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08:00 - 09:00 60 mins
Main agenda
09:00 - 09:10 10 mins
Main agenda
Chair's opening remarks
  • Henry Sibun - Director, Henry Sibun Associates Ltd, and External Notified Body Reviewer/Lead Auditor for , TÜV SÜD Product Service GmbH, UK
09:10 - 09:45 35 mins
Main agenda
ISO 10993: What’s changed?
  • Albrecht Poth - Senior Toxicologist, Dr Knoell Consult/President of ISO TC194
  • An overview of the changes to the ISO 10993 
  • A discussion on why these changes have been implemented
  • A timeline for upcoming drafts and implementation including parts 1 and 4 


09:45 - 10:20 35 mins
Main agenda
In depth analysis of the recent changes to IS0 10993- 1
  • Barbara Musi - Principal Research Scientist, Baxter Healthcare +TC 194 working group
  • Detailed review of changes made the ISO 10993-1
  • A discussion to the changes of test point metric
  • Understanding how these changes will impact the tests needed for biocompatibility.
  • A focus on how to be ready for these changes
10:20 - 10:55 35 mins
Main agenda
An overview of the recent changes and developments to ISO 10993-4
  • Mike Wolf - Scientist and Technical Fellow, Medtronic + TC/194 Working group
  • Comprehensive understanding of the changes to the newly updated ISO 10993-4
  • The convener of the changes providing in depth feedback
  • Overcoming key challenges experience with ISO 10993-4
10:55 - 11:25 30 mins
Main agenda
Networking Break and Morning Coffee
11:25 - 11:55 30 mins
Main agenda
Hemocompatibility Testing: Challenges and New Developments
  • Deanna Porter - Global Biocompatibility, Abbott
  • Overview of Hemocompatibility Testing Challenges
  • Hemocompatibility Testing Developments
  • Future for Hemocompatibility Testing
11:55 - 12:25 30 mins
Main agenda
In vitro assessment of skin irritation of Medical Devices
  • Helena Kandarova - Executive Director, MatTek IVLSL
  • Current status of the skin irritation testing of MDs
  • Use of in vitro reconstructed 3D human skin models in the assessment of skin irritation
  • Information about validation status and ISO 10993 implementation
12:30 - 14:00 90 mins
Main agenda
Networking Lunch
14:00 - 14:35 35 mins
Main agenda
Explaining part ISO 10993- 18: What is required for successful chemical characterisation?
  • Jianwei Li - Senior Chemistry Manager/Medtronic Technical Fellow, Medtronic, Inc., USA
  • Exploring what tests are required for successful chemical characterisation
  • How will the upcoming changes to draft ISO 10993-18 affect the tests?
  • Practical advice for successful chemical characterisation
  • Moving away from a “tick box exercise” approach
14:35 - 15:10 35 mins
Main agenda
SPOTLIGHT SESSION: How to test medical devices as families ?
  • Sophie Michel PhD - Study Director Medical Devices, Toxikon
  • Integrating the AET concept
  •  Explaining the thought process behind test choices
  •  Discussing the hurdles faced during testing
15:05 - 15:40 35 mins
Main agenda
CASE STUDY: A discussion of extractables and leachables: adequate to replace in vivo testing?
  • Jianfeng Hong - Sr. Research Scientist / Chemistry Lab Manager, Fresenius Kabi, USA
  • Reviewing the impact of ISO 10993- 17 and 18 on extractables and leachables
  • Experienced advice on how to process results
  • An example success story for extractables and leachables for plastic
15:40 - 16:15 35 mins
Main agenda
Networking and Afternoon Tea
16:25 - 16:55 30 mins
Main agenda
Case Study: Ensuring biocompatibility safety with more difficult materials: One step closer a PVC-free blood bag
  • Lena Stigh - Project Manager, Region Jämtland Härjedalen.

Are you curious to know if the Life+ demonstration project PVCfreeBloodBag overcame its challenges?

Come and listen to project manager Lena Stig. She will tell you why and how they succeeded.

17:20 - 17:25 5 mins
Main agenda
Move to Plenary Room
17:25 - 18:00 35 mins
Main agenda
INSPIRATIONAL: For decades, Marc Koska OBE fought to stop the reuse of syringes

For decades, Marc Koska OBE fought to stop the reuse of syringes. One of the most impressive and inspirational entrepreneurs in the world, Marc faced and broke down bureaucratic barriers to fight one of the most virulent contributors to the spread of AIDS, with his non-retractable syringe, which was endorsed by the World Health Organisation in 2015. Sharing his story at a number of high calibre events, Marc's prolific work is truly inspirational and uplifting.