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DTSTART;TZID=Europe/Brussels:20261022T140000
DTEND;TZID=Europe/Brussels:20261022T153000
DTSTAMP:20261008T144300Z
CREATED:20260915T074849Z
LAST-MODIFIED:20261008T144300Z
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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
ATTACH;FMTTYPE=image/jpeg:https://iceps-mdivd.org/wp-content/uploads/2026/09/Visual.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Brussels:20261008T140000
DTEND;TZID=Europe/Brussels:20261008T153000
DTSTAMP:20261008T123550Z
CREATED:20260827T152615Z
LAST-MODIFIED:20261008T123550Z
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SUMMARY:Insights into the EU Joint Clinical Assessment (JCA) for Medical Devices and In Vitro Diagnostics
DESCRIPTION:Get ready for the new EU JCA framework and understand what it means for your evidence strategy. \n8 October 2026 | 2:00 PM CET | Online \nAbout the Webinar\nThe EU Joint Clinical Assessment (JCA) is introducing a new approach to the clinical assessment of certain medical devices and in vitro diagnostics at European level. \nBut what does this mean in practice for manufacturers? \nThis webinar will provide a clear overview of the JCA framework and its practical implications\, from the Joint Scientific Consultation (JSC) process to evidence scoping using the PICO framework. \nThe session will also explore how manufacturers can prepare early\, anticipate evidence expectations and build an evidence strategy that supports both European-level assessment and national market access decisions. \nWhat Will We Cover?\nDuring this 90-minute webinar\, we will explore: \n\nThe JCA process and key timelines\nJoint Scientific Consultation (JSC)\nEvidence scoping and the PICO framework\nKey challenges manufacturers should anticipate\nPractical considerations for early evidence planning\n\nThe session will conclude with a live Q&A\, giving participants the opportunity to discuss their questions directly with the experts. \nWho Should Attend?\nThis webinar is particularly relevant for professionals working in: \nRegulatory Affairs • Clinical Development • Market Access • HEOR • Medical Devices & IVDs • Health Technology Assessment \nSpeakers\nRachel Hoad\nDirector of Market Access\, Lightning Health \nRachel holds a PhD in Cell Physiology and Pharmacology from the University of Leicester and a First-Class Undergraduate Masters degree in Molecular and Cellular Biology from the University of Bath. \nRachel has over a decade of experience in market access consultancy\, working across pharmaceuticals\, medical devices\, drug-device combinations and digital health. Her therapy area expertise is varied and includes dermatology\, rare diseases\, oncology\, HIV and NASH. \nIn a previous roles she has been responsible for providing strategic oversight to research projects to ensure overall objectives were met. She has extensive project experience that ranges from mapping and understanding the European market for medical devices and diagnostics\, including TPP testing\, product positioning\, HTA and reimbursement landscapes\, procurement routes and price potential. \nAdam Ben Taied\nSenior Consultant\, Lightning Health \nAdam Ben Taieb: Adam holds a First-Class Honours Degree in Biomedical Science from the University of Surrey\, and an MSc in Science Communication from the University of Manchester. Adam has 7+ years experience working in the market access strategy and value communication field\, working with pharmaceutical and medical device companies throughout their products lifecycle\, to optimise their commercial potential\, value and market access strategy. \nAdam has experience in leading and delivering an extensive range projects\, from early disease landscaping\, pricing opportunity assessments and launch strategy development\, through to evidence generation\, value tools\, HTA submissions\, and stakeholder insights. His experience spans across numerous global markets as well as disease areas\, including rare diseases\, cardiology\, neurology\, respiratory\, diabetes etc. \nPractical Information\n\nDate: 8 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\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/insights-into-the-eu-joint-clinical-assessment-jca-for-medical-devices-and-in-vitro-diagnostics/
LOCATION:Zoom  Webinar
ATTACH;FMTTYPE=image/png:https://iceps-mdivd.org/wp-content/uploads/2026/08/261008-Insight-into-the-EU-Joint-Clinical-Assessment-.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Brussels:20260709T140000
DTEND;TZID=Europe/Brussels:20260709T153000
DTSTAMP:20260611T103533Z
CREATED:20260611T103348Z
LAST-MODIFIED:20260611T103533Z
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SUMMARY:ISO 14155:2026 – Risk Management for Clinical Investigations
