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. ...

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. ...