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“DIA中国GCP现场核查 - 从自查到核查的管理研讨班”于11月6-7日在北京举行。由中国质量保证论坛(CQAF)的多位专家结合多年的国内外QA 领域工作经验,亲自设计课程、 讲解与带队练习,并邀请海外及药监领域专家现身说法。 ...
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In Sept. 11th , 2017, China Quality Assurance Forum (referred to as CQAF) 2017Q3 Meeting was held in Astellas Shanghai and Beijing meeting room. Total 56 members from 53 organizations participated in this conference. This Quarterly meeting focused on the topics around eConsent, ePRO, and as well as updates of CQAF Projects and CQAF membership registration. ...
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In May 25th , 2017, China Quality Assurance Forum (referred to as CQAF) Annual Meeting was held in Roche Shanghai meeting room. Total 78 members from 40 organizations, including pharmaceutical companies, clinical trial institutions and CROs participated in this conference. This Annual Conference focused on the topics around Inspection Perspective in Electronic Source Data, Self-Assessment Strategy and Approach for CFDA PreApproval Inspection Readiness, and CQAF Projects Updates & Awards. ...
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During the recent China QA Forum Face-to-Face meeng on 25 May, a workshop was organized to discuss how to manage self-inspecon in China in reflecon of CFDA self-inspecon requirements issued on 22 Jul 2015. Below is the summary of the discussion: Note: Self-inspecon in this arcle refers to sponsor’s acvies to idenfy and report issues occurred in the study to CFDA via subming the self-inspecon report for studies that have been submied to CFDA but pending for the agency’s approval. ...