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DTSTART;TZID=Europe/Stockholm:20251202T160000
DTEND;TZID=Europe/Stockholm:20251202T170000
DTSTAMP:20251119T163704Z
CREATED:20251119T084346Z
LAST-MODIFIED:20251119T163704Z
UID:35877-1764691200-1764694800@senzagen.com
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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BEGIN:VEVENT
DTSTART;TZID=Europe/Stockholm:20260422T160000
DTEND;TZID=Europe/Stockholm:20260422T170000
DTSTAMP:20260401T071711Z
CREATED:20260327T081555Z
LAST-MODIFIED:20260401T071711Z
UID:36730-1776873600-1776877200@senzagen.com
SUMMARY:Webinar: Advancing NAMs for respiratory sensitization testing
DESCRIPTION:Scientific highlights from 2026 SOT\nJoin us for an insightful webinar exploring the latest advancements in respiratory sensitization testing\, an emerging field facing challenges in both scientific and regulatory landscapes. We will highlight how New Approach Methodologies (NAMs) are advancing human-relevant\, non-animal strategies for respiratory hazard assessment. \nTogether with guest speakers Dr. Emily Reinke (GDIT) and Dr. Joshua Vaughan (Merck)\, we will discuss key challenges\, outline currently available approaches\, and present new GARD®air data from scientific collaborations\, including results from a recently completed large-scale study (n=100) led by NICEATM\, as well as industry case studies on microbial-based pesticides and proteins. \nIf you missed SenzaGen’s scientific sessions at this year’s SOT in San Diego\, this is your chance to catch up!  \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: An up-to-date perspective on the evolving regulatory landscape for respiratory sensitization assessment. \nGARD® advancements: How genomics and machine-learning technologies enable non-animal respiratory sensitization assessment across diverse substance types. \nCase studies: Scientific collaborations with Merck and Bayer on proteins and microbial-based pesticides\, along with a NICEATM-led study on occupational health-related chemicals.\n\nSpeakers\n \nEmily Reinke\, PhD\, DABT\nPrincipal Toxicologist\, Federal Health Division | GDIT (contractor supporting NICEATM) \n\nExpert in NAMs for skin and respiratory sensitization and acute systemic toxicity.\nContributor to U.S. EPA\, JaCVAM\, OECD\, and independent peer review panels.\nFormer Department of Defense representative to ICCVAM (including four years as co-chair).\n\n  \n \nJoshua Vaughan\, PhD\, DABT\nPrincipal Scientist\, Occupational Toxicology and Product Stewardship\, Merck \n\nExpert in occupational and environmental health within pharmaceutical R&D.\nMember of the National Academies Committee on Toxicology.\nExtensive industry experience in toxicology across pharmaceuticals\, biocides/pesticides\, and product safety.\n\n  \n \nAndy Forreryd\, PhD\nScientific Liaison Manager\, SenzaGen \n\nMember of OECD expert group on respiratory sensitization.\nMember of the ISO/TC 194/WG 8 on irritation and sensitization.\nCo-developer of the GARD®skin assay (OECD TG 442E).\n\n  \n \n 
URL:https://senzagen.com/event/webinar-respiratory-sensitization-testing/
CATEGORIES:Webinar
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BEGIN:VEVENT
DTSTART;TZID=Europe/Stockholm:20260506T160000
DTEND;TZID=Europe/Stockholm:20260506T170000
DTSTAMP:20260504T180635Z
CREATED:20260421T130457Z
LAST-MODIFIED:20260504T180635Z
UID:36863-1778083200-1778086800@senzagen.com
SUMMARY:Webinar: In vitro skin sensitization potency assessment - Part 1
DESCRIPTION:New GARD® data on Fragrances\, Complex Mixtures\, and Biopesticides\nJoin us for the first webinar in a series focusing on in vitro skin sensitization potency assessment. In this opening session\, we will address common challenges in potency testing and highlight new GARD® data generated through scientific collaborations with dōTERRA and Bayer\, recently presented at the 2026 SOT Annual Meeting. \nYou will gain insight into typical use scenarios for GARD® skin Dose-Response\, and learn how this single-assay method\, based on genomics and machine-learning technology\, supports critical decision-making during product development\, including how to: \n\nDefine safe dose levels for materials with expected sensitizing potential.\nDerive reference NESIL values to support confirmatory human patch testing.\nEstablish a Point-of-Departure (PoD) for quantitative risk assessment.\n\nWith broad applicability to complex mixtures and novel raw materials with challenging properties\, GARD® provides a powerful non-animal solution for assessing skin sensitization potency. \n  \n \nKey topics\n\nIntroduction to the genomics and machine-learning based GARD® technology for quantitative skin sensitization potency assessment.\nCommon challenges in deriving PoDs and establishing safe dose levels for skin sensitizers.\nCase studies on Fragrances\, Complex Mixtures\, and Biopesticides.\n\nThe webinar will last around 30 minutes\, followed by a live Q&A. If you cannot attend the live event\, make sure to register to get access to the recording. \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 \nTim Lindberg\, PhD\nGARD® expert @ SenzaGen \n\nCo-developer of the GARD®skin assay (OECD TG 442E).\nExperienced scientist within immunology\, genomics\, and in vitro assay development.\n\n 
