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DTSTART;TZID=Europe/Brussels:20260709T140000
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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
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DTSTART;VALUE=DATE:20261104
DTEND;VALUE=DATE:20261106
DTSTAMP:20260611T103445Z
CREATED:20260611T103407Z
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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)\nOnline attendance: €400\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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