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临床试验数据的匿名化与删减处理的对比分析
Anonymization vs. Redaction of Clinical Trial DataBlog

临床试验数据的匿名化与删减处理的对比分析

2025 年 1 月 17 日 The vernacular for disclosing pharmaceutical clinical trial results to the public may seem just as confusing as the process! Some people…
制定 EMA 政策0070 提交材料的常见问题解答
FAQs on Developing EMA Policy 0070 SubmissionsBlog

制定 EMA 政策0070 提交材料的常见问题解答

In September 2023, the European Medicines Agency (EMA) reinstated its Policy 0070 requirement to publish all clinical studies submitted for…
How To Respond to Health Authority Questions
How To Respond to Health Authority Questions Blog

How To Respond to Health Authority Questions

Your biotech company has just submitted the marketing application for your first drug product. It’s a moment of celebration after…
为什么需要药物综合发展计划?
Why You Need an Integrated Development PlanBlog

为什么需要药物综合发展计划?

Learn about the Integrated Development Plan for successful drug development & its relation to the Target Product Profile & Clinical…

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