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Event: Joint EFGCP-MedTech Europe conference, London, June 2015

Event: An Interactive Multi-Stakeholder Conference and Workshop of the Joint EFGCP-MedTech Europe Medical Technology Working Party on Ethics, Quality and Oversight in the Clinical Development of Medical Devices

Date: 15 & 16 June 2015

Location: University College London, London, United Kingdom

Clinical development of medical devices is a continual process spanning the full product lifecycle. Designing, executing, and ensuring oversight of clinical studies across this lifecycle, while meeting the highest standards of quality and ethics, is a special challenge for medical devices as it is for medicines.

The ongoing revision of the EU regulatory framework for medical devices seeks to establish new clinical evidence standards, aligning the rules - where useful and applicable to medical technology - with the new Clinical Trials Regulation for Medicinal Products. Greater harmonisation is also expected in terms of how Member States enforce these rules, such as through inspections and ethics committee overview.

This Joint EFGCP-MedTech Europe conference will explore existing best practices and forthcoming changes in the clinical development of medical devices. Through dialogue between regulators, patients, healthcare professionals, CROs and industry, the event will provide early insight into the future clinical evidence rules for medical devices, while offering regulators insight into the practical challenges facing their stakeholders.

 

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