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22 May 2019

Optimising the generation and regulatory application of clinical evidence in the European Union and the United States

Chairpersons: R. Byrne, M. W. Kayo
Panellists: M. C. Morice, R. Waksman
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Summary

Consult this session to discover innovative approaches for collecting and utilising clinical evidence, and learn more about how to conduct efficient clinical research to support marketing approval in the European Union, the United States, or regions dependent on the CE mark or FDA approval.

Learning Objectives

  • To understand innovative approaches for collecting and utilising clinical evidence
  • To appraise changes in global pre-market and post-market regulatory processes
  • To conduct efficient clinical research to support marketing approval in the European Union, the United States, or regions dependent on the CE mark or FDA approval

Presentations available when logged in:

  • Introduction
  • What novel approaches has the FDA taken to stimulate clinical research and approval of new medical devices?
  • Efficient collection and use of post-market data in the United States
  • The landscape for clinical evaluation of medical devices in the European Union: what to expect under the Medical Device Regulations
  • Existing European databases – The contributions of SWEDEHEART / SCAAR
  • The QMUL-Barts-Yale collaboration: an example of transatlantic harmonisation and convergence