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Public Access to Clinical Data: The evolution of initiatives from the European Medicines Agency

Post thumbnail Public Access to Clinical Data: The evolution of initiatives from the European Medicines Agency

It remains the mission of all stakeholders to get high quality medicines to patients as time- and cost-efficiently as possible. To facilitate this process, the EMA has taken a number of initiatives to make clinical data, submitted to support marketing authorisations, increasingly available to industry and the general public alike.

However, it is important that the data made public is presented in such a way that it is not possible to identify specific individuals who participated in a clinical study and to ensure that their personal data is appropriately protected, in line with current legislation.

In this paper, you will see the latest data transparency updates for Policy 70 and the timelines for Clinical Reports.

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    whitepaper by

    Chris Wilson
    Chris Wilson, M.Sc., MTOPRA
    Senior Director, Drugs & Biologics
    As Senior Director Regulatory Science, Drugs, and Biologics Chris provides leadership and support across Market Access, Regulatory, and Medical / Regulatory Writing functions.   In…
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