HealthXL Member Webinar with ICON: Regulation Landscape for Medical Devices in Digital Health

This webinar will feature one of the HealthXL Members - ICON, a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries.

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Additional Information

ICON have experience and knowledge to support customers throughout the entire product lifecycle, from defining the regulatory development strategy, to clinical trial and marketing authorisation submissions, through to post-licensing support. They also offer a range of strategic and operational services, including clinical investigation submissions and CE-marking expertise.

The goal of the webinar is to:

  • provide the HealthXL Community with an overview of the regulation landscape for medical devices in digital health
  • highlight the key differences between the regulation landscape for medical devices in digital health in the the US and the European Union

Agenda

  • 5:00pm GMT: Introduction to ICON by Dr Brendan Buckley
  • 5:10pm GMT: Overview of the regulation landscape for digital health by Dr Dairine Dempsey
  • 5:35pm GMT: Q&A with Dr Brendan Buckley, Dr Dairine Dempsey, Anand Iyer

Presenters:

Dr Brendan Buckley, Chief Medical Officer of ICON and an endocrinologist with over 30 years’ experience. Brendan represents ICON's position on key scientific, ethical and medical governance matters and provides guidance and oversight to the medical and scientific groups across ICON. Brendan has been a board member of the European Medical Agency (EMA)’s Scientific Advisory Group for Diabetes and Endocrinology since 2005.

Dr Dairine Dempsey, Vice President of Strategic Regulatory Affairs at ICON, is a PhD pharmacist with over 15 years' experience as a pharmaceutical regulator. Dairine has held a number of senior positions in the Irish national competent authority for medicines, where she represented Ireland at the European Medicines Agency, the European Commission & internationally. She has also provided consultancy services to the pharmaceutical industry and governmental agencies in the EU, USA and globally.

Anand Iyer, Chief Strategy Officer of WellDoc. Anand has played an important role with the International Medical Device Regulators Forum (IMDRF), in the creation of a global guidance document to address the unique needs of Software as a Medical Device.