Join 90+ biocompatibility professionals from 60+ medical device companies to exchange knowledge and share best practices while navigating the ever-changing regulatory landscape. Our conference brings together the largest number of key stakeholders, including Competent Authority and Notified Body. This is your chance to ask your burning questions face-to-face!
With the recent revisions to ISO 10993, the move towards alternatives for animal testing, and the deadline for EU MDR compliance closing in, we have put together a comprehensive agenda to help you navigate the most challenging regulatory and scientific complexities currently surrounding biocompatibility for medical devices to help you achieve the most efficient and effective route to compliance.
2019 boasts a 17 strong expert speaker line-up with fresh insight from key Working Groups, expertise you need to get to grips with what's new, and knowledge to help you work towards a more robust regulatory strategy.
1. Take control of your biocompatibility strategy
-Assess the latest alternatives to animal testing
-Hear Competent Authority and Notified Body feedback
-Assess harmonisation of ISO 10993 in EU, US, and China
-Gain clarification on the guidance surrounding chemical characterisation and toxicological risk assessment
2. Hear from ISO/TC 194 experts at the heart of ISO 10993
-Christian Pellevoisin, Scientific Director, Episkin Academy, France
-James Moore, Senior Scientist, W.L. Gore, USA
-Christopher Parker, Associate Department Head In-Vivo Biocompatibility, Toxikon, and member of ISO/TC 194/WG 10 Implantation working group
3. Get practical industry feedback to take back to the office
-Understand how to manage TTC
-Hear from Abbott on their work on Thrombogenicity Testing and the High Failure Rate
2-Day Conference Only (20-21 November, 2019): GBP 1899.0,
3-Day Conference (Includes Pre-Conference Workshop) (19-21 November, 2019): GBP 2499.0
Speakers: Pieter Van de Vijver, Non-Clinical Assessor, Medical Devices, FAMHPS, Christina Reufsteck, Product Specialist, TUV SUD Product Service GmbH, Germany, Philippe Hasgall, Principal Scientist, Zimmer Biomet, Switzerland, Anna Moeke-Knizhnik, Senior Manager Biocompatibility, Biotronik, James Moore, Ph.D., Senior Scientist, Biocompatibility, W.L. Gore and Associates Inc., USA, Jianfeng Hong, Senior Research Scientist and Chemistry Lab Manager, Fresenius Kabi, USA, Christian Pellevoisin, Scientific Director, Episkin Academy, Kent Grove, Principal Biocompatbility Scientist, Abbott, Philip Clay, Director, Chorley Consulting, Sonia Font Tellado, Study Director, Eurofins, Mollie Holter, Consultant and Owner, MicroBio Consulting, LLC, USA, Gerhard Marini, Team Leader, Biocompatibility and Sterility, R and D Impl. Development, MED-EL, Christopher Parker, Assoc. Department Head In-Vivo Biocompatibility, Toxikon, member of ISO/TC 194/WG 10 Implantation working group, Toxikon, Thor Rollins, Director of Toxicology and E and L Consulting, Nelson Labs, Henry Sibun, Director of Henry Sibun Associates Ltd, External Notified Body Reviewer/Lead Auditor, TUV SUD Product Service, UK, Annelies Vertommen, Team Leader, Medical Device Chemical Characterisation Testing, Nelson Labs NV, Wei Zhang, Senior Scientist, Medtronic Technology Center, Greater China