Best Practices for Complying with EMA Policy 70

Lora Killian

EMA Policy 70 requires sponsors to publish anonymized versions of clinical study reports (CSRs) and submission documents submitted in support of a marketing authorization application (MAA) after January 1, 2015. Sponsors must prevent re-identification of people named or referred to in those documents. In March 2016, the detailed guidance document was published. This blog post […]

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Topics: Regulatory Writing
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