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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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