URL:https://senzagen.com/event/2026-webinar-in-vitro-skin-sensitization-potency-assessment-part-1/
CATEGORIES:Webinar
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BEGIN:VEVENT
DTSTART;TZID=Europe/Stockholm:20260603T160000
DTEND;TZID=Europe/Stockholm:20260603T170000
DTSTAMP:20260520T104309Z
CREATED:20260520T073159Z
LAST-MODIFIED:20260520T104309Z
UID:37020-1780502400-1780506000@senzagen.com
SUMMARY:Webinar: In vitro skin sensitization potency assessment - Part 2
DESCRIPTION:Difficult-to-test samples: Natural Complex Substances and Cosmetic Formulations\nJoin us for the second webinar in our series\, further exploring the challenges and opportunities of New Approach Methodologies (NAMs) for in vitro skin sensitization potency testing\, with a special focus on difficult-to-test substances. \nIn this session\, Dr Julie Anne Cote from The Honest Company\, Dr Isabelle Lee from the Research Institute for Fragrance Materials (RIFM)\, and Dr Andy Forreryd from SenzaGen will present new GARD® data and case studies on Natural Complex Substances and Cosmetic Formulations. \nYou will gain insight into how GARD® skin Dose-Response\, a single-assay method based on genomics and machine-learning technology\, performs on natural complex mixtures and supports critical decision-making during product development. Specifically\, you will learn how it can: \n\nDetect low levels of sensitizers in complex cosmetic formulations.\nDefine safe dose levels.\nGuide formulation optimization decisions.\n\nWith broad applicability to complex mixtures and novel raw materials with challenging properties\, GARD® provides a powerful non-animal solution for assessing skin sensitization potency. \n  \n \nKey topics\n\nIntroduction to the genomics and machine-learning based GARD® technology for in vitro skin sensitization potency assessment.\nPerformance evaluation of the GARD® skin Dose-Response assay for natural complex fragrance ingredients.\nCase studies on Natural Complex Substances and Cosmetic Formulations.\n\nThe webinar will last around 45 minutes\, followed by a live Q&A. If you cannot attend the live event\, make sure to register to get access to the recording. \nSpeakers\n  \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\nGARD® for in vitro skin sensitization potency assessment \n\n  \n \nIsabelle Lee\, PhD\nManager of Human Health Science & Strategy @ RIFM \n\nLeads human health science and strategy\, advancing NAMs for ingredient safety.\nHead of skin sensitization team\, overseeing safety assessments and research programs.\nExpert in consumer product ingredient evaluation with a PhD in Pharmacology (UPenn).\n\nAnalysis of natural complex fragrance ingredients in the GARDskin Dose-Response assay \n  \n \nJulie Anne Cote\, PhD\nSr. Clinical & Safety Compliance Research Scientist @ The Honest Company \n\nLeads safety\, clinical testing\, and product claim substantiation across multiple product categories.\nExpert in personal care and consumer goods safety compliance\, including baby care\, beauty\, and feminine hygiene.\nCombines scientific expertise and compliance leadership to effectively translate complex data into transparent\, science-backed consumer messaging.\n\nSkin sensitization potency assessment of complex cosmetic formulations \n 
URL:https://senzagen.com/event/2026-webinar-in-vitro-skin-sensitization-potency-assessment-part-2/
CATEGORIES:Webinar
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BEGIN:VEVENT
DTSTART;TZID=Europe/Stockholm:20261006T160000
DTEND;TZID=Europe/Stockholm:20261006T170000
DTSTAMP:20260924T074811Z
CREATED:20260923T132327Z
LAST-MODIFIED:20260924T074811Z
UID:37439-1791302400-1791306000@senzagen.com
SUMMARY:Webinar: In vitro skin sensitization potency assessment - Part 3
DESCRIPTION:Expert roundtable: How do we assess skin sensitization potency of Complex Mixtures?\nIndustry and scientific perspectives on current challenges\, emerging approaches and new data on Essential Oils\nHow can reliable skin sensitization potency estimates be generated for Natural Complex Substances and other complex mixtures using New Approach Methodologies (NAMs)? \nIn this webinar\, Joe Dawson\, Product Safety Manager at dōTERRA\, will present key findings from a recently published study comparing different approaches to quantitative potency assessment of Essential Oils. \nThe presentation will be followed by a live expert roundtable featuring speakers from dōTERRA\, the Research Institute for Fragrance Materials (RIFM)\, and SenzaGen. Together\, the panel will explore current challenges\, practical applications\, and future directions for skin sensitization potency assessment of complex mixtures. \nFor those who missed our EUROTOX session\, this webinar also offers an opportunity to hear the scientific rationale and key findings behind the newly published study. \nThe webinar presentations will last around 25 minutes\, followed by a 35-minutes live Q&A and expert roundtable discussion. If you cannot attend the live event\, register now to get access to the recording 🎧. \nWhat is your biggest challenge in skin sensitization potency assessment? Submit your question in the registration form and help shape the expert roundtable discussion. Selected questions and topics will be featured during the live session. \n  \n \nKey takeaways\n\nInsights from a newly published study comparing GARD® skin Dose-Response\, component-based prediction model\, and historical LLNA data for Essential Oils.