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
09:00 - 09:05
Chairperson Remarks
09:05 - 09:35
Looking to the Future of Biological Safety Evaluations
- Ron Brown - Toxicologist, Risk Science Consortium
09:35 - 10:20
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
10:20 - 11:05
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
- Barbara Fink - Associate Director of Clinical Affairs, Heartstream
- Abigail Loneker - Senior Biological Safety Engineer, Philips
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Biocompatibility - Day 3
11:35 - 12:05
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
12:05 - 12:35
Developments in ISO 8250 and ISO 19227
- Boopathy Dhanapal - Convener of ISO/TC 194 WG 18, Independent Consultant
12:35 - 13:20
The Intersection of 10993-1 & 10993-18 – Chemical Characterisation & Toxicological Risk Assessment Deep Dive
- Diving into the critical connection between ISO 10993-1 and ISO 10993-18, 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.
- Philippe Hasgall - Research Associate Director, Biological Evaluation, Zimmer Biomet
- Beau Rollins - Head of Biocompatibility, ConvaTec
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