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DTSTART;TZID=Europe/Stockholm:20240423T160000
DTEND;TZID=Europe/Stockholm:20240423T170000
DTSTAMP:20260417T094041
CREATED:20240321T085330Z
LAST-MODIFIED:20240325T130110Z
UID:32117-1713888000-1713891600@senzagen.com
SUMMARY:Webinar: Advancing NAMs for Skin Sensitization Testing
DESCRIPTION:Spotlight on Applicability Domain\, Quantitative Potency Assessment and Medical Devices\nIn case you missed SenzaGen’s poster presentations and scientific session at this year’s SOT\, we are pleased to offer you a new opportunity to participate on April 23\, 2024! \nIn this webinar Dr Andy Forreryd\, SenzaGen’s in vitro toxicology expert\, will summarize the latest GARD data from industry collaborations: \nCorteva Agriscience | ExxonMobil Biomedical Sciences | L’Oréal | IFF | RIFM | Inotiv | Johnson Matthey | Sonova | Duearity \nThe webinar will last around 50 minutes\, followed by a live Q&A. If you cannot attend the live event\, make sure to register to get access to the recording.  \nKey topics\n\nAgrochemical Formulations\nUVCBs and Formulated Lubricant Products\nComplex Mixtures\nMetals\nPoD for Quantitative Risk Assessment\nNESILs for Fragrance Materials\nRegulatory Acceptance According to MDR\nEarly-stage screening of materials intended for use in Medical Devices\n\nSpeakers\n \n  \n \n 
URL:https://senzagen.com/event/webinar-advancing-nams-for-skin-sensitization-testing/
CATEGORIES:Webinar
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Stockholm:20240207T160000
DTEND;TZID=Europe/Stockholm:20240207T170000
DTSTAMP:20260417T094041
CREATED:20240116T102331Z
LAST-MODIFIED:20240116T145019Z
UID:31853-1707321600-1707325200@senzagen.com
SUMMARY:Webinar: Spotlight on Difficult-to-Test samples
DESCRIPTION:Join our upcoming webinar to explore the recent advancement in GARD® for Skin Sensitization assessment\, with a specific focus on substances that fall outside the applicability domains of the conventional in vitro assays in the OECD Test Guidelines. \nOur skin sensitization experts will address challenges posed by various Difficult-to-Test substances\, discussing the applicability domain of key event-based NAMs and existing test strategies. \nYou will learn about the broad applicability of GARD®skin OECD TG442E as we present scientific data on Difficult-to-Test substances and exciting projects done in collaboration with industry partners: \nAgrochemical Formulations | Formulated Lubricant Products | Indirectly Acting Haptens | Metals | Natural Extracts | Polymers | UVCBs  \nThe webinar will last around 50 minutes\, followed by a live Q&A. If you cannot attend the live event\, make sure to register to get access to the recording.  \nKey takeaways\n\nNAMs and test strategies for skin sensitization testing of Difficult-to-Test samples.\nThe applicability domain of GARD®skin for challenging substances and its integration into Defined Approaches.\nCase studies on Agrochemical Formulations\, Formulated Lubricant Products\, Indirectly Acting Haptens\, Metals\, Natural Extracts\, Polymers\, and UVCBs.\n\nWhat are “difficult-to-test” substances?\nIn the context of skin sensitization testing\, certain groups of chemicals are considered difficult to test using conventional cell-based methods. Examples of commonly recognised “difficult-to-test” samples include indirectly acting haptens\, complex mixtures\, and substances with low water solubility. \nRead more about difficult-to-test substances. \nSpeakers\n \n  \n \n 
URL:https://senzagen.com/event/webinar-spotlight-on-difficult-to-test-samples/
CATEGORIES:Webinar
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Stockholm:20231214T160000
DTEND;TZID=Europe/Stockholm:20231214T170000
DTSTAMP:20260417T094041
CREATED:20231114T150216Z
LAST-MODIFIED:20231121T211556Z
UID:31504-1702569600-1702573200@senzagen.com
SUMMARY:Webinar: Safety of acrylate monomers\, metals\, and other materials used in medical device development
DESCRIPTION:Join our upcoming free webinar to explore the effective utilization of in vitro methods for safety assessment of materials during product development of Medical Devices.\nWe will discuss recent advancements in in vitro methods for assessing the endpoints of skin irritation and skin sensitization. Learn how to integrate these assessments into your product development process as a complement to chemical characterization and cytotoxicity testing. \nDiscover how this approach can aid in: \nSelecting the right material | Developing new materials | Optimizing production | Choosing the appropriate sterilization method\n\nKey takeaways\n\n*Gain insights into the key fundamentals of the biological evaluation of medical devices and the availability of in vitro biocompatibility testing. \n*Explore the applicability of the in vitro GARD technology in the assessment of medical devices\, supporting both polar and non-polar extraction vehicles (ISO 10993-12). \n*Examine user cases illustrating the safety assessment of acrylate monomers\, metals\, and various materials utilized in medical device development. Learn how these assessments contribute to material selection and production optimization. \n\nSpeakers\n\n \n 
