The Future of In-Vitro Diagnostics: A Regulatory Perspective

How can regulators strike a reasonable balance between supporting diagnostic innovation and providing rigorous independent evaluation of new diagnostic tests before they enter clinical practice? How can regulators strike a reasonable balance between supporting diagnostic innovation and proving rigorous independent evaluation of new diagnostic tests before they enter clinical practice?

In this workshop, we will hear from Alberto Gutierrez (former Director of FDA's Office of In Vitro Diagnostic Device Evaluation and Safety), Robyn Meurant (World Health Organisation) and Stuart Hogarth (University of Cambridge) and consider regulatory developments in the context of the US response to the genomic revolution in biomedicine as well as the need for safe and effective diagnostics in low and middle-income countries.

This workshop is aimed at all those involved in development of new diagnostic tests in academia and industry. Attendance is free, and for more information and to register please visit the link below.