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Navigating Safely Through the Regulatory Triangle: Clinical Trials – In vitro Diagnostics – Data Protection

September 7, 2016

A conference organized by the EORTC

The cancer clinical research landscape is changing, and trials are already becoming more targeted to take advantage of a constantly expanding understanding of cancer biology complemented by new technologies such as next generation sequencing and BIG data. Clinical researchers are facing a sea of change, both scientifically as well as regulatory.

As far as regulations are concerned, Europe’s clinical research ship is still under construction. Among other things, the Clinical Trial Regulation is expected to be applicable in 2016, and the In vitro Diagnostics and Data Protection Regulations have been drafted and are currently being discussed by the EU parliament and Council.

However, all three of these regulations were worked out in silo, scant attention was given to how these three might work together, and impending changes in the clinical trial landscape were not fully appreciated.

This conference will explore the interface between these three regulations, and how these will influence the cancer research practice in the near future.

Website: http://www.eortc.org/regulatory/


September 7, 2016


Square Brussels Meeting Centre
Brussels, Belgium
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