Location: Online

Times: 1pm to 5pm UK time

Agenda:

Tuesday 3 November 2020

• 13.00 – 13.05 Welcome & Notices – Chairman – David Bell, Director of Standards Policy, British Standards Institution (BSI)
• 13.05 – 13.50 Opening Keynote Address “COVID, Cumberlege and the future of medical device regulation in the UK” – Graeme Tunbridge, Director Devices, Medicines & Healthcare Products Regulatory Agency (MHRA)
• 13.50 – 15.05 European Union (EU) Medical Device Regulation (MDR) implementation – Lessons learned. Experience from across the system – Eamonn Hoxey (Moderator), Director, EV Hoxey Ltd, Suzanne Halliday, Regulatory Director, Head of Medical Devices BSI Notified Body, Helen Forsdyke, Senior Director, Johnson & Johnson, Andy Flockhart, Life Science and Medical Device Director, Deloitte, Paul van Geffen, Senior Manager Regulatory Risk, Deloitte
• 15.05 – 15.30 Break
• 15.30 – 16.25 All things clinical, for Medical Device Regulation (MDR) so what is needed – Richard Holborow, Head of Clinical Compliance, BSI Notified Body
• 16.25 – 16.55 Quality Management System (QMS) – Future concepts, High Level Structure, ISO 9001 Systematic Review, ISO 13485 & US FDA QSR – What next for global quality management systems – short panel discussion – Eamonn Hoxey, Director, EV Hoxey Ltd, Matt Graf, Director, Corporate Quality Systems, Cook Medical, Mark Swanson, President, QRx Partners
• 16.55 – 17.00 Closing remarks – Chairman – David Bell, Director of Standards Policy, British Standards Institution (BSI)

Wednesday 4 November 2020

• 13.00 – 13.10 Welcome & Notices – Chairman, Dr Michael Kipping, Innovation Lead, Innovate UK
• 13.10 – 13.55 Opening Keynote Address ‘Patient Safety and the Role of Safety Investigations’ – Keith Conradi, Chief Investigator Healthcare Safety Investigation Branch (HSIB)
• 13.55 – 14.55 Innovation – COVID 19 – Artificial Intelligence (AI) /Machine Learning (ML) – Rob Turpin, Head of Sector (Healthcare), BSI, Dr Michael Kipping, Innovation Lead, Innovate UK, Joe Lewelling, Vice President, Standards Development, AAMI
• 14.55 – 15.25 Break
• 15.25 – 16.25 European Standards Harmonisation the process and the way forward – Tony Wilkes, Consultant, HAS, Nele Zgavc, International Lead Programme Manager (Healthcare), BSI & Advisory Board for Healthcare Standards (ABHS) Secretary, Richard Bancroft, Science and Technical Director, STERIS
• 16.25 – 16.55 Brief standards update – ISO’s incl. 15223, 20417 – Lena Cordie – Bancroft, President, Qualitas Professional Services
• 16.55 – 17.00 Closing remarks – Chairman, Dr Michael Kipping, Innovation Lead, Innovate UK