DESCRIPTION:Live Q&A Session with Danielle Giroud\nDate: 9 July 2026 | Time: 14:00 CET\nFormat: Online Session (Zoom) \nThe publication of ISO 14155:2026 introduces significant updates to risk management and the conduct of clinical investigations. Understanding how to interpret and implement these new requirements can be challenging for manufacturers\, sponsors\, CROs\, investigators\, and quality and regulatory professionals. \nJoin Danielle Giroud\, Convenor of ISO/TC 194 Working Group 4\, for an exclusive live Q&A session dedicated to the practical implementation of the new standard. This session provides a unique opportunity to gain clarification directly from one of the experts involved in the development of ISO 14155:2026. \nParticipants will have the opportunity to discuss practical implementation challenges\, ask questions about specific requirements\, and better understand how to apply the updated expectations within their organizations. \nIn Collaboration with WMDO\nThis session is organized in collaboration with the World Medical Device Organization (WMDO)\, which offers dedicated training courses on ISO 14155:2026: \n\nhttps://wmdo.org/group/539\nhttps://wmdo.org/group/521\n\nParticipants who have completed one of these WMDO training courses may attend this Q&A session free of charge and do not need to register separately. \nWhat Participants Learn in the WMDO Courses\nThe WMDO training courses provide practical guidance on how to: \n\nTranslate ISO 14155:2026 requirements into real-world clinical investigation practice.\nUnderstand regulatory expectations and maintain compliance across global markets.\nStructure\, plan\, and manage clinical investigations with confidence.\nAlign documentation\, processes\, and teams with the updated standard.\nReduce risk and ensure inspection-ready compliance.\nImplement the enhanced risk management processes introduced in ISO 14155:2026.\n\nThis Q&A session complements the training courses by providing an opportunity to discuss specific questions and implementation challenges directly with a leading expert. \nSubmit Your Questions\nParticipants are encouraged to submit their questions in advance to: \nsupport@iceps-mdivd.org \nQuestions received before the session will help shape the discussion and ensure that key implementation challenges and practical concerns are addressed during the live event. \nPractical Information\n\nDate: 9 July 2026\nTime: 14:00–15:30 CET\nDuration: 1 hour 30 minutes\nFormat: Online via Zoom\nRegistration Fee: €15 per participant\nFree Access: Participants who have completed one of the WMDO ISO 14155:2026 training courses may attend free of charge.\nZoom Access: The Zoom link and connection details will be sent by email to all participants one day before the event.\nRecording: The session will not be recorded.\n\nImportant Information\nPlease note that this event is a live Question & Answer session only. \nThe purpose of the session is to provide clarification and discussion on the implementation of ISO 14155:2026 and its risk management requirements. Participants 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.
URL:https://iceps-mdivd.org/event/iso-141552026-risk-management-for-clinical-investigations/
LOCATION:Zoom  Webinar
ATTACH;FMTTYPE=image/png:https://iceps-mdivd.org/wp-content/uploads/2026/06/ISO-141552026-Risk-Management-for-Clinical-Investigations.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Brussels:20260611T140000
DTEND;TZID=Europe/Brussels:20260611T150000
DTSTAMP:20260602T145833Z
CREATED:20260602T145833Z
LAST-MODIFIED:20260602T145833Z
UID:10000002-1781186400-1781190000@iceps-mdivd.org
SUMMARY:ICEPS Launch Webinar 2026 – Discover the International Clinical Evidence Professional Society
DESCRIPTION:Date : 11 June 2026 | Time : 14:00 CET\nFormat : Online Webinar | Free Registration \nJoin us for the official launch of the International Clinical Evidence Professional Society (ICEPS)\, a new international association dedicated to bringing together professionals involved in clinical evidence generation\, communication\, and strategic use of evidence across healthcare and life sciences. \nThis introductory webinar marks the beginning of an exciting journey. During this session\, you will discover the vision behind ICEPS\, meet the members of the Board\, and learn how the association aims to create a vibrant professional community that fosters collaboration\, knowledge sharing\, professional development\, and innovation. \nWe will also present the key initiatives planned for 2026\, including: \n\nEducational webinars and expert-led sessions\nScientific and professional publications\nNetworking and community-building activities\nThe ICEPS Annual Conference scheduled for November 2026\nOpportunities for members to contribute and shape the future of the association\n\nWhether you are a medical writer\, evidence generation specialist\, HEOR professional\, market access expert\, publication manager\, or any professional involved in clinical evidence\, this webinar is an opportunity to learn more about ICEPS and become part of a growing international community. \nWe look forward to welcoming you to this inaugural event and sharing our vision for the future of clinical evidence professionals worldwide. \nRegistration is free but required. Reserve your place today and join us for the official launch of ICEPS.
URL:https://iceps-mdivd.org/event/iceps-launch-webinar-2026-discover-the-international-clinical-evidence-professional-society/
LOCATION:Zoom  Webinar
ATTACH;FMTTYPE=image/png:https://iceps-mdivd.org/wp-content/uploads/2026/06/Version-plus-corporate-de-Mon-travail.png
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