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Ethics, quality and oversight in the clinical development of medical devices

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

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.

On 15 June 2015, the day of the Conference, participants will have the chance to debate on the new regulations under consideration in the EU.

Based on the impact assessment from the first day, participants attending the Workshop on 16 June 2015 will be able to work concretely on current issues and give their recommendations for the future EU regulatory framework for medical devices

download the programme

Should you have any question, please feel free to contact AIM International Group on the name of EFGCP - Grensstraat, 7 - B-1831 Diegem, Belgium

tel.: +32 2 722 82 30 - Fax +32 2 722 82 40

E-mail: efgcp2015.reg@aimgroup.eu