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Opportunities around global regulatory convergence

December 2, 2021 @ 9:30 am - 10:30 am

More importantly, the industry has delivered in an open, innovative, agile, patient focussed and safe manner. Our sector believes that without the willingness of the industry to work globally and to stay focused on what patients and hospitals needed most, this incredible response would not have happened. The global regulatory agencies also responded positively but it must be also said, however, that the pandemic exposed some of the weaknesses of the various global regulatory agencies. It laid bare the fact that the various regulators aren’t as well aligned globally as they probably should be. The pandemic highlighted the need for more agility, speed, change management and urgency—while never compromising on safety—in our global regulatory agencies. All of this came at a time when the regulators and Industry had to manage the implementation of the Medical Device Regulations. Lessons can and should also be learnt from this ongoing experience. This session will explore this topic and hear the views from our expert panel on how we can collectively respond to the issues and challenges raised during the COVID-19 pandemic and the ongoing EU implementation of the Medical Device and IVD Regulation.

Chair: Emmett Devereux, Director Government and Regulatory Affairs, Cook Medical

Speakers:

  • Elizabeth Devereux, Associate Director for Scientific & Regulatory Programs, Center for devices and Radiological Health, FDA
  • Philippe Auclair, Senior Director, Regulatory Strategy, Abbott
  • John O’Dea, CEO, Palliare

Details

Date:
December 2, 2021
Time:
9:30 am - 10:30 am
Event Category:

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