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.