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SUMMARY:Introduction to In Silico and In Silico Clinical Trials\, with Case Study Examples
DESCRIPTION:Discover how computational modelling and simulation can support clinical evidence generation for medical devices. \n22 October 2026 | 2:00 PM CET | Online \nAbout the Webinar\nIn silico methods are playing an increasingly important role in the way clinical evidence can be generated and assessed for medical devices. \nThis webinar will introduce the principles of in silico methods and in silico clinical trials\, exploring how computational modelling and simulation can complement traditional clinical evidence and contribute to regulatory decision-making. \nThrough practical examples and case studies\, participants will gain a clearer understanding of how in silico approaches can be integrated into evidence-generation strategies and where they may bring value alongside clinical data. \nThe session will be presented by Martha De Cunha Maluf-Burgman\, Leader of the Policy Development Working Group at the Avicenna Alliance\, in the context of the Alliance’s advocacy work. \nWhat We’ll Cover\nDuring this 90-minute webinar\, we will explore: \n\nThe fundamentals of in silico methods and in silico clinical trials\nHow computational evidence can complement traditional clinical evidence\nCurrent regulatory expectations for clinical evidence\nPractical case studies combining in silico and clinical data\nEmerging regulatory considerations\nOpportunities for incorporating computational approaches into evidence-generation strategies\n\nThe presentation will be followed by a live Q&A\, giving participants the opportunity to raise their questions and discuss the topic directly with the expert. \nWho Should Attend?\nThis webinar is particularly relevant for: \n\nRegulatory Affairs professionals\nClinical professionals and clinical trial managers\nR&D scientists\nMedical device and IVD manufacturers\nRegulators and Notified Bodies\nStudents and professionals interested in emerging approaches to clinical evidence generation\n\nWhy Attend?\nAs approaches to evidence generation continue to evolve\, understanding how computational methods can interact with traditional clinical evidence is becoming increasingly relevant. \nThis session provides an opportunity to explore the potential of in silico trials\, understand their place within the regulatory landscape\, and see through practical examples how computational and clinical evidence can work together. \nJoin us online on 22 October 2026 and explore the evolving role of in silico evidence in medical device clinical research. \nSpeaker\nMartha De Cunha Maluf-Burgman\nLeader of the Policy Development Working Group\, Avicenna Alliance \nPractical Information\n\nDate: 22 October 2026\nTime: 2:00 PM CET\nFormat: Online via Zoom\nRegistration Fee: Free for ICEPS members and 20€ for non-members (VAT excl.)\nZoom Access: The Zoom link and connection details will be sent by email.\nRecording: The session will be recorded\, and access to it will be only for ICEPS members.\n\n\nImportant Information\nPlease note that this event is a webinar only. \nParticipants will have the opportunity to ask questions and exchange directly with the expert speaker. \nThis session is not a training course\, and participation does not provide a certificate of attendance\, training completion\, or certification. \nYour Zoom access link is personal and may not be shared. Any participant not registered through ICEPS may be removed from the webinar without notice. \nThe session is recorded and only available for ICEPS members. \n 
URL:https://iceps-mdivd.org/event/introduction-to-in-silico-and-in-silico-clinical-trials-with-case-study-examples/
LOCATION:Zoom  Webinar
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DTSTART;TZID=Europe/Brussels:20261029T143000
DTEND;TZID=Europe/Brussels:20261029T153000
DTSTAMP:20261008T123637Z
CREATED:20260821T102058Z
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SUMMARY:Live Q&A Session on the New ISO 18969 with Danielle Giroud
DESCRIPTION:Your Questions on the New Clinical Evaluation Standard — Answered by the ISO Working Group Convenor \nDate: 29 October 2026 | Time: 14:00 CET\nFormat: Online Session (Zoom) \nThe publication of ISO 18969\, Clinical evaluation of medical devices\, marks an important development for professionals involved in the clinical evaluation of medical devices. As a new international standard\, ISO 18969 introduces principles and a structured process for planning and performing clinical evaluation throughout the medical device lifecycle. \nWith a new standard naturally come new questions: What does ISO 18969 mean in practice? How should its requirements and principles be interpreted? What should you consider when applying it to your clinical evaluation activities? \nThis live Q&A session is your opportunity to ask those questions directly to Danielle Giroud\, Convenor of the ISO Working Group responsible for ISO 18969. Drawing on her first-hand involvement in the development of the standard\, Danielle will address participants’ questions and provide insights into its principles\, intent and practical application. \nThe session will be dedicated to your questions. Participants are encouraged to ask questions live during the event or submit them in advance when registering (support@iceps-mdivd.org). Whether there is a particular section of the standard you would like to better understand\, a point you would like clarified\, or a practical challenge you are already considering\, this is the time to ask. \nTake advantage of this opportunity to discuss the newly published ISO 18969 with someone directly involved in its development and gain a clearer understanding of what the new standard means for clinical evaluation in practice. \nSpeakers\nDanielle Giroud\nFounder\, CEO\, MD-Clinicals & WMDO. \nWith close to 40 years of experience\, Ms. Danielle Giroud is an internationally recognized clinical research and regulatory expert within the global medical device industry. She has shared her extensive knowledge and experience with multi-national companies\, organizations\, and start-ups from around the world to help bring their products to market quickly and efficiently. \nMs. Giroud is also known for her contribution and engagement as founder and senior faculty board member of the World Medical Device Organization (WMDO). \nSince 2008 she is the convener for the expert group on clinical investigations (TC 194 WG4) for the ISO 14155 and clinical evaluation for the ISO 18969\, and functions as a liaison with the EU Commission – Clinical Investigation and Evaluation\, Performance Studies and Evaluation (CIEPSE) task force and other regulatory authorities throughout the world. \n  \nPractical Information\n\nDate: 29 October 2026\nTime: 14:00–15:30 CET\nDuration: 1 hour 30 minutes\nFormat: Online via Zoom\nRegistration Fee: Free for ICEPS members and 20€ for non-members (VAT excl.)\nZoom Access: The Zoom link and connection details will be sent by email.\nRecording: The session will be recorded\, and access to it will be only for ICEPS members.\n\nImportant Information\nPlease note that this event is a webinar only. \nParticipants will have the opportunity to ask questions and exchange directly with the expert speaker. \nThis session is not a training course\, and participation does not provide a certificate of attendance\, training completion\, or certification. \nYour Zoom access link is personal and may not be shared. Any participant not registered through ICEPS may be removed from the webinar without notice. \nThe session is recorded and only available for ICEPS members. \n 
URL:https://iceps-mdivd.org/event/live-qa-session-on-the-new-iso-18969-with-danielle-giroud/
LOCATION:Zoom  Webinar
ATTACH;FMTTYPE=image/png:https://iceps-mdivd.org/wp-content/uploads/2026/08/261029-QA-ISO-18969-1.png
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