Navigating Safely Through the Regulatory Triangle

Date

07 Sep 2016

Address

Square Brussels Meeting Centre
Rue Ravenstein, 2
1000  Brussels
Belgium

Event Type

L - Conference, forum

Section

Health & Consumers
Innovation & Enterprise

Event Location

Brussels

Event Description

Cancer clinical trials and, in general, cancer clinical research are, by definition, multi-modal disciplines. It is not enough to discover and register new drugs.  Getting cancer under control, or even better, curing it, requires researchers to perform complex clinical studies that integrate drugs, companion diagnostics, new or improved surgical procedures, and new approaches to radiotherapy.

Moving towards precision medicine is one of today’s important objectives in the EU as can be witnessed on the DG Research and Innovation website:

“Today, many medicines do not work effectively for a large number of the patients they are supposed to treat. Personalized medicine aims to improve this situation by providing the right diagnosis leading to prevention or to treatment at the right dose to the right patient at the right time.” “Personalized medicine depends on the use of relevant biomarkers and the development of appropriate diagnostic methods, both in vivo and in vitro, for the stratification of patients into groups.”

Research is indeed becoming more targeted. It incorporates technologies that exploit ever increasing amounts of data using Big Data technologies. It aims to integrate all available information and includes data resulting from analysis of biological material and, more and more, genetic data. The general approach is holistic in a drive towards maximizing performance and minimizing costs and time.

Europe’s clinical research regulatory ship is being outfitted to face this storm.

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 2016-2017, and the In vitro Diagnostics and Data Protection regulations now being discussed by the EU Parliament and Council.

It will conclude with a pragmatic but creative brainstorming session on how might rapidly fix issues identified within the limits of the new or soon to become legal framework.

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