\nCurrent challenges and opportunities in quantitative skin sensitization potency assessment of Complex Mixtures.\nExpert perspectives on practical applications\, challenges\, and future directions in NAM-based potency assessment.\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\nIntroduction to skin sensitization potency assessment and the single assay-based method GARD® skin Dose-Response. \n\n  \n \nJoe Dawson\nProduct Safety Manager @ dōTERRA\n \n\n12 years of experience as a research scientist in the food and cosmetics industries\nExpertise in product safety and scientific evaluation of consumer products\nB.Sc. in Molecular Biology\, University of Utah\, M.S. in Biomedical Informatics at the University of Utah School of Medicine (ongoing).\n\nA comparative analysis of test methods for predicting dermal sensitization potency in Essential Oils. \n  \n \nIsabelle Lee\, PhD\nManager of Human Health Science & Strategy @ RIFM\n \n\nLeads human health science and strategy\, advancing NAMs for ingredient safety.\nHead of skin sensitization team\, overseeing safety assessments and research programs.\nExpert in consumer product ingredient evaluation with a PhD in Pharmacology (UPenn).\n\n 
URL:https://senzagen.com/event/2026-webinar-in-vitro-skin-sensitization-potency-assessment-part-3/
CATEGORIES:Webinar
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BEGIN:VEVENT
DTSTART;TZID=Europe/Stockholm:20261028T160000
DTEND;TZID=Europe/Stockholm:20261028T170000
DTSTAMP:20261022T093939Z
CREATED:20261009T120435Z
LAST-MODIFIED:20261022T093939Z
UID:37548-1793203200-1793206800@senzagen.com
SUMMARY:Webinar: Advancing Medical Device Biocompatibility testing with NAMs
DESCRIPTION:Regulatory updates\, industry case studies\, and newly published evidence for wearable devices\nCan the “Big Three” be addressed using non-animal methods? Scientifically validated in vitro approaches are available to assess cytotoxicity\, skin irritation and skin sensitization\, supporting more predictive and human-relevant biocompatibility testing. As the regulatory landscape continues to evolve\, medical device manufacturers face growing opportunities to incorporate these methods into biocompatibility assessments and regulatory submissions. \nJoin us for a webinar exploring the latest developments within the ISO 10993 framework and how New Approach Methodologies (NAMs) are being applied in practice. We are also pleased to welcome Florian Gerdts\, Team Lead Process Development at Element 22\, who will present a case study on metallic 3D-printing materials. \nThrough regulatory perspectives and industry case studies\, our speakers will discuss how in vitro methods can support decision-making from early material screening to CE-marking submissions. \nJust published: We will also present findings from a newly published peer-reviewed study on wearable devices\, providing new evidence for the use of GARD® assays in assessing both constituents and finished-product leachables. \nBuild readiness\n• Develop your NAM database\n• Gain testing experience\n• Strengthen weight-of-evidence assessments \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 recording. \nKey takeaways\n\nRegulatory insights: Stay informed on the latest developments in ISO 10993-5\, ISO 10993-23 and 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 extractable medical devices and solid materials in polar and non-polar vehicles. \nIndustry application: Discover how NAMs are used as weight-of-evidence in CE-marking submissions\, testing of 3D-printed oral devices\, metallic 3D-printing materials\, and early-stage material screening.\nFeatured publication: “Assessing the skin sensitizing potential of constituents and leachables from wearable devices using GARD®” by Persaud et al. (Apple\, SenzaGen). Learn how the study applies GARD® assays to both wearable device constituents and finished-product leachables.\n\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 \nFlorian Gerdts\nTeam Lead Process Development @ Element 22 GmbH \n\nMaster of Materials Science and Engineering\, CAU Kiel\nTitanium Powder Metallurgy Expert\n> 14 years of experience in Titanium Pulver Metallurgy.\n\n  \n \n  \n\n 
URL:https://senzagen.com/event/webinar-medical-device-biocompatibility-testing-2026/
CATEGORIES:Webinar
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