Under EMA Policy 70 Publication of Clinical Data, clinical overviews and study reports submitted as part of a Marketing Authorisation Application are published and made publically available. Before documents are published, sponsors need to anonymise the documents aligned to data privacy requirements.
The intent of this webinar is to describe what is involved in anonymising clinical data, and present the different methods and approaches available for anonymisation including an introduction to residual risk assessment. Examples from the PhUSE Data De-Identification Standard will also be discussed.
Jean-Marc Ferran (Qualiance / PhUSE) will present ‘Anonymising Clinical Data – key principles, methods and considerations’. Chrissie Fletcher will facilitate a Q&A session.
For details please contact Chrissie Fletcher fletcher@amgen.com
Registration is now closed.
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