15 - 18 June 2026
JW Marriott Hotel Berlin, Berlin, GermanyAttend In-Person or 100% Digitallykeyboard_arrow_right
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Day 3 - Wednesday 17th June - CEST Time Zone
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Biocompatibility - Day 3
08:55 - 09:00
Chairperson Remarks
09:00 - 09:30
Looking to the Future of Biological Safety Evaluations
- Ron Brown - Toxicologist, Risk Science Consortium
09:30 - 10:15
ISO 10993-1 2026 Updates: Risk Management as the Backbone of Biological Evaluation
- What has changed in practice since the 2025 update?
- How do regulators assess biological evaluation reports now?
- Exploring common pitfalls and come-backs
- Crystal D’Silva - Associate Director, Material Characterization and Assessment, Baxter
10:15 - 11:00
Life cycle approach: Re-shaping Biological Evaluation Within the Total Device Lifecycle
- How does biocompatibility converge with clinical evaluations and PMS in 2026?
- Diving into how a life cycle approach integrates biological evaluation into every stage of the medical device lifecycle, from design to post-market surveillance.
- Discussing strategies for aligning biological evaluation with evolving regulatory expectations and risk management practices.
- Marina Daineko - Biocompatibility Consultant, Intrinsic Medical Group
Showing 1 of 1 Streams
Biocompatibility - Day 3
11:30 - 12:00
US Perspective on 10993-1: FDA’s Approach To A Risk-based Mindset
- Understanding the FDA’s risk-based approach to ISO 10993-1 and its application in biological evaluation for medical devices.
- Exploring how manufacturers can align with FDA expectations by integrating risk management into their biocompatibility assessments.
- Sarah Belperain - Senior Biocompatibility Specialist/Toxicologist, Argon Medical Devices
12:00 - 12:30
When 10993-17 Is Not Sufficient – Building Alternative Toxicological Justifications
- Exploring scenarios where ISO 10993-17 may not fully address toxicological risk assessment needs for medical devices.
- Looking at how to develop alternative toxicological justifications using scientific data, literature, and risk-based approaches.
- Vera Dowling - Senior Principal Biocompatibility Manager, Cardinal Health
12:30 - 13:15
The Intersection of 10993-1 & 10993-1 – Chemical Characterisation & Toxicological Risk Assessment Deep Dive
- Diving into the critical connection between ISO 10993-1 and ISO 10993-17, focusing on chemical characterization and toxicological risk assessment
- Exploring methodologies for integrating chemical data with toxicological evaluations to ensure comprehensive biological safety assessments.
- Discussing practical insights into aligning chemical characterization and risk assessment processes with regulatory expectations.
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