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DTSTART;TZID=Europe/Brussels:20260910T140000
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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
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DTSTART;VALUE=DATE:20261104
DTEND;VALUE=DATE:20261106
DTSTAMP:20260727T085811Z
CREATED:20260611T103407Z
LAST-MODIFIED:20260727T085811Z
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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
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