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DTSTART;TZID=Europe/Stockholm:20230612T160000
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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
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DTSTART;VALUE=DATE:20230615
DTEND;VALUE=DATE:20230616
DTSTAMP:20230607T084110Z
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SUMMARY:Skin Sensitization by Altertox Academy
DESCRIPTION:This two days hands-on training is hosted by acCELLerate. \nSkin sensitization is a complex systemic process and since several years\, methods to replace animal tests have been validated and adopted by the OECD in this regard. These tests can be used as part of a weight-of-evidence or integrated using a Defined Approach (DA) to assess Skin Sensitization. \nAgenda\n09:55-10:25 GARD\, SenzaGen\n13:30-14:30 GARD – Case studies\, SenzaGen \nRegistration fee includes the participant booklet\, catering and social dinner. \nRegister here \n 
URL:https://senzagen.com/event/skin-sensitization-by-altertox-academy/
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DTSTART;VALUE=DATE:20230620
DTEND;VALUE=DATE:20230622
DTSTAMP:20230607T072928Z
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SUMMARY:MedTech Summit 2023
DESCRIPTION:Biocompatibility for Medical Devices\nTuesday\, 20 June 2023 12:00 – 12:30 \n\nThe GARDskin Medical Device assay for assessing the skin sensitizing potential of medical devices: A case study on the use of in vitro data in the biological evaluation for CE marking according to MDR\n\n\nA proof-of-concept study using the GARDskin Medical Device assay to evaluate the skin sensitizing potential of medical device materials using both polar and non-polar extraction vehicles (ISO 10993-12).\nA case study using in vitro data for the endpoints of cytotoxicity\, skin irritation and skin sensitization in the biological evaluation for CE-marking according to MDR to avoid animal testing while accelerating time to market\n\nSpeaker \n\n\nDr Andy Forreryd\nScientific Liason at SenzaGen
URL:https://senzagen.com/event/medtech-summit-2023/
LOCATION:Brussels\, Belgium
ATTACH;FMTTYPE=image/png:https://senzagen.com/wp-content/uploads/2023/06/MedTechSummit.png
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