URL:https://senzagen.com/event/webinar-safety-of-acrylate-monomers-metals-and-other-materials-used-in-medical-device-development/
CATEGORIES:Webinar
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Stockholm:20231018T160000
DTEND;TZID=Europe/Stockholm:20231018T170000
DTSTAMP:20260417T094041
CREATED:20231002T134126Z
LAST-MODIFIED:20231002T155151Z
UID:31216-1697644800-1697648400@senzagen.com
SUMMARY:Webinar: Latest GARD® innovation and research in in vitro skin and respiratory sensitization
DESCRIPTION:We invite you to participate in our webinar where new cutting edge GARD results will be explained by the experts at SenzaGen and our partners.\nIn case you missed SenzaGen’s Scientific Posters and Oral Presentations at this year’s WC12 in Niagara Falls or Eurotox in Ljubljana\, we are pleased to offer you a new opportunity to participate on Oct 18\, 2023! \nCome and join us to explore the most recent GARD® data on skin sensitization\, presented by Emily N Reinke from Inotiv-RTP\, a project done in collaboration with NIH and Burleson Research Technologies. \nAdditionally\, we will showcase our most recent collaborative projects with industry partners: \nMerck| Johnson Matthey | Corteva Agriscience | ExxonMobil Biomedical Sciences | International Flavors & Fragrances (IFF) | Duearity | Inotiv-RTP \n  \n \n  \nKey topics \n\nDifficult-to-Test Samples\nUVCBs and Formulated Lubricant Products\nAgrochemical Formulations\nComplex Mixtures\nMetals\nQuantitative Potency Assessments\nRegulatory Acceptance According to MDR\nProtein Allergens\n\n  \nSpeakers \n \n  \nRegister here \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.\n\n 
URL:https://senzagen.com/event/webinar-latest-gard-innovation-and-research-in-in-vitro-skin-and-respiratory-sensitization/
CATEGORIES:Webinar
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Stockholm:20230612T160000
DTEND;TZID=Europe/Stockholm:20230612T170000
DTSTAMP:20260417T094041
CREATED:20230524T114652Z
LAST-MODIFIED:20230524T114819Z
UID:30777-1686585600-1686589200@senzagen.com
SUMMARY:Webinar: Time for a Change: Evidence-Based Approaches for the Biological Safety Assessment of Medical Devices
DESCRIPTION:Join this free webinar where Ron Brown\, toxicologist and former FDA risk assessor\, will outline the need for a new and more agile approach for the biological safety assessment of medical devices.\nThis presentation will identify the limitations associated with the current approach\, which largely relies on animal-based tests that may have questionable clinical relevance. It will also describe how new and existing biocompatibility test methods can be evaluated following the principles of an evidence-based toxicology (EBT).\nYou will also learn how to incorporate New Approach Methodologies (NAMs) into a streamlined workflow for the safety assessment of medical devices\, which may decrease the time needed for regulatory approval of a device.\n \nKey takeaways \n\nThe limitations associated with animal-based approaches used to assess the biological safety of medical devices.\nHow to assess the validity of NAMs by using an evidence-based toxicology (EBT) approach.\nHow to incorporate NAMs into a streamlined workflow for medical device safety assessment.\nA case study on the OECD approval of the in vitro assay GARDskin and its applicability for Medical Device assessments supporting both polar and non-polar extraction vehicles (ISO 10993-12).\n\nSpeakers \n \n\nRegister here \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.
URL:https://senzagen.com/event/webinar-time-for-a-change-evidence-based-approaches-for-the-biological-safety-assessment-of-medical-devices/
CATEGORIES:Webinar
ATTACH;FMTTYPE=image/jpeg:https://senzagen.com/wp-content/uploads/2023/05/Lime_webinarium_12-JUNE.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Stockholm:20230524T160000
DTEND;TZID=Europe/Stockholm:20230524T170000
DTSTAMP:20260417T094041
CREATED:20230510T075904Z
LAST-MODIFIED:20230511T080404Z
UID:30647-1684944000-1684947600@senzagen.com
SUMMARY:Webinar: Using in vitro data in your CE marking submission of Medical Devices
DESCRIPTION:Join this free webinar to learn how you can avoid animal testing and accelerate time to market by using results from in vitro testing for the endpoints of cytotoxicity\, skin irritation and skin sensitization in your biological evaluation for CE-marking of your medical device in line with the EU Medical Device Regulation 2017/745\, the MDR.\n\nKey takeaways \n\nAn introduction to how in vitro testing can be used in the biological evaluation of your medical device with focus on cytotoxicity\, skin irritation and skin sensitization according to MDR.\nThe unique and broad applicability of the OECD approved GARD® assay for skin sensitization testing\, supporting polar and non-polar extraction vehicles as recommended in ISO 10993-12.\nSeveral application examples and a class IIa product CE marking case study supporting ethical test solutions and faster time to market.\nExpert advisory and support in compilation of regulatory documentation for instance gap analysis of ISO standards\, Biological Evaluation Plan (BEP) and Biological Evaluation Report (BER).\n\nSpeakers \n \n\nRegister here\n\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.
