15 November 2024
Conference: How to open up clinical and research data The interplay between rules, standards and practices, Start time 9:00 am Palazzo di Giurisprudenza – Via Verdi 53, Trento, Room 5
“Clinical and research activities produce enormous amounts of data. These data represent an invaluable treasure from multiple points of views: scientific interests in creating new medicines and pursuing progress and innovation in the health domain, the necessity to verify the studies carried out, the purely commercial approach on protecting the effort to obtain a marketing authorization (i.e drug control regulation by reference agencies), and the public interest in access and disclosure. Access to this information is often severely limited (if not completely hindered) by forms of exclusive rights (Intellectual Property Rights, Sui generis protection such as the so-called data exclusivity, etc.). The regulations regarding the protection of personal data (indirectly) contribute too in making sharing processes more complex. On the contrary, Open Science, FAIR (Findability, Accessibility, Interoperability, and Reuse) principles, transparency and flexibility needs and the creation of public databases on clinical trials and health data push forward the implementation of accessible or open data.
The Conference aims to investigate the interplay between the several legal tools involved in this phenomenon and open science for health and clinical trial data from multiple perspectives, focusing on EU law but with a comparative approach and methodology (i.e. USA, Canada, Israel, South-Africa) that takes into account the complex regulatory framework”
