The Q3 meeting for CQAF members was held virtually in the afternoon of 27 Sep 2022. Speakers from Bayer and Roche pharma companies presented two topics of “Together with Patients” and “Patient Centricity Clinical Study of Rare Diseases”, walked the audience through the practice of the patient group engagement across the clinical trials and the relevant opportunities and challenges, such as patient recruitment, retention, education etc.. Then the founder of Chinese Organization for Rare Disorders (CORD) brought the topic “Leverage Patient Org to Promote the Drug R&D” and shared the insights from rare disease patient perspective. The two-hour meeting was closed in a panel discussion joined by CQAF core team members. ...

上期(基于风险的药物警戒审计 - I)，我们介绍了药物警戒审计的类型及目的，基于风险的药物警戒审计计划和常见的药物警戒检查发现等话题。本期，将从流程的角度，分享如何开展一个常规的药物警戒审计，以及审计流程中各个部分的基本考量。 ...

Share updates on GCP Inspection, RWE/RWD, KPI, Q&A Guidance on Complex Clinical Trials. ...

The Q2 meeting for CQAF members was held virtually in the afternoon of 22 June 2022. Speakers from Huashan Hospital and MNC pharma companies presented two topics of “How we interpret the test reports under the mutual recognition of test results” and “the Clinical Laboratory Audit” respectively. ...

在CQAF核心团队的大力支持下，《初创公司临床研发培训管理的要素与考量》的专题课程新鲜出炉！同时感谢DIA中国质量社区“Q站点”活动中所有参与者关于“建立和优化培训管理体系”的讨论，以及多位初创公司的质量管理者就培训管理相关的分享与反馈！ ...

药物警戒审计（亦称 “内部审核”、“内审”、“稽查”）是质量管理的重要一环，是评估药物警戒体系及其质量体系的适宜性、充分性、有效性的重要方式1。审计人员独立于药物警戒部门之外，能更客观、系统、全面地审查药物警戒相关制度、规程及其执行情况。审计不仅可以发现质量问题，促进持续改进；同时也可以验证现有体系的适宜性、充分性和有效性，以保障全面符合相关法律法规的要求。 ...