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BSI/AAMI International Standards & Regulation Conference – 17 -18 October, London

By September 29, 2023No Comments

 

Date: 17 & 18 October 2023

Timing: 08.30 to 19.00 on Day 1/ 08.30 – 16.30 on Day 2

Venue: The Hilton Paddington, London

This two-day in-person and online event will give delegates important updates on a wide range of issues affecting the global medical devices/healthcare market.

With a focus on patient safety, we’re covering most of the sector’s current ‘hot topics’ from AI regulations in Europe and the UK, to an update on the EU MDR transition proposal. Our top speakers include global regulators, clinical professionals, medical device company experts and consultants, plus representatives from notified/approved bodies and national standards bodies.

At the end of Day 1, delegates can join a networking reception.

Participants will gain:

  • the latest information on key topics impacting the medical devices sector
  • expert knowledge and insights including from regulators and notified bodies
  • in-person networking opportunities to establish professional contacts and build relationships
  • a post-event copy of all presentations and a recording for future reference.

The agenda is below:

Agenda

Tuesday 17th October 2023

08.00 – 08.30     Registration/Coffee/Tea                            

08.30 – 08.45     Welcome & Opening remarks

Dr Michael Kipping, Director, Medical Technologies EMEAA, Element

08.45 – 09.30 Global conformity – what next for the UK (title to tbc)     

Graeme Tunbridge, SVP Global Regulatory and Quality, Regulatory Services

09.30 – 10.45     Artificial Intelligence/Machine Learning, AI Regulation, AI Standards – what next?        

Aris Tzavaras, BSI RS Head of AI Notified Body  

10.45 – 11.15 – Networking/Tea/Coffee break

11.15 – 12.00     Update on the EU MDR Transition proposal NB resource

Purvi Patel, BSI RS Regulatory Lead

12.00 – 13.00     UK Medical Device Regulations update 

Purvi Patel, BSI RS Regulatory Lead

13.00 – 14.15 – Networking Lunch

14.15 – 15.15     Clinical data & Clinical Investigations    

Richard Holborow, BSI RS Head of Clinical Compliance

Rachel Mead, BSI RS Clinical Regulatory Lead

Dr Amie Smirthwaite, Senior. VP, Global Intelligence & Innovation, RQM+

15.15 – 15.45 Networking Tea/Coffee break

15.45 – 17.15     FDA updates, Implementing Rule QSR/ISO 13485

17.15 – 17.20     Chair’s concluding remarks

17:30 – 19.00 Networking reception

Wednesday 18th October 2023    

08.00 – 08.30     Registration/Coffee/Tea                              

08.30 – 08.45     Chairman’s welcome & Opening remarks            

Dr Michael Kipping, Director, Medical Technologies EMEAA, Element

08.45 – 09.30 Keynote address, questions & answers

Wendy Rayner, Head of NHS Circular Economy Program, Scottish Government

09.30 – 11.00Sustainability, single use, reprocessing, re-use, remanufacture, conformity assessment, circular economy/life cycle analysis             

Lena Cordie-Bancroft, BSI KS Sector Lead, Medical Devices

Heidi Barnard, Head of Sustainability, NHS Supply Chain

Clare Atkinson, Director of research & Development, NuGreen

Ami Newton, Senior Enterprise & Sustainability Manager, Medtronic

Alfred Casson tbc, Dept of Health & Social Care (DHSC), Design for Life

Samantha Smith, Director, Product Stewardship & Sustainability, Medtronic

11.00 – 11.30 Networking Tea/Coffee break

11.30 – 12.15     UK Designated Standards update, other relevant standards eg symbols, sterilisation, etc

EU Annex Z’s/Standardisation Request/Harmonisation 

Lena Cordie-Bancroft, BSI KS Sector Lead, Medical Devices

Richard Bancroft, Senior Director, Scientific, STERIS              

12.15 – 12.45     University Partnerships/Academia         

Emma Glass, University Partnerships Manager – Healthcare, BSI

Dr Irina Brass, Associate Professor, University College London

12.45 – 14.00 Networking lunch

14.00 – 15.00     Supply Chain, security of supply, multiple marks ie CE, UKCA etc, Economics,        

Helen Forsdyke, Senior Director Enterprise Regulatory Compliance, EMEA, Johnson & Johnson

Sharon Connor, Johnson & Johnson Director Environmental Sustainability

15.00 – 15.45     Innovation UK plans for future

Dr Camilla Fleetcroft, Strategy & Innovation Director, BSI

15.45 – 16.15     Data & Regulatory Science         

Rob Turpin, BSI KS Head of Sector – Healthcare

16.15 – 16.30     Final questions and close of conference              

Dr Michael Kipping, Director, Medical Technologies EMEAA, Element

CLOSE OF CONFERENCE  

Pricing

Member ticket: £500

Non member ticket: £1000

For more information, or to register, please click here.

Dawn