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2018 Abstracts to the Programme

Title: Practical application of the EMA 0070 Policy on publication of clinical data for medicinal product for human use

Presenter: St├ęphane Chollet

Presentation Slides: Click here to access

Organisation: Keyrus Biopharma


The EMA Policy 0070 requires the applicants/MAHs to publish their clinical reports as well as the individual subject data. In parallel, the European Global Data Protection Regulation, which will come into force by May 2018 and applies to all data processing, requires that personal data be protected. This presents a challenge: how do you protect the privacy of personal data that are being released to the public domain while keeping the scientific interest?

External guidance on the Policy 0070 implementation has been released on April 2017. This guidance proposes a process to implement for the clinical data disclosure while ensuring the personal data protection. In the current presentation we will evaluate the proposed process using cases for the illustration and providing additional topics for reflection. We will go through the following topics:
– General consideration about data anonymization (applicable techniques for clinical data),
– Management of the re-identification risk (identifiers detection, risk computation, threshold),
– Additional concerns for the risk minimization (how to screen the data base for outliers and ensure that all the information have been managed).

Learning Objective 1: Good understanding about GDPR and EMA Policy 0070 for the clinical data

Learning Objective 2: Performing the re-identification risk assessment and threshold determination

Learning Objective 3: Implementing a de-identification strategy


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