| FREE WHITEPAPER
Preparing for EMA's Clinical Data Publication Policy
What sponsors need in place before Policy 0070 redaction review begins.
EMA’s Policy 0070 requires sponsors to submit anonymised, redacted versions of clinical reports for public disclosure, and the review window is shorter than most teams expect. This whitepaper walks through where sponsors typically lose time, and how to structure document planning so redaction doesn’t become a bottleneck at submission.
This whitepaper will cover:
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What Policy 0070 requires, and which submissions are in scope
What Policy 0070 requires, and which submissions are in scope
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Building an anonymisation report sponsors can defend
Building an anonymisation report sponsors can defend
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Common redaction pitfalls that trigger EMA queries
Common redaction pitfalls that trigger EMA queries
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Aligning medical writing and regulatory timelines early
Aligning medical writing and regulatory timelines early
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A pre-submission checklist for redaction readiness
A pre-submission checklist for redaction readiness