ABHI Regulatory Conference 2020

25 November 2020
10:30 AM - 15:00 PM

From 1st January 2021, manufacturers wishing to place devices on the Great Britain market are able to use a new route: the UK Conformity Assessment (UKCA) mark. With a two and a half year phasing-in period, the UKCA mark will be mandatory from June 2023, and will become the only way to access the market thereafter. How then, will the UKCA mark interact with the European CE Mark, as well as other jurisdictions, and will the system be ready to fully implement this by 2023?

With regulation in the spotlight like never before, this year’s flagship ABHI conference promises to be the HealthTech industry’s must-attend event. Split into two parts, the morning session will focus on regulatory strategy, the shift towards global harmonisation and how, post-Brexit, regulation can contribute to the attractiveness of the UK as a place to develop and distribute health technologies. The afternoon session will address the practical elements of the UKCA mark, how this route will interact with Europe, and the actions companies need to undertake to ensure compliance

As we delve into the regulations for devices, diagnostics and digital, delegates will hear from regulators, notified bodies, industry and legal professionals, who will all give their expert opinions and share the benefit of their close involvement in all matters regulatory.

Speakers include:

  • Dr Samantha Atkinson, Chief Quality and Access Officer, MHRA
  • Oliver Bisazza, Director Regulations & Industrial Policy, MedTech Europe
  • Phil Brown, Director, Technical & Regulatory, ABHI
  • Samantha Cooper, Director of Professional Development, TOPRA
  • Camilla Fleetcroft, Interim Group Manager - Devices Regulatory Group, MHRA
  • Prof Alan Fraser, Chairman, Regulatory Affairs and Medical Devices Task Force, Biomedical Alliance in Europe
  • Janine Jamieson, European Editor at International Pharmaceutical Quality
  • Dr David Jefferys, Senior Vice President for Global Regulatory, Healthcare Policy, Corporate Affairs and Patient Safety, Eisai Europe 
  • Jayanth Katta, Senior Regulatory Lead BSI
  • Phil Kennedy, Managing Director, Eschmann Technologies
  • Dr Michael Kipping, Innovation Lead - Biomedical Catalyst, Innovate UK
  • Steve Lee, Director, Diagnostics Regulation, ABHI
  • Shuna Mason, Partner, CMS
  • Gary Slack, Senior Vice President - Global Medical Devices, BSI
  • Antoine Valterio, Country Manager, UK/Ireland , ResMed

For more information, and to register, click here.

View the agenda here.