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Anonymization vs. Redaction of Clinical Trial Data
Anonymization vs. Redaction of Clinical Trial DataBlog

Anonymization vs. Redaction of Clinical Trial Data

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…
FAQs on Developing EMA Policy 0070 Submissions
FAQs on Developing EMA Policy 0070 SubmissionsBlog

FAQs on Developing EMA Policy 0070 Submissions

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…
統合型開発プランが今、重要な理由とは
Why You Need an Integrated Development PlanBlog

統合型開発プランが今、重要な理由とは

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

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