Navigating Safely through the Regulatory Triangle: Clinical Trials – In vitro Diagnostics – Data Protection
September 07, 2016 - September 07, 2016 | Square - Brussels Meeting Centre
Legislative frameworks have been developed in silos, and the needs of clinical research and even its very nature is poorly understood. Legislations focus on either healthcare or commercialization of a product and not on the required research. In the last two years the EU has drafted several major regulations touching on clinical trials, in vitro diagnostics, medical devices and data protection, all of which will impact clinical research, yet the silo approach makes the overall framework inconsistent and potentially damaging to EU capacity to make rapid progress in the field of precision medicines.
This conference will explore the interface between the Clinical Trial Regulation, expected to be applicable in 2017-2018, and the In vitro Diagnostics and Data Protection regulations now being discussed by the EU Parliament and Council.