Interactive Multi-Stakeholder Workshop of the Joint EFGCP-MedTech Europe Medical Technology Working Party on Methodology of Clinical Investigations across Medical Devices Lifecycle
All medical devices need clinical evidence in order to be lawfully and successfully marketed. Identifying the best methodology for building this evidence, however, depends on several factors, including the device’s intended purpose and patient population, the stage it is at within its lifecycle, and its underlying technology.
Starting from the premise that “the clinical objective drives the clinical evidence need,” this workshop explores the different clinical methodologies applied to medical devices as compared to medicines, both before and after the device is first marketed.
Participants will learn about and debate the central role of physicians/users in clinical studies, the merits and limitations of open label trials, comparative trials and randomized controlled trials (RCTs), and the best practices in how to leverage the power of registries and ‘Big Data.’ Presenters will include key stakeholders including regulators, Notified Bodies, reimbursement experts, patient organization representatives and industry members.
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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