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Establishing best practices in clinical development of in vitro diagnostics, companion diagnostics and healthcare apps: barriers and pathways to success

This interactive multi-Stakeholder workshop is organised by EFGCP & MedTech Europe in partnership with EDMA, Chamber of Commerce & Industry of Serbia and KLINIS. New regulations under consideration in the EU focus on new technologies such as novel in vitro diagnostics, companion diagnostics and on the development of healthcare apps, all of which rely on information to deliver positive health outcomes. Gathering clinical evidence and knowing when and how to conduct clinical investigations for these new technologies is a challenge which still needs to be addressed.

This Joint EFGCP-MedTech Europe Working Party workshop will focus on the means to address these open questions and on the generation of clinical evidence for IVDs, companion diagnostics and healthcare apps, from the point of view of clinicians, patients, regulators and product developers.