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DTSTART;TZID=Europe/Brussels:20261104T140000
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SUMMARY:Post Market Surveys (PMCF/PMPF): Regulatory Framework and Best Practices
DESCRIPTION:Webinar | 4 November 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: 4 November 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/post-market-surveys-pmcf-pmpf-regulatory-framework-and-best-practices/
LOCATION:Zoom  Webinar
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DTSTART;TZID=Europe/Brussels:20261117T140000
DTEND;TZID=Europe/Brussels:20261117T153000
DTSTAMP:20261008T123715Z
CREATED:20261006T074236Z
LAST-MODIFIED:20261008T123715Z
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SUMMARY:Clinical Evidence for Breakthrough designation in Europe
DESCRIPTION:Webinar | 17 November 2026 | 2:00 PM CET \nAbout the Webinar\nThe pathway for breakthrough medical devices in Europe creates new opportunities for innovative technologies addressing unmet clinical needs — but it also raises an important question: how much clinical evidence is enough? \nThis webinar will explore the clinical evidence expectations for breakthrough devices in the context of MDCG 2025-9\, with a particular focus on demonstrating safety and clinical performance while managing residual uncertainties through continuous post-market clinical evidence generation. ICEPS_BtX \nParticipants will gain practical insights into how to determine and justify an appropriate level of clinical evidence when preparing for the CE-marking process. \nWhat Will Be Discussed?\nThe session will address key considerations including: \n\nDefining sufficient clinical evidence for breakthrough devices\nPre-market versus post-market evidence requirements\nClinical investigation design and appropriate endpoints\nContinuous clinical evidence generation through PMCF\nThe role of expert panels and early clinical dialogue ICEPS_BtX\n\nThe webinar will combine expert perspectives with a dedicated Q&A session\, giving participants the opportunity to discuss practical questions and challenges. \nSPEAKER\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. \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. \nDr Langhit Kurar\nGlobal Orthopaedic SME (Subject Matter Expert) \nDr Langhit Kurar is a UK-trained orthopaedic surgeon and Clinical Reviewer at TÜV SÜD\, specialising in the clinical evaluation of medical devices under the EU MDR. He leads the clinical component of TÜV SÜD’s internal Breakthrough Device (BtX) programme and has particular expertise in high-risk and implantable medical devices. He is also lead author of TÜV SÜD’s recent white paper on the EU Breakthrough Device pathway. \nWho Should Attend?\nThis webinar is particularly relevant for clinical and regulatory affairs professionals working with innovative medical devices and IVD technologies\, whether in start-ups\, SMEs or larger organisations. ICEPS_BtX \nWhat Will You Take Away?\nBy the end of the session\, participants will have a clearer understanding of how to approach and justify sufficient clinical evidence for breakthrough devices\, as well as how continuous evidence generation can support the device during the post-market phase. ICEPS_BtX \nPractical Information\n\nDate: 17 November 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 registration 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\nHave questions about clinical evidence for breakthrough devices?\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  \nJoin our experts on 17 November and gain practical insights into navigating clinical evidence requirements for breakthrough designation in Europe. \n 
URL:https://iceps-mdivd.org/event/clinical-evidence-for-breakthrough-designation-in-europe/
LOCATION:Zoom  Webinar
ATTACH;FMTTYPE=image/png:https://iceps-mdivd.org/wp-content/uploads/2026/10/VISUAL1.png
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BEGIN:VEVENT
DTSTART;VALUE=DATE:20270310
DTEND;VALUE=DATE:20270312
DTSTAMP:20260930T092903Z
CREATED:20260611T103407Z
LAST-MODIFIED:20260930T092903Z
UID:10000003-1804636800-1804809599@iceps-mdivd.org
SUMMARY:ICEPS 2027 Conference
DESCRIPTION:Creating Value Across the Medical Device Lifecycle\nJoin us on 10th and 11th of March 2027 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 now \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. \nFooter Simple \n \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-2027-Conference-Wordpress-visual-1.png
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