- email:registrations@informa-ls.com
- phone:+44(0)20 7017 7481
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Biocompatibility Testing and Evaluations for Medical Devices
6 - 7 December 2011
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3rd Annual Biocompatibility Testing and Evaluations for Medical Devices
Crucial updates and advice for risk management to ensure your devices are biocompatible
Featuring 15 new speakers, 5 case studies, 2 exciting workshops and an evening seminar featuring an FDA representative, this event brings together key biocompatibility industry experts with first-hand experience in biocompatibility testing and evaluations.
Don’t miss this opportunity to benchmark your biocompatibility testing and evaluation strategies against industry peers and get advice from 3 Notified Body representatives
Understand how to interpret ISO 10993:1 and improve yoru risk management strategies, plus get practical advice for implementing the chemical characterisation risk assessment approach.
Conference Highlights for 2011: Don't miss this chance to get the crucial updates you need to remain compliant and ensure your devices are biocompatible!
- Your chance to get an essential overview of ISO 10993 Part 1: Clarifying the grey areas read more
- FDA advice for implementing a new approach to biocompatibility evaluation read more
- Get a critical overview of clinical implications of wear particle production to find out how this fits in with biocompatibility testing read more
- Get advice from BSI to ensure successful biocompatibility submissions read more
- Get practical advice for conducting biocompatibility tests and evaluations for DDCPs read more
Three Additional Chances to Learn More About Biocompatibility!
Pre Conference Workshop X – Monday 5 December 2011
Conducting Evidence-Based Preclinical Assessments: Justifications for Biocompatibility Test Selections and Exemptions
Led by Daniel McLain, President, Walker Downey & Associates, Inc., USA
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Evening Seminar Y – Tuesday 6 December 2011
Exploring Global Interpretations of ISO 10993
Led by Nghia Nguyen, Pharmacist Manager, International Regulatory Affairs, Institut Straumann AG, Switzerland and Ron Brown, Toxicologist, FDA and Convener of ISO/TC 194/WG11, USA
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Post Conference Workshop Z – Thursday 8 December 2011
Finding the Best Biocompatibility Testing Strategies for Your Specific Device
Led by Daniel McLain, President, Walker Downey & Associates, Inc., USA
Exhibiting
Media Partners
Your expert speakers for 2011 include:
Your expert speakers for 2011 include:
Ron Brown
Toxicologist and Convener of ISO/TC 194/WG11
FDA
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Susanne Rubenwolf
Product Specialist
TUV SUD Product Service GmbH
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Lars Nord
Senior Scientist, Analytical Chemistry, Research
Q-Med AB
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Christine Skak
Senior BioSafety Specialist
Coloplast A/S
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Daniel McLain
President
Walker Downey & Associates, Inc.
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Dennis Jenke
Baxter Distinguished Scientist
Baxter Healthcare Corporation
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Event Sponsors
2011 Speaker Faculty Includes:
- Ron Brown, Toxicologist, FDA, and Convener of IOS/TC 194/WG11, USA
- Sabine Kloth, Senior Product Specialist, TUV SUD Product Service GmbH, Germany
- Liang Qian, Scheme Manager/Product Specialist, Ortho & Dental Team, BSI Healthcare, UK
- Susanne Rubenwolf, Product Specialist, TUV SUD Product Service GmbH, Germany
- Daniel McLain, President, Walker Downey & Associates, Inc., USA
- Lars Nord, Senior Scientist, Analytical Chemistry, Research, Q-Med AB
- Christine Skak, Senior Biosafety Specialist, Coloplast A/S
- Edward Reverdy, Director of Corporate Toxicology and Biocompatibility Services, Boston Scientific, USA
- Luca Orlandini, Medical Director Europe, Smith & Nephew AG, Switzerland
- Dennis Jenke, Baxter Distinguished Scientist, Baxter Healthcare Corporation, USA
- Nghia Nguyen, Pharmacist Manager, International Regulatory Affairs, Institut Straumann AG, Switzerland
- Adam Heroux, Manager II, Corporate Biocompatibility Services, Boston Scientific, USA
- XinLin Zu, Senior Project Microbiologist, Zimmer GmbH, Switzerland
- Manfred Maitz, Group leader Hemocompatibility, Leibniz Institute of Polymer Research Dresden, Max Bergmann Center of Biomaterials, Germany
New Case Study!
Case study: The Coloplast approach to phthalates
- The Coloplast opinion on phthalates in medical devices
- Getting an overview of phthalates in the product portfolio
- Documentation of safety of devices containing phthalates
- The Coloplast strategy on phthalates in medical devices
With Christine Skak, Senior BioSafety Specialist, Coloplast A/S
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