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DTSTART;TZID=Europe/Stockholm:20251202T160000
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DTSTAMP:20260916T081359
CREATED:20251119T084346Z
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SUMMARY:Webinar: The regulatory shift in biological safety testing
DESCRIPTION:NAMs for skin sensitization ISO 10993-10\nJoin us for an insightful webinar on the evolving role of New Approach Methodologies (NAMs) in biological safety testing of Medical Devices\, with a special focus on skin sensitization – the area currently undergoing the most significant regulatory changes. \nAs ISO standards advance toward reducing animal testing\, understanding these developments is essential for compliance and innovation. We will also touch on related endpoints\, including special irritation\, to provide a more complete perspective on biological safety testing. \nGARDskin: Full pre-validation data \nIn this session\, Dr. Andy Forreryd\, SenzaGen’s expert in in vitro skin sensitization and active member of ISO/TC 194/WG 8\, will share the latest regulatory developments in ISO 10993-10 and present new data from the completed GARD®skin Medical Device pre-validation study—a key milestone toward regulatory acceptance. \nSafe dose levels of potential sensitizers during R&D  \nYou will also gain practical insights from case studies with Sonova and Urgo\, showing how the GARD® technology can efficiently screen novel materials and determine safe levels of potential sensitizers in candidate devices.  \n \nThe webinar will last around 45 minutes\, followed by a live Q&A. If you cannot attend the live event\, register anyway to receive the on-demand recording. \nKey takeaways\n\nRegulatory insights: Stay informed on on the latest developments in ISO 10993-10 and the growing role of in vitro methods. \nGARD® advancements: Learn how GARD® supports both skin sensitization hazard and quantitative potency assessment of Medical Devices\, solid materials and extracts in polar and non-polar vehicles. \nIndustry application: Discover how GARD® is used in regulatory submissions for CE-marking\, early-stage material screening and hypoallergenicity claims.\n\nSpeaker\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  \n \n  \n\n 
URL:https://senzagen.com/event/webinar-regulatory-shift-in-biological-safety-testing/
CATEGORIES:Webinar
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