URL:https://senzagen.com/event/webinar-using-in-vitro-data-in-your-ce-marking-submission-of-medical-devices/
CATEGORIES:Webinar
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Stockholm:20230426T160000
DTEND;TZID=Europe/Stockholm:20230426T170000
DTSTAMP:20260417T094041
CREATED:20230328T144209Z
LAST-MODIFIED:20230330T133759Z
UID:30497-1682524800-1682528400@senzagen.com
SUMMARY:SOT2023 Recap Webinar
DESCRIPTION:In case you missed SenzaGen’s Scientific Session at this year’s SOT\, here is a new opportunity! \nTogether with guest speakers from ExxonMobil Biomedical Sciences Inc. and Research Institute for Fragrance Materials\, Inc. (RIFM)\, SenzaGen’s Andy Forreryd\, PhD will present the latest GARD® data on quantitative risk assessment and regulatory testing of skin sensitizers\, and the potential to further broaden the GARD® applicability. \n\nKey topics\n\n·        Quantitative potency assessments\n·        UVCBs and formulated lubricant products\n·        Agrochemical formulations\n·        Acrylate monomers\n·        Regulatory acceptance according to MDR\n·        New application: Photosensitization \n  \n\nSpeakers\n\nAssessing the Utility of the GARD®skin Assay to Detect Dermal Sensitization Potential in UVCBs and Formulated Lubricant Products  \nAllison Greminger\, PhD\, DABT\nToxicology Associate @ExxonMobil Biomedical Sciences Inc.\nDr. Greminger is a board-certified toxicologist who provides scientific and regulatory support to several ExxonMobil Product Solutions businesses. In her current position\, she reviews and evaluates toxicological data to support regulatory compliance for current products\, as well as guide new product development. Dr. Greminger has a specific interest in local hazards relevant for formulated products and has conducted various research on implementing non-animal testing strategies to inform hazard potential. \n  \nAn introduction to photosensitization and why there is a need for development of predictive assays capable of discriminating between photosensitization and photoirritancy \n\nGretchen Ritacco\nPrincipal toxicologist @Research Institute for Fragrance Materials\, Inc. (RIFM)\nGretchen Ritacco leads the Photosafety program at the Research Institute for Fragrance Materials (RIFM). Her duties include evaluating fragrance materials in support of RIFM’s Fragrance Ingredient Safety Assessments and managing RIFM’s photoallergy research. In addition\, she is engaged in collaborations with industry leaders to investigate new approaches to evaluate the photoallergenic potential of fragrance materials. Before RIFM\, Gretchen worked in the Allergy and Asthma Discovery Research group at Schering Plough Research Institute. She evaluated lead development candidates for treating pulmonary disorders\, refined measurement of allergic airway disease\, and investigated markers of airway inflammation. Gretchen is a member of the Society of Toxicology (SOT) and both the European and American Societies of Photobiology (ESP & ASP\, respectively). \n\n  \nNew GARD data on skin sensitization testing: “difficult-to-test” substances and quantitative potency assessment and regulatory testing of Medical Devices \n\n​Andy Forreryd\, PhD\nScientific Liaison @ SenzaGen\nDr Forreryd has many years of experience working with in vitro assay development\, genomics and machine learning. He is also co-developer of the GARD platform for the assessment of chemical sensitizers and is the inventor of two patents related to the technology. \n 
URL:https://senzagen.com/event/2023-sot-recap-webinar/
CATEGORIES:Webinar
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Stockholm:20230222T160000
DTEND;TZID=Europe/Stockholm:20230222T170000
DTSTAMP:20260417T094041
CREATED:20230131T145829Z
LAST-MODIFIED:20230131T150057Z
UID:30336-1677081600-1677085200@senzagen.com
SUMMARY:Webinar: Overcoming challenges in skin sensitization testing with GARDskin OECD TG 442E
DESCRIPTION:Free webinar on Feb 22\, 2023 | 4pm CET | 10am EST \nTogether with guest speakers Dr Marco Corvaro\, Technical Team Leader\, Regulatory Toxicology at Corteva Agriscience and Gretchen Ritacco\, Principal Scientist at the Research Institute for Fragrance Materials (RIFM)\, we will discuss the challenges in skin sensitization testing and present new scientific data on agrochemical formulations\, “difficult-to-test” substances\, potency assessment and the potential to further broaden the applicability of the GARD assay to assess the endpoint of photosensitization. \n  \n \n\nAgenda \n\nChallenges in skin sensitization assessment.\nUpdate on the recent OECD approval of GARD®skin TG 442E.\nCase studies on “difficult-to-test” substances and quantitative potency assessment.\nCase study: Investigating the applicability domain of GARD®skin and GARD®potency for agrochemical formulations. Presented by Dr Marco Corvaro\, Corteva Agrisciences.\nNew application: An introduction to photosensitization and why there is a need for development of predictive assays capable of discriminating between photosensitization and photoirritancy.\n\n  \nThe webinar will last around 45 minutes\, followed by a live Q&A. If you cannot attend the live event\, register now to get access to the recording. \n  \nOvercoming challenges in skin sensitization testing with GARD®skin OECD TG 442E  \nThe field of skin sensitization assessment is rapidly evolving. New Approach Methodologies (NAMs) have been developed to increase predictivity\, broaden the applicability and to provide reliable quantitative and qualitative potency assessments. \nAs the first and only genomics and machine learning-based method\, GARDskin has been included into OECD Test Guideline 442E for in vitro skin sensitization. The scientific data published in the TG confirms the high performance and broad applicability of the method\, bringing new opportunities to the field of in vitro skin sensitization testing. \nPhototoxicity is a term used to describe chemicals which has the inherent potential to become photoactivated when exposed to UV-light\, giving rise to otherwise dormant adverse effects. Such effects may include both irritation and sensitization. In terms of risk management\, the distinction of the two types of chemicals is important\, as the hazardous exposure effects of photoirritants can be reduced by concentration limits\, whereas photoallergenic properties currently results in a ban of the chemical at hand. SenzaGen and the Research Institute for Fragrance Materials (RIFM) are collaborating to investigate and develop New Approach Methods (NAMs) for identification and discrimination of photosensitizers from photoirritants. Preliminary data from the incorporation of an UV-exposure step to the original protocol of GARDskin Dose-Response will be illustrated\, and the potential of this approach to simultaneously identify and distinguish between photosensitization and photoirritation will be discussed.  \n\nSpeakers \nDr Marco Covaro\nTechnical Team Leader\, Regulatory Toxicology at Corteva Agriscience\nDr Corvaro has more than 15 years of experience in the safety evaluation of regulated products in a variety of industry sectors. He is a European Registered Toxicologist (ERT) and works as technical lead in Regulatory Toxicology at Corteva. He also acts as the group focal point for activities in the 3R area\, including reduction and alternatives to animal toxicity testing and has been part of several technical expert groups at OECD\, EChA\, ECETOC\, EPAA\, CLE (previously ECPA and EuropaBio) aimed at scientific consensus building and science communication within the regulatory community. \nGretchen Ritacco\nPrincipal Scientist\, Dermatotoxicology at RIFM\nGretchen Ritacco leads the Photosafety program at the Research Institute for Fragrance Materials (RIFM). Her duties include evaluating fragrance materials in support of RIFM’s Fragrance Ingredient Safety Assessments and managing RIFM’s photoallergy research. In addition\, she is engaged in collaborations with industry leaders to investigate new approaches to evaluate the photoallergenic potential of fragrance materials. Before RIFM\, Gretchen worked in the Allergy and Asthma Discovery Research group at Schering Plough Research Institute. She evaluated lead development candidates for treating pulmonary disorders\, refined measurement of allergic airway disease\, and investigated markers of airway inflammation. Gretchen is a member of the Society of Toxicology (SOT) and both the European and American Societies of Photobiology (ESP & ASP\, respectively). \nDr Andy Forreryd\nScientific Liaison at SenzaGen\nDr Forreryd has many years of experience working with in vitro assay development\, genomics and machine learning. He is also co-developer of the GARD platform for the assessment of chemical sensitizers and is the inventor of two patents related to the technology. \n\nREGISTER NOW\n\n 
URL:https://senzagen.com/event/webinar-overcoming-challenges-in-skin-sensitization-testing-with-gardskin-oecd-tg-442e/
CATEGORIES:Webinar
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Stockholm:20230124T160000
DTEND;TZID=Europe/Stockholm:20230124T170000
DTSTAMP:20260417T094041
CREATED:20221118T150607Z
LAST-MODIFIED:20230120T152436Z
UID:30122-1674576000-1674579600@senzagen.com
SUMMARY:Webinar: Safety and Efficacy Evaluation of Cosmetic Products and Ingredients
DESCRIPTION:How to integrate innovative in vitro test methods\nIn this joint webinar\, we will present an overview of innovative in vitro methods and how to integrate them into the evaluation of safety and efficacy of cosmetic products and ingredients. The webinar will start with a recorded presentation followed by a live Q&A session. If you cannot attend the live event\, register now to get access to the recording. \n  \n \nKey topics and speakers\n \n\nRegister now
URL:https://senzagen.com/event/webinar-safety-and-efficacy-evaluation-of-cosmetic-products-and-ingredients/
CATEGORIES:Webinar
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Stockholm:20221026T160000
DTEND;TZID=Europe/Stockholm:20221026T170000
DTSTAMP:20260417T094041
CREATED:20220830T120449Z
LAST-MODIFIED:20221017T122725Z
UID:29801-1666800000-1666803600@senzagen.com
SUMMARY:Webinar: How to use in vitro assays in your biological evaluation
DESCRIPTION:In this webinar\, our Medical Device and ISO expert Dr Rose-Marie Jenvert will tell you more about how you can use in vitro methods for the biological evaluation of medical devices\, now offered at our GLP-certified laboratories. She will also introduce you to our expanded medical device offering and how we can help you to comply with MDR. \nThe webinar will last around 45 minutes\, followed by a live Q&A. Even If you cannot attend the live event\, make sure to register to get access to the recording. \n  \n  \n\nKey takeaways\n\nAttendees will gain insights into: \n💡 In vitro biocompatibility testing now in ISO 10993 \n💡 GARD® compatible with both saline and oil \n💡 GARD® for quantitative potency assessment during product development \n💡 3Rs strategy in compliance with MDR Rule 21  \n\nSpeaker\n\n \n\nHighly accurate and ethical alternatives \nAn exciting evolution is ongoing in the medical device toxicology field\, transitioning from a process that largely relied on the results of animal testing to one which is increasingly focused on the use of in vitro methods for the safety assessment of medical device materials. A big step towards replacing animal testing for medical devices was taken when in vitro skin irritation testing using Reconstructed human Epidermis (RhE) tissue was implemented in the ISO 10993-23 standard published earlier this year. Moreover\, in vitro assays for skin sensitization have been included in the updated ISO 10993-10. \nIn vitro biocompatibility package \nOur GLP-certified laboratories offer an in vitro biocompatibility package that includes testing of the three endpoints that need to be evaluated for all medical device products: cytotoxicity\, skin irritation and skin sensitization\, providing a solution for customers looking for a highly accurate and ethical alternative for testing of materials and medical devices. \nCytotoxicity \nThe endpoint cytotoxicity