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SUMMARY:Webinar: Regulatory updates & industry perspectives on NAMs for Medical Device Safety
DESCRIPTION:Join us for an insightful webinar on the evolving role of New Approach Methodologies (NAMs) in regulatory biological safety assessments and how they can be used to help develop safe materials in the pre-regulatory space. With shifting standards and increasing adoption of NAMs\, understanding their impact is more critical than ever. \nIn this webinar\, Dr Andy Forreryd\, our expert in in vitro skin sensitization and active member of ISO/TC 194/WG 8\, will break down the latest regulatory updates on ISO 10993-10 and present new data from the GARD®skin Medical Device pre-validation study—a key milestone toward regulatory acceptance. \nYou will also hear from Dr Karla Lienau\, Biological Safety Specialist and Research Engineer at Sonova\, a global leader in Medical Devices\, on how NAMs are shaping product development\, ensuring compliance\, and accelerating innovation. \n \nKey takeaways\n\nRegulatory insights: Understand the latest developments in ISO 10993-10 and the role of in vitro methods.\nGARD® advancements: Learn how this technology supports skin sensitization testing for Medical Devices\, solid materials and extracts in both polar and non-polar vehicles.\nIndustry application: Discover how Sonova integrates NAMs into product development for novel materials.\n\nSpeakers \n \nAndy Forreryd\, PhD\nScientific Liaison @ SenzaGen \n\nExpert in in vitro assay development\, genomics\, and machine learning.\nCo-developer of the GARD®skin assay (OECD TG 442E).\nActive member of the ISO/TC 194/WG 8 on irritation and sensitization and OECD expert group on respiratory sensitization.\n\n\n \nKarla Lienau\, PhD\nBiological Safety Specialist and Research Engineer @ Sonova \n\nResearch engineer specializing in new materials\, coatings\, and technologies for custom hearing aids.\nExpertise in biological safety assessments in compliance with ISO 10993.\nWorks with Class IIa Medical Devices\, ensuring safety and regulatory compliance.\n\n  \n \nThe webinar will last around 50 minutes\, followed by a live Q&A. If you cannot attend the live event\, register now to get access to the recording.
URL:https://senzagen.com/event/webinar-regulatory-updates-nams-for-medical-devices/
CATEGORIES:Webinar
ATTACH;FMTTYPE=image/jpeg:https://senzagen.com/wp-content/uploads/2025/01/Lime-UNIVERSAL-webinar.jpg
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DTSTART;TZID=Europe/Stockholm:20250316T080000
DTEND;TZID=Europe/Stockholm:20250320T170000
DTSTAMP:20250312T122014Z
CREATED:20250207T084353Z
LAST-MODIFIED:20250312T122014Z
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SUMMARY:2025 SOT Annual Meeting & ToxExpo
DESCRIPTION:Booth #637 \nOrange County Convention Center\,  Orlando\, FL. \nMeet us and discover how the GARD® assays are transforming skin sensitization testing. Learn about their role in filling data gaps for in vitro skin sensitizing hazard and quantitative potency assessment\, providing a high-performing and ethical alternative to animal testing. \nExhibitor-Hosted Session\nAdvancing NAMs for Skin Sensitization Testing: Potency\, Challenging Substances and Medical Devices \nW208B | Tuesday\, 18 Mar | 10:45 am-11:45 am \n \n  \nBring your questions and testing challenges!\n \nJoin us for an interactive session that combines essential regulatory updates\, case studies\, and a live Q&A! Gain exclusive insights on the latest GARD®data from SenzaGen’s research and industry collaborations\, including key advancements in testing challenging substances\, medical devices\, and quantitative potency assessment. We will also share user cases from industry leaders like dōTERRA\, Clarins\, and Bic Skin Creative. \nOur experts will be available to discuss how GARD® innovations can address your needs and advance your work in skin sensitization testing. \nKey Topics \n\nNew GARD® data from industry collaborations on Natural Extracts and Quantitative Potency Assessment.\nRegulatory update WG8 ISO TC194: Medical Devices ISO 10993-10.\nUser Cases from dōTERRA\, Clarins\, Bic Skin Creative\, and more.\n\nSpeakers \n\nRon Brown\, Toxicologist at Risk Science Consortium (former FDA reviewer for Medical Devices)\nJoe Dawson\, Product Safety Manager at doTERRA International\nAndy Forreryd\, Scientific Liaison\, SenzaGen\n\nPosters\n🎫 G367 | Skin Sensitization Potency GHS/CLP Classification \nMarch 17\, 1:45 pm -4:15 pm | #3242 Subcategorization of skin sensitizers into UN GHS categories using GARD®skin Dose-Response \n🎫 D217 | Medical Devices Testing ISO 10993-10 \nMarch 19\, 9:15 am -11:45 am | #4382 Pre-validation Results from GARD®skin for Medical Devices: In Vitro Sensitization Testing of Medical Device Extracts for Implementation in ISO 10993-10 \n🎫 LB352 | NAMs in Occupational Health – Joint poster with Lundbeck \nMarch 20\, 8:30 am -11:30 am | #5251 Assessing skin sensitizing hazard of Drug Products and Active Pharmaceutical Ingredients using GARD®: New Approach Methodology in Occupational Health and Safety \n🎫 F310 |  Application for Pharmaceuticals – Joint poster presented by SafeBridge \nMar 18\, 1:45 pm-4 pm | #3838 Comparison of β-lactam ring containing substances gene expression signatures related to therapeutic mechanism and the Adverse Outcome Pathway (AOP) for sensitization \n 
URL:https://senzagen.com/event/2025sot/
LOCATION:Orlando\, Fl\, United States
CATEGORIES:Conference
ATTACH;FMTTYPE=image/png:https://senzagen.com/wp-content/uploads/2025/02/2025-SOT.png
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BEGIN:VEVENT
DTSTART;VALUE=DATE:20250326
DTEND;VALUE=DATE:20250328
DTSTAMP:20250317T083038Z
CREATED:20250303T114445Z
LAST-MODIFIED:20250317T083038Z
UID:34229-1742947200-1743119999@senzagen.com
SUMMARY:6th Annual BTEL Summit & Exhibition
DESCRIPTION:Meet us at the 6th Annual BTEL Summit & Exhibition in Berlin. \nOral presentation | 26 March \nBuilding confidence in New Approach Methodologies (NAMs) for biological safety testing of Medical Devices: a successful case study on skin sensitization testing using GARD®  \nAndy Forreryd\, PhD\nScientific Liaison Manager\, SenzaGen
URL:https://senzagen.com/event/btel2025/
LOCATION:Berlin\, Germany
CATEGORIES:Conference
ATTACH;FMTTYPE=image/png:https://senzagen.com/wp-content/uploads/2025/03/2025BTEL-1.png
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BEGIN:VEVENT
DTSTART;VALUE=DATE:20250331
DTEND;VALUE=DATE:20250402
DTSTAMP:20250317T085841Z
CREATED:20250303T115948Z
LAST-MODIFIED:20250317T085841Z
UID:34234-1743379200-1743551999@senzagen.com
SUMMARY:Forum SOFHYT 2025
DESCRIPTION:Meet us at the SOFHYT (French Society of Occupational Hygienists) forum “From Prevention to Action: The Occupational Hygienist at the Heart of Occupational Health Risk Management” in Paris on March 31 and April 1. \nOral presentation | 1 April
URL:https://senzagen.com/event/sofhyt2025/
LOCATION:Paris\, France
CATEGORIES:Conference
ATTACH;FMTTYPE=image/png:https://senzagen.com/wp-content/uploads/2025/03/Forum-SOFHYT.png
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