CQAF 2017 Annual Meeting Newsletter

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.

2017年5月25日, China Quality Assurance Forum (简称CQAF) 年度会议如期在罗 氏制药上海会议室召开。来自40家包括制药企业、临床试验机构、CRO等78名论 坛会员共同参与。

本年会重点探讨了电子原始数据（政府检查视角），申办方自查战略和实施（针对 CFDA 2015年第117号公告等),以及 CQAF项目更新和年度奖项。

Inspection Perspective in Electronic Source Data

Dr. Alexander Hönel from QBEX(Quality by Experts) firstly provided an overview of Source data inspection, including interpretation of basic definition of source data, source data requirement, source data review and inspection goals and constraints, then the risk assessment and key risk factors were discussed, including the common systems, system relevant processes, system/data dependency, different risks and issues by studies of various phases, extreme example of inspection outcome, common inspection findings in electronic source data, and relevant reference etc.

During the meeting, the following topics were warmly discussed among members, 

♦ New requirements in ICH E6 R2 regarding case report form and its implementation...........

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