受试者参加新药临床试验提供了安全保障，也是医院综合实力提升的体现。未来，我院药物临床试验机构将继续严格遵守《药物临床试验质量管理规范》及相关法律法规，按照标准操作规程开展临床试验，保护受试者的权益和安全，确保临床试验的科学性、真实性及规范性。加强与同行之间的交流合作，不断提高临床试验机构的研究实力，更好的造福广大患者。</span><br style="box-sizing: border-box;"/></p></section><section style="text-align: justify;box-sizing: border-box;" powered-by="xiumi.us"><p style="white-space: normal;margin: 0px;padding: 0px;box-sizing: border-box;"><br style="box-sizing: border-box;"/></p></section><section style="text-align: left;justify-content: 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医疗水平又上一个档次 赞！
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