Anonymization for EMA Policy 0070

Big Challenges and Solutions for Anonymizing Clinical Trial Data

Under the EMA Policy 0070, manufacturers are required to submit anonymized versions of clinical reports to the agency, as well as a risk analysis report documenting how the risk of re-identification is considered sufficiently small. These documents will then be made publicly available under two different data sharing mechanisms. Many manufacturers are now trying to figure out how to meet these requirements for their new submissions.

In Anonymization for EMA Policy 0070, featuring Dr. Khaled El Emam, we will describe methods for the anonymization of clinical reports, and methods for measuring the risk of re-identification for such documents, with examples comparing anonymization techniques with redaction techniques.

CSR anonymization beyond pure redaction is possible – learn from the experts how to balance utility, privacy and compliance.

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