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DTSTART;TZID=Europe/Brussels:20261008T140000
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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: €15 for ICEPS members and 35€ 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 live Question & Answer session only. \nThe purpose of the session is to provide clarification and discussion on the implementation of Estimands. 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. \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. \nRegister now and join us to better understand the EU JCA landscape and prepare for what comes next.
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:20261022T140000
DTEND;TZID=Europe/Brussels:20261022T173000
DTSTAMP:20260915T074849Z
CREATED:20260915T074849Z
LAST-MODIFIED:20260915T074849Z
UID:10000014-1792677600-1792690200@iceps-mdivd.org
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 30 September 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 \n  \nPractical Information\n\nDate: 22 October 2026\nTime: 2:00 PM CET\nFormat: Online via Zoom\nRegistration Fee: €15 for ICEPS members and 35€ 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 live Question & Answer session only. \nThe purpose of the session is to provide clarification and discussion on the implementation of Estimands. 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. \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.
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
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BEGIN:VEVENT
DTSTART;TZID=Europe/Brussels:20261029T143000
DTEND;TZID=Europe/Brussels:20261029T153000
DTSTAMP:20260828T132226Z
CREATED:20260821T102058Z
LAST-MODIFIED:20260828T132226Z
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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. \n  \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: €15 for ICEPS members and 35€ 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 live Question & Answer session only. \nThe purpose of the session is to provide clarification and discussion on the implementation of Estimands. 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. \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.
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
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20261104
DTEND;VALUE=DATE:20261106
DTSTAMP:20260727T085811Z
CREATED:20260611T103407Z
LAST-MODIFIED:20260727T085811Z
UID:10000003-1793750400-1793923199@iceps-mdivd.org
SUMMARY:ICEPS 2026 Conference
DESCRIPTION:Creating Value Across the Medical Device Lifecycle\nJoin us on 4–5 November 2026 for the iCEPS Medical Devices & IVD Conference\, a hybrid event bringing together experts\, industry leaders\, regulators\, HTA specialists\, HEOR professionals\, and innovators from across the medical device ecosystem. \nConference Theme\nCreating Value Across the Medical Device Lifecycle \nThis year’s theme highlights value creation at every stage of the medical device lifecycle\, from innovation and development to market access\, reimbursement\, patient access\, and real-world outcomes. The programme will integrate key perspectives including Health Technology Assessment (HTA) and Health Economics and Outcomes Research (HEOR). \nEvent Format\nThe conference will be held in a hybrid format\, allowing participants to attend either in person or online. \n\nIn-person participants will have access to all conference sessions\, workshops\, and roundtable discussions.\nOnline participants will have access to the main conference sessions but will not have access to workshops and roundtable discussions.\n\nThe Zoom access link for virtual attendees will be sent a few days before the event. \nVenue\nSilversquare Bailli\nAvenue Louise 251\n1050 Brussels\, Belgium \nRegistration\nRegistration opens on 11 June 2026. \nPlease note that the number of places is limited\, and registrations will be processed on a first-come\, first-served basis. \nRegistration Fees\n\nIn-person attendance: €500 (excluding VAT) for ICEPs members and €700 non-members\nOnline attendance: €400 (excluding VAT) for ICEPs members and €600 non-members\n\nProgramme\nThe detailed conference programme will be announced at a later date. \nCall for Speakers\nInterested in speaking at the conference? \nWe welcome submissions from professionals\, researchers\, industry experts\, and stakeholders across the medical device sector. To apply as a speaker\, please submit your proposal through the following form: \nhttps://docs.google.com/forms/d/e/1FAIpQLSfXa77EW0a6UqayrWMUNrD4CKa91A8nXZFmsM45ypuk1VuhoA/viewform \nSponsorship Opportunities\nOrganizations interested in sponsoring or collaborating with the conference are invited to contact us at: \nsupport@iceps-mdivd.org \nWe look forward to welcoming you to Brussels for two days of discussion\, learning\, and networking dedicated to creating value across the medical device lifecycle.
URL:https://iceps-mdivd.org/event/iceps-2026-conference/
LOCATION:Silversquare Bailli\, Avenue Louise 251\, Brussels\, 1050\, Belgium
ATTACH;FMTTYPE=image/png:https://iceps-mdivd.org/wp-content/uploads/2026/06/ICEPS-2026-Conference-Wordpress-visual-.png
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