can be tested in vitro using qualitative and quantitative test methods as described in ISO 10993-5:2009 and have a history of use both for regulatory purposes and as a screening tool early in the product development phase. \nSkin irritation \nThe endpoint skin irritation using RhE-tissue according to ISO 10993-23:2021 provides human-relevant results with higher accuracy and fewer false-positive results compared to the rabbit model. \nSkin sensitization with GARD®  \nThe endpoint skin sensitization can be assessed in vitro using the GARDskin Medical Device assay\, based on a state-of-the-art technology GARD; including human immunological cells\, a specific genomic biomarker signature and a machine learning-assisted classification model. The GARDskin Medical Device assay enables the medical device industry to perform in vitro skin sensitization testing of both saline and oil extracts from devices or materials as described in ISO 10993-12 and  10993-10:2021\, thus mimicking the intended use of the device when in contact with skin.  \n\nRegister now
URL:https://senzagen.com/event/webinar-how-to-use-in-vitro-assays-in-your-biological-evaluation/
CATEGORIES:Webinar
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Stockholm:20221012T160000
DTEND;TZID=Europe/Stockholm:20221012T170000
DTSTAMP:20260417T094041
CREATED:20220920T133458Z
LAST-MODIFIED:20220923T095041Z
UID:29883-1665590400-1665594000@senzagen.com
SUMMARY:Webinar: Recap on SenzaGen’s 2022 ICT Scientific Session
DESCRIPTION:New GARD® data on agrochemicals\,”difficult-to-test” substances and potency assessments\n\n – In vitro skin sensitization testing: New opportunities for hazard and quantitative potency assessment using genomics and machine learning technology\nIn case you missed SenzaGen’s scientific session at this year’s ICT\, we are pleased to offer you a new opportunity! We will present new scientific data on agrochemical formulations generated in collaboration with Corteva Agriscience\, “difficult-to-test” substances and potency assessment. \nThe webinar will last around 45 minutes\, followed by a live Q&A. If you cannot attend the live event\, register now to get access to the recording. \n  \n \n  \n \n  \n\nRegister now
URL:https://senzagen.com/event/webinar-recap-on-senzagens-2022-ict-industry-symposium/
CATEGORIES:Webinar
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Stockholm:20220713T160000
DTEND;TZID=Europe/Stockholm:20220713T170000
DTSTAMP:20260417T094041
CREATED:20220630T072933Z
LAST-MODIFIED:20220825T090554Z
UID:29536-1657728000-1657731600@senzagen.com
SUMMARY:Webinar: OECD update
DESCRIPTION:Join this live webinar led by our skin sensitization specialist Dr Andy Forreryd to learn the features and benefits of GARDskin and how the method can be used to fill data gaps during regulatory testing and product development. \n \nGARDskin approved by OECD\nWe are delighted to announce that SenzaGen’s GARDskin assay has been adopted by OECD as part of Test Guideline 442E for in vitro skin sensitization\, which is a regulatory breakthrough for the GARD technology. As the first and only genomics and machine learning-based method\, GARDskin has been approved for the third key event\, dendritic cell activation. The scientific data published in the TG confirms the high performance and broad applicability of the method\, bringing new opportunities to the field of in vitro skin sensitization testing. \nThe webinar will last around 30 minutes\, followed by a live Q&A. If you cannot attend the live event\, register now to get access to the recording. \nSpeakers\n \nRegister now
URL:https://senzagen.com/event/webinar-oecd-update/
CATEGORIES:Webinar
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BEGIN:VEVENT
DTSTART;TZID=Europe/Stockholm:20220525T160000
DTEND;TZID=Europe/Stockholm:20220525T170000
DTSTAMP:20260417T094041
CREATED:20220504T140953Z
LAST-MODIFIED:20220627T125525Z
UID:29411-1653494400-1653498000@senzagen.com
SUMMARY:Webinar: Medical devices' principal mode of action by physical means
DESCRIPTION:Case studies on 3D reconstructed human tissues\nThis webinar will showcase the opportunities offered by 3D reconstructed human tissues to demonstrate the physical mode of action of medical devices in line with the requirements and ethical criteria of the EU Medical Devices Regulation (MDR) 2017/745. \n\nKey takeaways\n\nAttendees will gain insights into: \n💡 How the principles of the 3Rs are applied in the MDR’s requirements. \n💡 How 3D reconstructed human tissues become a robust tool to define and demonstrate the principal mode of action of medical devices. \n💡 How to assess on a case by case approach the physical mode of action of medical devices according to their different therapeutic areas. \n  \n \nNew approach methodologies (NAMs) are driving the transition from animal testing to science-based decision-making for human risk assessment in the life sciences. This transition is aligned with EU Directive 2010/63 on the protection of animals used for scientific purposes and the principles of the 3Rs. \nWe’ll illustrate how NAMs are applied in the medical devices sector. The principles of the 3Rs were an important source of inspiration for the MDR.  ISO 10993 describing the Biological Evaluation of medical devices mandates that appropriate and scientifically validated in vitro methods be preferred over in vivo methods.  3D reconstructed human epidermis tissues can be used to assess skin irritation of medical device components and extracts (ISO 10993-23:2021). Additionally\, genomic-based test methods have been demonstrated to be promising solutions for the assessment of the skin sensitization potential of medical devices (ISO 10993-10:2021). \nManufacturers are required to provide scientific proof in their technical file for the qualification of their product as MD (MDCG 2022-5). They need to provide state-of-the-art scientific data regarding the principal mode of action of the MD. By definition\, this should be physical\, mechanical\, or chemical and cannot be pharmacological\, immunological\, or metabolic. As a result\, the demonstration of a physical mode of action became an essential requirement. The film-forming properties and bio-adhesivity of an MD can be demonstrated on 3D reconstructed human tissue models on a case-by-case approach to produce evidence of the MD’s physical mode of action. \nVitroScreen has developed and published an experimental procedure on reconstructed human epidermis for film-forming assessment. With this as a basis\, we propose protocols optimized for each specific therapeutic area by selecting the tissues on which the MD is intended to act and defining a treatment procedure that mirrors realistic conditions of use. We will present case studies based on different formulation types suitable for gastroenterology\, gynecology\, ophthalmology\, oral care\, urology\, and the respiratory tract. \n  \n\nSpeakers\n\n \n \n  \n\nRegister now
