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DTSTART;VALUE=DATE:20251106
DTEND;VALUE=DATE:20251108
DTSTAMP:20251028T132753Z
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SUMMARY:3rd Annual Medical Device Biocompatibility Conference
DESCRIPTION:3rd Annual Medical Device Biocompatibility Conference\n Berlin\, Germany |  Nov 6-7\nCome meet us at this year’s Medical Device Biocompatibility Conference in Berlin\, where SenzaGen’s chief scientist Henrik Johansson will present recent progress in applying New Approach Methodologies (NAMs) for skin sensitization testing within the ISO 10993 framework\, including current regulatory developments and data from GARD®skin for Medical Devices. \nOur group company ToxHub will also present\, sharing insights on regulatory strategies for substance-based medical devices in line with MDR\, while VitroScreen will attend to discuss testing approaches\, including support for mode of action and classification. \nWant to connect with our scientific team while you’re there? \n \nPresentations\n“Building Confidence in New Approach Methodologies (NAMs) for Skin Sensitization Testing of Medical Devices”\n Thursday\, 6th Nov | 13:30 – 14:00 CET\n👤 Speaker: Dr Henrik Johansson\, Chief Scientist at SenzaGen\nKey takeaways:\n\nIntroduction to in vitro biocompatibility testing: Overview of available assays and their regulatory status.\nPre-validation data from GARD®skin for Medical Devices: In vitro skin sensitization testing of Medical Device Extracts for implementation in ISO 10993-10.\nRegulatory Developments in ISO 10993-10: Inclusion of in vitro methods.\nCase study: Integrating in vitro data into CE-marking submissions.\n\n\n“Biocompatibility evaluation of substance-based medical devices”\n Friday\, 7th Nov | 11:40 – 12:10 CET\n👤 Speaker: Dr Carla Landolfi\nKey takeaways:\n\nOverview of biocompatibility evaluation for substance-based medical devices under ISO 10993 and MDR.\nTesting strategies: in vitro\, in vivo\, and non-testing approaches.\nRegulatory challenges and best practices for ensuring patient safety.
URL:https://senzagen.com/event/3rd-annual-medical-device-biocompatibility-conference/
LOCATION:Berlin\, Germany
CATEGORIES:Conference
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DTSTART;TZID=Europe/Stockholm:20251119T160000
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SUMMARY:Webinar: GARDskin in OECD TG 497
DESCRIPTION:Bringing high performance and extended applicability to Defined Approaches for Skin Sensitization (DASS)\nJoin us for a special re-run of our popular webcast to learn more about the inclusion of GARD®skin in OECD TG 497 — what it means and how it can support your regulatory testing strategy. \nDefined Approaches for Skin Sensitization (DASS) is a key regulatory guideline for combining validated in vitro methods to support hazard and potency assessment. The GARDskin assay is now part of two Defined Approaches (DAs): \n\nThe “2 out of 3” DA for hazard identification.\nThe Integrated Testing Strategy (ITS) for hazard identification and potency sub-categorization (1A\, 1B\, NC).\n\nWith demonstrated high performance and broad applicability to hydrophobic substances (Log P > 3.5) and other challenging chemical entities\, GARDskin improves the performance and extends the overall applicability of DASS\, helping to fill data gaps in regulatory skin sensitization testing.   \n \nAgenda\n\nIntroduction to skin sensitization testing and GARD technology.\nGARDskin (OECD TG 442E) and its inclusion in OECD TG 497.\nCase studies: Improving performance and extending the applicability of DASS for challenging samples.\nLive Q&A.\n\nSpeakers \n \nAndy Forreryd\, PhD\nScientific Liaison Manager @ SenzaGen \n\nCo-developer of the GARD®skin assay (OECD TG 442E).\nMember of the ISO/TC 194/WG 8 on irritation and sensitization.\nMember of OECD expert group on respiratory sensitization. \n\n \nHenrik Johansson\, PhD\nChief Scientist @ SenzaGen \n\nCo-developer of the GARD®skin assay (OECD TG 442E).\nMember of the ISO/TC 194/WG 8 for Irritation and Sensitization.\nMember of the OECD Expert Group on Defined Approaches on Skin Sensitization.\n\n  \n \nThe webinar will last around 40 minutes\, followed by a live Q&A. If you cannot attend the live event\, register anyway to receive the on-demand recording. \n\n 
URL:https://senzagen.com/event/webinar-gardskin-in-oecd-497/
CATEGORIES:Webinar
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