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根据我国新修订的《药品管理法》，药品上市许可持有人对药品研制、生产、经营、使用全过程中的药品的安全性、有效性和质量可控性承担全面的责任。基于药物警戒活动对患者安全和对公众健康的重要性，药品监管部门需要定期或不定期地组织药物警戒检查，以确定上市许可持有人药物警戒职责履职合规的情况，帮助持有人提升药物警戒工作水平和能力。 ...

Share updates on IMP shipping, raw data analysis, Patient-Focused Drug Development, RRA, RWD/RWE, CSA. ...

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. ...