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.
PSI, the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) and the Biopharmaceutical Section of the American Statistical Association (ASA) are jointly organising a webinar on Estimands in Practice. Speakers from regulatory authorities (FDA and EMA) and industry will present on their experience on this topic to date.
Discover your potential by working as a Covance Senior Principal / Principal Biostatistician. You'll enjoy a varied role working for different sponsors across several therapeutic areas, leading projects and mentoring junior members of the department.
Biometrics at AstraZeneca provides the data that influences decisions on how we roll back the frontiers of science to bring life-changing medicines to the world. We are at the heart of design, analytics and interpretation of AstraZeneca’s portfolio.