BEGIN:VCALENDAR VERSION:2.0 METHOD:PUBLISH PRODID:-//Telerik Inc.//Sitefinity CMS 15.4//EN BEGIN:VTIMEZONE TZID:UTC BEGIN:STANDARD DTSTART;VALUE=DATE:20250101 TZNAME:UTC TZOFFSETFROM:+0000 TZOFFSETTO:+0000 END:STANDARD END:VTIMEZONE BEGIN:VEVENT DESCRIPTION:Date: Tuesday 21st April \;2026\nTime: \;14:00 - 15:30 (GMT) / 15:00 - 16:30 (CET)\nLocation: \;Online via Zoom\nSpeakers:&nb sp\;Vivian Lanius (UCB)\, Francesca Callegari (Novartis) and Maarten van D ijk (Staburo GmbH) \;\n\nWho is this event intended for?:\nClinical re searchers\, medical writers\, statisticians\, and anyone engaged in report ing clinical trial results.\n\nWhat is the benefit of attending?:\nKey tak eaways will be:\n- Why estimands matter for decision-making and communicat ion.\n- Practical considerations for integrating estimands into study repo rts.\n- Lessons learned from case studies and real-world applications.\nCo st\nThis webinar is free to both Members of PSI and Non-Members.\nRegistra tion\nTo register for this event\, please click here\nOverview\nClear and transparent reporting of clinical trial results is essential for regulator y decision-making\, scientific evaluation\, and effective communication wi th healthcare professionals and patients. With the introduction of the ICH E9(R1) addendum on estimands and sensitivity analysis\, the industry has a powerful framework to improve clarity around treatment effects. But how can this framework be effectively implemented in practice at the stage of reporting study results?\n\nJoin us for an insightful webinar where we exp lore practical strategies for applying the estimand framework in clinical study reporting. Drawing on real-world experiences and case studies\, we w ill share recommendations to help you:\n- Understand the role of estimands in improving transparency and interpretation of trial results.\n- Navigat e common challenges in implementing the framework during reporting.\n- App ly best practices to enhance regulatory submissions\, webposting in public registries (clinicaltrials.gov/CTIS)\, and scientific publications.\n\nWh ether you are involved in clinical trial design\, data analysis\, or regul atory submissions\, this session will provide actionable guidance to reali ze the full potential of the estimand framework.\n\nSpeakers\n\n \n \n Speaker\n  \;Biography\n \n \n  \;\n Vivian Lanius (UCB)\n Vivia n is a Statistical Methodology Lead in UCB&rsquo\;s Statistical Innovation group\, a role she assumed in 2024 after more than 18 years as a statisti cian at Bayer. She serves as a EFSPI Council Member for the German member group APF and is Chair of the EFSPI Regulatory Statistics Workshop for 202 5 and 2026. Vivian is also an active member of the EFSPI/EFPIA Estimand Im plementation Working Group (EIWG)\, where she leads the reporting subteam. \n \n \n  \;\n Francesca Callegari (Novartis)\n Francesca is as a Director of Biostatistics at No vartis. She began her career in 2003 as a biostatistician at Bristol Myers Squibb and has since accumulated over twenty years of experience at Novar tis across multiple therapeutic areas. She is an active contributor to the Novartis Estimand Implementation Team as well as the EFSPI/EFPIA Estimand Implementation Working Group\, with a particular focus on the reporting s ubteam.\n \n \n  \;\n Maarten van Dijk (Staburo GmbH) \;\n Maarten is an associate director i n the Data Transparency &\; Medical Writing group at Staburo GmbH\, bef ore moving to industry more than six years ago he worked as a researcher i n academia. He is currently working to implement Estimands in clinical res earch both at Staburo GmbH and as part of the EFSPI/EFPIA Estimand Impleme ntation Working Group (EIWG)\, reporting subteam. \;\n \n \n \n DTEND:20260421T153000Z DTSTAMP:20260418T191346Z DTSTART:20260421T140000Z LOCATION: SEQUENCE:0 SUMMARY:Enhancing Clinical Study Reporting with the Estimand Framework UID:RFCALITEM639121364269798742 X-ALT-DESC;FMTTYPE=text/html:Date: Tuesday 21st April  \;2026
\nTime: \;14:00 - 15:30 (GMT) / 15:00 - 1 6:30 (CET)
\nLocation: \;Online via Zoom
\n Speakers: \;Vivian Lanius (UCB)\, France sca Callegari (Novartis) and Maarten van Dijk (Staburo GmbH) \;\n
\nWho is this event intended for?:
\nCli nical researchers\, medical writers\, statisticians\, and anyone engaged i n reporting clinical trial results.
\n
\nWhat is the benefit of attending?:
\nKey takeaways will be :
\n- Why estimands matter for decision-making and communication.
\n- Practical considerations for integrating estimands into study report s.
\n- Lessons learned from case studies and real-world applications.
\n