URL:https://senzagen.com/event/webinar-medical-devices-principal-mode-of-action-by-physical-means/
CATEGORIES:Webinar
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BEGIN:VEVENT
DTSTART;TZID=Europe/Stockholm:20220428T160000
DTEND;TZID=Europe/Stockholm:20220428T170000
DTSTAMP:20260417T094041
CREATED:20220331T075055Z
LAST-MODIFIED:20220627T125547Z
UID:29263-1651161600-1651165200@senzagen.com
SUMMARY:Webinar: Recap on SenzaGen’s 2022 SOT Scientific Session
DESCRIPTION:New GARD® data on agrochemical formulations\, fragrance materials\, medical devices and metals\n\n – Skin sensitization: using in vitro tools for quantitative potency assessment as an alternative to the Local Lymph Node Assay\nIn case you missed SenzaGen’s scientific session at this year’s SOT\, here is a new opportunity! \nTogether with guest speakers from Takasago and Sonova\, we will present the latest user cases where the in vitro GARD assays have been used for skin sensitization testing with a focus on the quantitative potency assessment. New GARD data on agrochemical formulations\, fragrance materials\, medical devices and metals will be presented. \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. \n  \n \nAgenda\n \n\nRegister now
URL:https://senzagen.com/event/webinar-recap-on-senzagens-2022-sot-exhibitor-hosted-session/
CATEGORIES:Webinar
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BEGIN:VEVENT
DTSTART;TZID=Europe/Stockholm:20220217T160000
DTEND;TZID=Europe/Stockholm:20220217T170000
DTSTAMP:20260417T094041
CREATED:20211209T154800Z
LAST-MODIFIED:20220204T125454Z
UID:28308-1645113600-1645117200@senzagen.com
SUMMARY:Webinar: Safer Medical Devices - In vitro assays as part of your biological evaluation
DESCRIPTION:In this webinar\, our Medical Device and ISO expert Dr Rose-Marie Jenvert will tell you more about how you can use in vitro methods for the biological evaluation of medical devices\, now offered at our GLP certified laboratories. She will also introduce you to our expanded medical device offering and how we can help you to comply with MDR. \nThe webinar will last around 45 minutes\, followed by a live Q&A. Even If you cannot attend the live event\, make sure to register to get access to the recording. \nKey topics\n\nHow you can use in vitro assays for biocompatibility testing of medical devices: cytotoxicity\, skin irritation and sensitization.\nThe broad applicability and high accuracy of the GARD sensitization assay\, supporting both polar and non-polar extraction vehicles (ISO 10993-12).\nUser cases on skin sensitization assessment of medical devices.\n\n \nSpeaker\n \n\nHighly accurate and ethical alternatives \nAn exciting evolution is ongoing in the medical device toxicology field\, transitioning from a process that largely relied on the results of animal testing to one which is increasingly focused on the use of in vitro methods for the safety assessment of medical device materials. A big step towards replacing animal testing for medical devices was taken when in vitro skin irritation testing using Reconstructed human Epidermis (RhE) tissue was implemented in the ISO 10993-23 standard published earlier this year. Moreover\, in vitro assays for skin sensitization have been included in the updated ISO 10993-10. \nIn vitro biocompatibility package \nOur GLP certified laboratories offer an in vitro biocompatibility package that includes testing of the three endpoints that need to be evaluated for all medical device products: cytotoxicity\, skin irritation and skin sensitization\, providing a solution for customers looking for a highly accurate and ethical alternative for testing of materials and medical devices. \nCytotoxicity \nThe endpoint cytotoxicity can be tested in vitro using qualitative and quantitative test methods as described in ISO 10993-5:2009 and have a history of use both for regulatory purposes and as a screening tool early in the product development phase. \nSkin irritation \nThe endpoint skin irritation using RhE-tissue according to ISO 10993-23:2021 provides human-relevant results with higher accuracy and fewer false-positive results compared to the rabbit model. \nSkin sensitization with GARD™ \nThe endpoint skin sensitization can be assessed in vitro using the GARDskin Medical Device assay\, based on a state-of-the-art technology GARD; including human immunological cells\, a specific genomic biomarker signature and a machine learning-assisted classification model. The GARDskin Medical Device assay enables the medical device industry to perform in vitro skin sensitization testing of both saline and oil extracts from devices or materials as described in ISO 10993-12 and  10993-10:2021\, thus mimicking the intended use of the device when in contact with skin.  \n\nRegister now
URL:https://senzagen.com/event/webinar-biological-evaluation-of-medical-devices-using-in-vitro-methods/
CATEGORIES:Webinar
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BEGIN:VEVENT
DTSTART;TZID=Europe/Stockholm:20220120T160000
DTEND;TZID=Europe/Stockholm:20220120T170000
DTSTAMP:20260417T094041
CREATED:20211209T154427Z
LAST-MODIFIED:20220105T083742Z
UID:28303-1642694400-1642698000@senzagen.com
SUMMARY:Webinar: Why Choose GARD™ for Skin Sensitization Testing?
