Pro Te: Solutio - Vol.9 No.3 – Fall 2016

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The Fall 2016 issue of Pro Te is about all things regulatory, including a peek at the newly developing issue of crowdfunding for medical devices.

In EMA Guidance on Clinical Data Publication, we discuss recent guidance from the European Medicines Agency regarding publication of data from clinical trials. In particular, this article addresses how to achieve the goals of sharing clinical trial data to avoid duplication of effort, build public trust and assist researchers while also meeting the standards for privacy that are central to any clinical trial.

Please see full publication below for more information.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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