Cost

\n

This webinar is free to both Members of PSI and Non-Members.

\n

Registration

\n

To register for this event\, p lease click here

\n

Overview

\n

Clear and transp arent reporting of clinical trial results is essential for regulatory deci sion-making\, scientific evaluation\, and effective communication with hea lthcare professionals and patients. With the introduction of the ICH E9(R1 ) addendum on estimands and sensitivity analysis\, the industry has a powe rful framework to improve clarity around treatment effects. But how can th is framework be effectively implemented in practice at the stage of report ing study results?
\n
\nJoin us for an insightful webinar where we explore practical strategies for applying the estimand framework in cli nical study reporting. Drawing on real-world experiences and case studies\ , we will share recommendations to help you:
\n- Understand the role of estimands in improving transparency and interpretation of trial results .
\n- Navigate common challenges in implementing the framework during reporting.
\n- Apply best practices to enhance regulatory submission s\, webposting in public registries (clinicaltrials.gov/CTIS)\, and scient ific publications.
\n
\nWhether you are involved in clinical tri al design\, data analysis\, or regulatory submissions\, this session will provide actionable guidance to realize the full potential of the estimand framework.
\n
\nSpeakers

\n\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n
Speaker \;Biography
 \;Vivian Lanius
\n Vivian Lanius (UCB)		Vivian is a Statistical Methodology Lead in UCB&rsquo\;s Statisti cal Innovation group\, a role she assumed in 2024 after more than 18 years as a statistician at Bayer. She serves as a EFSPI Council Member for the German member group APF and is Chair of the EFSPI Regulatory Statistics Wo rkshop for 2025 and 2026. Vivian is also an active member of the EFSPI/EFP IA Estimand Implementation Working Group (EIWG)\, where she leads the repo rting subteam.
 \;< img src="https://www.psiweb.org/images/default-source/default-album/france sca.tmb-thumbnail.jpg?Culture=en&\;sfvrsn=402caedb_1&\;sf_site_temp= true&\;sf_site=00000000-0000-0000-0000-000000000000" data-displaymode=" Thumbnail" alt="Francesca" title="Francesca" />
\n Fra ncesca Callegari (Novartis)		Francesca is as a D irector of Biostatistics at Novartis. She began her career in 2003 as a bi ostatistician at Bristol Myers Squibb and has since accumulated over twent y years of experience at Novartis across multiple therapeutic areas. She i s an active contributor to the Novartis Estimand Implementation Team as we ll as the EFSPI/EFPIA Estimand Implementation Working Group\, with a parti cular focus on the reporting subteam.
 \;Maarten
\n Maarten van Dijk (Staburo GmbH) \;		Maarten is an associate director in the Data Transparency &\; Med ical Writing group at Staburo GmbH\, before moving to industry more than s ix years ago he worked as a researcher in academia. He is currently workin g to implement Estimands in clinical research both at Staburo GmbH and as part of the EFSPI/EFPIA Estimand Implementation Working Group (EIWG)\, rep orting subteam. \;
\n
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