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2023年中国药监局NMPA蓝皮书已发布:

The New Landscape of China Clinical Evaluation (Part III): How to Prepare for Clinical Trial Audit

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  • 创建日期 30 4 月, 2024
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The New Landscape of China Clinical Evaluation (Part III): How to Prepare for Clinical Trial Audit

Auditing is one of the important procedures in the clinical trial quality management system. It is a systematic and independent audit of clinical trial-related activities and documents to evaluate and determine whether the implementation of clinical trial-related activities, the recording, analysis and reporting of trial data comply with protocol, standard operating procedures and relevant laws and regulations.
Join our exclusive webinar as we delve into the intricacies of China NMPA clinical trial onsite audits. Led by seasoned industry experts, this webinar will provide invaluable insights into the entire audit process, from preparation to execution and post-audit follow-up.
* Overview of China NMPA regulations: understand the regulatory framework governing clinical trials in China and the role of NMPA in ensuring compliance
* Preparing for onsite audits: learn best practices for preparing your organization, facilities, and personnel for NMPA audits
* Navigating the audit process: gain a step-by-step understanding of what to expect during an onsite audit, including key areas of focus, common pitfalls, and strategies for success
* Case study and key takeaways

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