DESCRIPTION:High performance\, broad applicability\, quantitative potency\n\nJoin us for this webinar to get the latest news about the in vitro GARD assays and how they are used to fill data gaps and address challenges in skin sensitization testing\, such as “difficult-to-test” substances\, quantitative potency assessment\, testing of medical devices and solid materials. \n \nKey topics\n\nAn introduction to GARD: How the genomic and machine learning-based technology works and its applications\nCase studies: “Difficult-to-test” samples such as complex mixtures\, pre/pro- haptens and substances with low water solubility\nCase studies: In vitro skin sensitization assessment of medical devices using both saline and oil as extraction vehicles\nCase studies: In vitro quantitative potency assessment as an alternative to LLNA\n\nThe webinar will last around 40 minutes\, followed by a live Q&A. If you can’t attend the live event\, register now to get access to the recording.  \nSpeakers\n \n \n  \nRegister now
URL:https://senzagen.com/event/webinar-why-choose-gard-for-sensitization-testing-2/
CATEGORIES:Webinar
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BEGIN:VEVENT
DTSTART;TZID=Europe/Stockholm:20211214T160000
DTEND;TZID=Europe/Stockholm:20211214T170000
DTSTAMP:20260417T094041
CREATED:20211209T135308Z
LAST-MODIFIED:20211209T135357Z
UID:28292-1639497600-1639501200@senzagen.com
SUMMARY:SaferWorldbyDesign Webinar: Skin safety assessment according to OECD guidelines
DESCRIPTION:Join our skin sensitization expert Dr Andy Forreryd at this SaferWorldbyDesign webinar & panel discussion to learn more about skin safety assessment. \n  \nRead more and register here \n 
URL:https://senzagen.com/event/saferworldbydesign-webinar-skin-safety-assessment-according-to-oecd-guidelines/
CATEGORIES:Webinar
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BEGIN:VEVENT
DTSTART;TZID=Europe/Stockholm:20211118T160000
DTEND;TZID=Europe/Stockholm:20211118T170000
DTSTAMP:20260417T094041
CREATED:20210930T080606Z
LAST-MODIFIED:20211021T122341Z
UID:27696-1637251200-1637254800@senzagen.com
SUMMARY:Webinar: Safety Testing of Cosmetic Products
DESCRIPTION:An Overview of Established Methods and New Approach Methodologies (NAMs)\nIn this joint webinar\,  we will present an overview of established methods and New Approach Methodologies (NAMs) used in the safety testing of cosmetic products. The webinar will start with a recorded presentation followed by a live Q&A session. If you cannot attend the live event\, register now to get access to the recording. \n  \n \nKey topics and speakers\n \n\nRegister now
URL:https://senzagen.com/event/webinar-safety-testing-of-cosmetic-products/
CATEGORIES:Webinar
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BEGIN:VEVENT
DTSTART;TZID=Europe/Stockholm:20211111T160000
DTEND;TZID=Europe/Stockholm:20211111T170000
DTSTAMP:20260417T094041
CREATED:20211011T163155Z
LAST-MODIFIED:20211011T163155Z
UID:27835-1636646400-1636650000@senzagen.com
SUMMARY:Webinar: Recap on SenzaGen's Eurotox Industry Symposium
DESCRIPTION:Filling data gaps in skin sensitization testing: In vitro hazard and potency assessment using GARD\nIn case you missed SenzaGen’s industry symposium at this year’s Eurotox Virtual Congress\, here is a new opportunity! Together with guest speakers from Corteva Agriscience and Essity Hygiene & Health\, we will present customer cases where the in vitro GARD assays have been successfully utilized to fill data gaps in skin sensitization hazard and potency testing. The webinar will last around 50 minutes\, followed by a live Q&A. Even If you cannot attend the live event\, register now to get access to the recording. \n  \n \nAgenda and featured speakers\n \n  \n\nRegister now\n\n 
URL:https://senzagen.com/event/webinar-recap-on-senzagens-eurotox-industry-symposium/
CATEGORIES:Webinar
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BEGIN:VEVENT
DTSTART;TZID=Europe/Stockholm:20211013T160000
DTEND;TZID=Europe/Stockholm:20211013T170000
DTSTAMP:20260417T094041
CREATED:20210906T094522Z
LAST-MODIFIED:20210906T123106Z
UID:27554-1634140800-1634144400@senzagen.com
SUMMARY:Webinar: Safer Medical Devices – In Vitro Assays As Part of a Biological Evaluation
DESCRIPTION:In this webinar\, the speakers will discuss the uses of in vitro assays as a part of the risk assessment and biological evaluation for the following endpoints: cytotoxicity\, skin irritation and skin sensitization. \nKey topics\nThe presentation will introduce biological evaluation and biocompatibility testing of medical devices\, with focus on in vitro assays for skin irritation and skin sensitization now implemented in the ISO 10993-23:2021 and ISO/FDIS 10993-10:2021. For assessment of skin sensitization\, the GARD™-technology will be introduced and the speakers will discuss how it can be used as a part of a biological evaluation. \nThe webinar will conclude with customer cases where in vitro assays\, including GARDskin Medical Device assay and GARDskin Dose-Response\, have been successfully utilized for risk assessment as part of the biological evaluation and for risk-based decision-making in compliance with the principles of the 3Rs throughout the product life cycle. \n  \n \nSpeakers\n  \n\nA highly accurate and ethical alternative \nAn exciting evolution is ongoing in the medical device toxicology field\, transitioning from a process that largely relied on