Date: Tuesday 21st April 2026
Time: 14:00 - 15:30 (GMT) / 15:00 - 16:30 (CET)
Location: Online via Zoom
Speakers: Vivian Lanius (UCB), Francesca Callegari (Novartis) and Maarten van Dijk (Staburo GmbH)
Who is this event intended for?:
Clinical researchers, medical writers, statisticians, and anyone engaged in reporting clinical trial results.
What is the benefit of attending?:
Key takeaways will be:
- Why estimands matter for decision-making and communication.
- Practical considerations for integrating estimands into study reports.
- Lessons learned from case studies and real-world applications.
This webinar is free to both Members of PSI and Non-Members.
To register for this event, please click here
Clear and transparent reporting of clinical trial results is essential for regulatory decision-making, scientific evaluation, and effective communication with 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?
Join us for an insightful webinar where we explore practical strategies for applying the estimand framework in clinical study reporting. Drawing on real-world experiences and case studies, we will share recommendations to help you:
- Understand the role of estimands in improving transparency and interpretation of trial results.
- Navigate common challenges in implementing the framework during reporting.
- Apply best practices to enhance regulatory submissions, webposting in public registries (clinicaltrials.gov/CTIS), and scientific publications.
Whether you are involved in clinical trial design, data analysis, or regulatory submissions, this session will provide actionable guidance to realize the full potential of the estimand framework.
Speakers
| Speaker | Biography |
 Vivian Lanius (UCB) |
Vivian is a Statistical Methodology Lead in UCB’s Statistical 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 Workshop for 2025 and 2026. Vivian is also an active member of the EFSPI/EFPIA Estimand Implementation Working Group (EIWG), where she leads the reporting subteam. |
 Francesca Callegari (Novartis) |
Francesca is as a Director of Biostatistics at Novartis. She began her career in 2003 as a biostatistician at Bristol Myers Squibb and has since accumulated over twenty years of experience at Novartis 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 subteam. |
 Maarten van Dijk (Staburo GmbH) |
Maarten is an associate director in the Data Transparency & Medical Writing group at Staburo GmbH, before moving to industry more than six years ago he worked as a researcher in academia. He is currently working to implement Estimands in clinical research both at Staburo GmbH and as part of the EFSPI/EFPIA Estimand Implementation Working Group (EIWG), reporting subteam. |
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