BEGIN:VCALENDAR
VERSION:2.0
PRODID:-//iceps-mdivd - ECPv6.17.1//NONSGML v1.0//EN
CALSCALE:GREGORIAN
METHOD:PUBLISH
X-ORIGINAL-URL:https://iceps-mdivd.org
X-WR-CALDESC:Events for iceps-mdivd
REFRESH-INTERVAL;VALUE=DURATION:PT1H
X-Robots-Tag:noindex
X-PUBLISHED-TTL:PT1H
BEGIN:VTIMEZONE
TZID:Europe/Brussels
BEGIN:DAYLIGHT
TZOFFSETFROM:+0100
TZOFFSETTO:+0200
TZNAME:CEST
DTSTART:20250330T010000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:+0200
TZOFFSETTO:+0100
TZNAME:CET
DTSTART:20251026T010000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:+0100
TZOFFSETTO:+0200
TZNAME:CEST
DTSTART:20260329T010000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:+0200
TZOFFSETTO:+0100
TZNAME:CET
DTSTART:20261025T010000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:+0100
TZOFFSETTO:+0200
TZNAME:CEST
DTSTART:20270328T010000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:+0200
TZOFFSETTO:+0100
TZNAME:CET
DTSTART:20271031T010000
END:STANDARD
END:VTIMEZONE
BEGIN:VEVENT
DTSTART;TZID=Europe/Brussels:20261014T170000
DTEND;TZID=Europe/Brussels:20261014T183000
DTSTAMP:20261014T115803Z
CREATED:20260828T123511Z
LAST-MODIFIED:20261014T115803Z
UID:10000013-1791997200-1792002600@iceps-mdivd.org
SUMMARY:Clinical Evaluation for AI-Enabled Medical Device
DESCRIPTION:Navigating Clinical Evidence in the Age of AI\nDate: 14 October 2026 | Time: 17:00 CET / 16:00 GMTFormat: Online Webinar \nAI-enabled medical devices are reshaping the way we approach clinical evaluation. \nFrom defining sufficient clinical evidence to addressing bias\, generalisability\, evolving algorithms and real-world performance\, these technologies bring new questions and challenges for medical device professionals. \nJoin ICEPS for an interactive webinar exploring how established clinical evaluation principles can be applied to AI-enabled medical devices — and where new approaches may be needed. \nWith perspectives from across the medical device ecosystem\, the session will combine expert discussion with the opportunity for participants to ask their questions directly to the panel. \nWhat We’ll Discuss\nDuring the webinar\, we’ll explore questions such as: \n\nWhat does sufficient clinical evidence look like for an AI-enabled device?\nHow should bias and generalisability be addressed?\nWhen might a prospective clinical investigation be needed?\nHow should we approach evolving algorithms and real-world performance?\nWhat role should post-market clinical evidence play?\n\nThese topics reflect the main clinical evidence challenges identified for the webinar. \nSpeakers:\nDr. Kimberly Peven\nClinical Lead\, Regulatory and Clinical Evaluation Specialist\, Internal Clinical Scarlet – Scarlet \nKimberly Peven leads the clinical team at Scarlet\, where she works to help bring safe AI medical devices smoothly through the regulatory process and into the hands of patients. With a background as a Registered Nurse and a PhD in Epidemiology\, she has spent much of her career focused on women’s health\, spanning academic research\, policy work\, and healthtech. She cares deeply about ensuring emerging medical technologies are grounded in solid and continued clinical evidence. \nProf. Dr. Stephen Gilber\nProfessor – Technische Universitat Dresden \nProf. Dr. Gilbert worked in senior MedTech and Digital Heath roles for 5 years\, before returning to academia in 2022 in Dresden\, Germany as Europe’s first full Professor of AI Medical Device Regulatory Science. His research goals are the advancement of regulatory science in AI-enabled medical devices. Innovative digital approaches in healthcare must be accompanied by innovative regulatory and oversight approaches to ensure speed to market\, to maximise the access of patients to life saving treatments while at the same ensuring safety. He evaluates existing methods and regulatory frameworks and develops new solutions for the oversight of AI and digital health. \nAnkeet Tanne\nSenior Consultant – Hardian Health \nAnkeet is a medical doctor with previous experience developing machine learning tools for the prediction of neurodegenerative diseases. He is a Senior Consultant at Hardian\, where he leads the Clinical Department and has successfully advised several clients on product strategy\, and clinical strategy for obtaining CE marking and FDA clearances. Hardian’s core focus is advising companies who are developing novel Software and AI medical devices\, to help them enter international markets. \nModarator\nAmie Smirthwaite\n \nAmie Smirthwaite is a clinical and regulatory affairs expert with over 30 years’ postdoctoral experience in medical devices spanning new product development\, quality and regulatory systems\, and clinical evidence. She has been involved in the development of several MDCG and other clinical evaluation guidance documents and has served on numerous advisory board positions\, including CORE-MD\, HEU-EFS\, and NORE\, amongst others. She is an active participant in several ISO committees relating to medical device clinical and technical evidence. She currently works as an independent consultant advising on clinical and regulatory affairs\, but previously worked for BSI\, where she was Global Head of Clinical Compliance. Amie was BSI’s first Head of Clinical Compliance\, building their clinical compliance team and leading the development of their clinical evaluation processes. She also developed extensive training materials while at BSI\, including clinical evaluation\, technical documentation\, risk management\, ISO 13485\, EU MDR\, and biological evaluation. Amie is a Fellow of the Regulatory Affairs Professional Society \nWho Should Attend?