the results of animal testing to one which is increasingly focused on the use of in vitro methods for the safety assessment of medical device materials. A big step towards replacing animal testing for medical devices was taken when in vitro skin irritation testing using Reconstructed human Epidermis (RhE) tissue was implemented in the ISO 10993-23 standard published earlier this year. Moreover\, in vitro assays for skin sensitization have been included in the updated ISO 10993-10. \nIn vitro biocompatibility package \nThe in vitro biocompatibility package includes testing of the three endpoints that need to be evaluated for all medical device products: cytotoxicity\, skin irritation and skin sensitization\, offering a solution for customers looking for a highly accurate and ethical alternative for testing of materials and medical devices. \nCytotoxicity \nThe endpoint cytotoxicity can be tested in vitro using qualitative and quantitative test methods as described in ISO 10993-5:2009 and have a history of use both for regulatory purposes and as a screening tool early in the product development phase. \nSkin irritation \nThe endpoint skin irritation using RhE-tissue according to ISO 10993-23:2021 provides human relevant results with higher accuracy and less false positive results compared to the rabbit model. \nSkin sensitization with GARD™ \nThe endpoint skin sensitization can be assessed in vitro using the GARDskin Medical Device assay\, based on a state-of-the-art technology GARD; including human immunological cells\, a specific genomic biomarker signature and a machine learning-assisted classification-model. The GARDskin Medical Device assay enables the medical device industry to perform in vitro skin sensitization testing of both saline and oil extracts from devices or materials as described in ISO 10993-12 and FDIS/ISO 10993-10:2021\, thus mimicking the intended use of the device when in contact with skin. \n\nRegister now
URL:https://senzagen.com/event/webinar-safer-medical-devices-in-vitro-assays-as-part-of-a-biological-evaluation/
CATEGORIES:Webinar
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Stockholm:20210916T160000
DTEND;TZID=Europe/Stockholm:20210916T170000
DTSTAMP:20260417T094041
CREATED:20210826T102829Z
LAST-MODIFIED:20210826T142827Z
UID:27453-1631808000-1631811600@senzagen.com
SUMMARY:Webinar: How is GARD used for skin sensitization testing?
DESCRIPTION:User cases on hazard and potency assessment\nGiven the huge interest in our previous webinar on GARD user cases\, we are pleased to offer you a new opportunity to hear how our customers use GARD to fill data gaps in sensitizing hazard and potency assessment of chemicals and medical devices. \n\nKey topics\nWe will provide several user cases on how the GARD assays have been used for skin sensitization testing to demonstrate: \n\nHazard assessment of “difficult-to-test” samples such as complex mixtures and surfactants.\nSensitization information for risk assessment of medical devices and solid materials.\nPotency determination for both CLP classification and product development.\n\nThe webinar should last around 40 minutes\, followed by a live Q&A. If you cannot attend the live event\, register now to get access to the recording of this webinar. \nSpeakers\n  \n\nRegister now
URL:https://senzagen.com/event/new-opportunity-how-is-gard-used-for-sensitization-testing/
CATEGORIES:Webinar
ATTACH;FMTTYPE=image/jpeg:https://senzagen.com/wp-content/uploads/2021/08/webinar-banner-cropped.jpg
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BEGIN:VEVENT
DTSTART;TZID=Europe/Stockholm:20210601T160000
DTEND;TZID=Europe/Stockholm:20210601T170000
DTSTAMP:20260417T094041
CREATED:20210525T093936Z
LAST-MODIFIED:20210525T094123Z
UID:27136-1622563200-1622566800@senzagen.com
SUMMARY:SaferWorldbyDesign Webinar: A novel in vitro approach for quantitative assessment of skin sensitizing potency
DESCRIPTION:This presentation will introduce GARDskin Dose-Response assay\, a novel approach for the assessment of relative skin sensitizing potency on a continuous scale. \nResults demonstrate that induction of toxicity pathways in GARDskin Dose-Response appears to be highly dose-dependent\, and the lowest concentration required to induce a positive classification in the assay correlates strongly and significantly with both LLNA EC3 and human NOEL values. \nA case study will be used to illustrate how the experimentally derived values from the GARDskin Dose-response assay can be used for CLP potency assessments\, potency rankings of potential candidate molecules\, or as a point of departure for quantitative risk assessment without having to revert to animal experimentation. \nFeatured Speakers\n\nAndy Forreryd\, PhD \nDr Andy Forreryd holds a Master of Science in molecular biotechnology from the Faculty of Engineering LTH at Lund University and a Doctor of philosophy in Immunotechnology from Lund University. He has many years of experience working with in vitro assay development\, genomics\, and machine learning. He is co-developer of the GARD® platform for the assessment of chemical sensitizers and inventor of two patents related to the technology. \n  \nRead more and register here
URL:https://senzagen.com/event/saferworldbydesign-webinar-a-novel-in-vitro-approach-for-quantitative-assessment-of-skin-sensitizing-potency/
CATEGORIES:Webinar
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