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DTSTART;TZID=Europe/Brussels:20260917T140000
DTEND;TZID=Europe/Brussels:20260917T150000
DTSTAMP:20260821T083858Z
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SUMMARY:Post Market Surveys (PMCF/PMPF): Regulatory Framework and Best Practices
DESCRIPTION:Webinar | 17 September 2026 | 2:00 PM CET \nABOUT THE WEBINAR\nPost-market surveys can be a practical\, proportionate and scientifically robust tool for generating real-world evidence across the product lifecycle. \nThis webinar will explore their application within Post-Market Clinical Follow-up (PMCF) and Post-Market Performance Follow-up (PMPF)\, providing an overview of the current regulatory framework in Europe and other key regions. \nParticipants will learn when surveys are an appropriate post-market activity\, what regulators and notified bodies expect from well-designed survey programmes\, and how survey-based evidence can support safety\, performance\, usability and clinical practice insights. \nDrawing on current best practices and real-world examples\, the webinar will provide practical guidance on designing and implementing post-market surveys that are both regulator-ready and strategically valuable\, demonstrating how high-quality survey data can support evidence needs beyond compliance alone. \nWHAT YOU WILL LEARN\nDuring this webinar\, participants will gain: \n\nAn understanding of the regulatory framework and practical role of post-market surveys in supporting PMCF\, PMPF and wider real-world data collection for medical devices.\nFoundational knowledge for designing scientifically sound and risk-proportionate post-market survey programmes.\nPractical insights into defining clear objectives\, selecting meaningful endpoints\, justifying sample sizes and mitigating potential bias.\nA better understanding of how survey-generated data can provide meaningful evidence on safety\, performance\, usability and clinical practice.\nInsight into how well-designed post-market surveys can support not only regulatory compliance\, but also broader lifecycle and strategic evidence needs.\n\nWHO SHOULD ATTEND?\nThis webinar is particularly relevant for: \n\nClinical evidence professionals and researchers involved in medical device development\nRegulatory affairs professionals\nQuality managers involved in international submissions\nProfessionals working with PMCF and PMPF activities\nRegulatory body representatives\nAcademics and researchers interested in post-market evidence generation\n\nWHY THIS WEBINAR MATTERS\nFor many low- to medium-risk\, mature or well-established devices\, conducting a full clinical investigation may create unnecessary operational burden for healthcare professionals and introduce avoidable ethical and practical challenges when a well-designed post-market survey could provide the required evidence. \nHowever\, surveys are often underused or poorly implemented due to unclear objectives\, weak endpoint selection\, inadequate sample size justification or insufficient control of bias. \nThis webinar addresses these challenges by providing a practical framework for developing post-market surveys that are proportionate\, scientifically robust and capable of generating meaningful real-world data. \nSPEAKER\nMarcus Torr\nHead of Post Market Survey\, Purdie Pascoe \nMarcus Torr joined Purdie Pascoe in 2015 after graduating from the University of Bath with a First Class MSci in Natural Sciences (Chemistry with Pharmacology). After nearly five years within the company’s Primary Market Research team\, he combined his expertise in quantitative research and healthcare insights to establish and lead Purdie Pascoe’s dedicated Post Market Survey team in 2019. \nToday\, Marcus leads a team of more than 15 specialists delivering Post Market Survey solutions to the global medical device industry. His work focuses on supporting regulatory compliance and evidence generation through Post-Market Clinical Follow-up (PMCF)\, Post-Market Performance Follow-up (PMPF)\, and broader real-world data (RWD) collection programmes. \nMarcus has extensive experience in the design\, delivery\, and regulatory application of post-market surveys\, having overseen more than 600 studies for leading medical device manufacturers across a wide range of therapeutic areas and device types. These programmes have been reviewed and accepted by several leading Notified Bodies and encompass both broad end-user surveys (Level 8) and high-quality case-specific surveys (Level 4). His expertise spans survey methodology\, regulatory evidence requirements\, and the practical use of real-world data to demonstrate product safety\, performance\, and clinical benefit in an evolving global regulatory landscape. \nMODERATOR\nMichel LoPresti\nPresident\, GinePro \nWith over 20 years of experience in Japan’s healthcare industry\, Michael LoPresti is a leading expert in clinical and reimbursement evidence generation for medical devices and regenerative medicines in Japan. As President of GinePro LLC (https://www.gineprogo.com)\, and throughout his career\, he has spearheaded more than 400+ reimbursement strategy studies\, including over 50+ focused on medical devices\, and supported multinational companies and startups in navigating Japan’s complex regulatory and market access landscape. His work emphasizes robust HEOR evidence and generation of real-world evidence (RWE) that contributes to optimal regulatory and reimbursement approvals in Japan. \n  \nMichael is also recognized for his contributions to medical writing\, having authored or co-authored numerous peer-reviewed publications\, including key studies on cost-effectiveness and value-based reimbursement for medical devices in Japan – and other related topics such as epidemiology studies\, systematic literature reviews\, the development of treatment burden scales\, and more. \n  \nA passionate advocate for the valued-based assessments of medical devices\, Michael has led teams of professionals in designing and executing HEOR and RWE studies tailored to Japan’s unique healthcare system. He is also a member of the Medical Devices and Diagnostics Special Interest Group of ISPOR and collaborates with other members of that group to advance value-based evidence for medical devices and IVDs. Fluent in Japanese\, Michael bridges cultural and technical divides to drive innovation in clinical evidence generation in Japan. \nPractical Information\n\nDate: 17 September 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/post-market-surveys-pmcf-pmpf-regulatory-framework-and-best-practices/
LOCATION:Zoom  Webinar
ATTACH;FMTTYPE=image/png:https://iceps-mdivd.org/wp-content/uploads/2026/08/260917-Post-Market-Survey-PMCFPMPF-Event-page-.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Brussels:20261008T140000
DTEND;TZID=Europe/Brussels:20261008T153000
DTSTAMP:20260827T153017Z
CREATED:20260827T152615Z
LAST-MODIFIED:20260827T153017Z
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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:20261014T170000
DTEND;TZID=Europe/Brussels:20261014T180000
DTSTAMP:20260902T143631Z
CREATED:20260828T123511Z
LAST-MODIFIED:20260902T143631Z
UID:10000013-1791997200-1792000800@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: €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/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: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
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Brussels:20261029T143000
DTEND;TZID=Europe/Brussels:20261029T153000
DTSTAMP:20260828T132226Z
CREATED:20260821T102058Z
LAST-MODIFIED:20260828T132226Z
UID:10000011-1793284200-1793287800@iceps-mdivd.org
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
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