\nThis webinar is designed for professionals working across Clinical\, Regulatory\, Quality\, R&D and Medical Affairs\, as well as manufacturers\, CROs and consultants involved in the development or evaluation of AI-enabled medical devices. \nWhether you’re new to AI-enabled devices or already working in the field\, this webinar is an opportunity to hear different perspectives\, explore evolving expectations and bring your own questions to the discussion. \nHave questions about clinical evaluation for AI-enabled medical devices?\nBring them to the webinar and join the conversation. \nPractical Information\n\nDate: 14 October 2026\nTime: 17:00 CET / 16:00 GMT\nDuration: 60 minutes\nFormat: Online via Zoom\nRegistration Fee: Free 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 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/clinical-evaluation-for-ai-enabled-medical-device/
LOCATION:Zoom  Webinar
ATTACH;FMTTYPE=image/jpeg:https://iceps-mdivd.org/wp-content/uploads/2026/08/261014-Clinical-Evaluations-for-AI-driven-Medical-Devices_web.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Brussels:20261008T140000
DTEND;TZID=Europe/Brussels:20261008T153000
DTSTAMP:20261008T123550Z
CREATED:20260827T152615Z
LAST-MODIFIED:20261008T123550Z
UID:10000012-1791468000-1791473400@iceps-mdivd.org
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:20260910T140000
DTEND;TZID=Europe/Brussels:20260910T153000
DTSTAMP:20260821T125336Z
CREATED:20260727T070022Z
LAST-MODIFIED:20260821T125336Z
UID:10000008-1789048800-1789054200@iceps-mdivd.org
SUMMARY:Q&A: Estimands Demystified - Understanding Estimands in Medical Device Clinical Research
DESCRIPTION:Live Q&A Session with Danielle Giroud and Jiří Šilar\nDate: 10 September 2026 | Time: 14:00 CET\nFormat: Online Session (Zoom) \nEstimands have become an increasingly important topic in clinical research\, yet they are often perceived as being complex or reserved for statisticians. In reality\, many clinical research professionals already apply the principles of estimands when designing clinical investigations—they simply may not refer to them by this terminology. \nDuring this live Q&A session\, Danielle Giroud and Jiří Šilar will begin with a concise 15–20 minute introduction to estimands from both the clinical and statistical perspectives. Using practical examples\, they will explain what estimands are\, why they matter\, and how they support the design of robust medical device clinical investigations. \nThe remainder of the session will be dedicated to your questions. Participants are encouraged to ask questions live during the event or to submit them in advance when registering\, allowing the speakers to address the topics that matter most to the audience. \nWhether you are discovering estimands for the first time or looking to deepen your understanding of this evolving concept\, this session will provide practical insights and an open forum to discuss real-world challenges with two experienced experts in the field. \n  \nDanielle Giroud\nFounder\, Chief Executive Officer 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. Ms. Giroud is also known for her contribution and engagement as founder and senior faculty board member of the World Medical Device Organization (WMDO). Since 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. \nJiří Šilar\nBiostatistician at the Institute of Biostatistics and Analyses \nJiří holds a master’s degree in Mathematical Biology and has worked as a Biostatistician at the Institute of Biostatistics and Analyses for the past 11 years. He specializes in the design\, statistical analysis\, and interpretation of clinical trials and research studies across a wide range of therapeutic areas. Alongside his work on clinical projects\, he provides statistical consulting\, supporting clients in addressing complex methodological challenges and developing solutions tailored to their research needs. His expertise spans study design\, sample size determination\, SAS programming\, CDISC-compliant data labelling\, data interpretation\, and the effective communication of statistical findings to clients and project teams. \n  \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: 10 September 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\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/qa-estimands-demystified-understanding-estimands-in-medical-device-clinical-research/
LOCATION:Zoom  Webinar
ATTACH;FMTTYPE=image/png:https://iceps-mdivd.org/wp-content/uploads/2026/07/260910-QA-Estimands-Demystifie_Event-page.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Brussels:20260709T140000
DTEND;TZID=Europe/Brussels:20260709T153000
DTSTAMP:20260611T103533Z
CREATED:20260611T103348Z
LAST-MODIFIED:20260611T103533Z
UID:10000005-1783605600-1783611000@iceps-mdivd.org
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
END:VEVENT
END:VCALENDAR