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:Estimands Implementation Working Group &ndash\; Training Subtea m in Collaboration with PHUSEDate: Tuesday 29 September 2026Time: \;14 :00 - 15:30 BSTLocation: \;Online via ZoomWho is this event intended f or?This webinar is aimed primarily at statistical programmers\, with usefu l insights for data managers\, statisticians\, medical writers\, clinician s and regulators. It will be assumed attendees already have a background u nderstanding of estimands and intercurrent events.What is the benefit of a ttending?Understand the core challenges posed by intercurrent event (ICE) handling strategies to data collection\, analysis\, and documentationIllus trate how to build Analysis Datasets supporting estimators\, including the implementation of the ADICE dataset and tracing impacted datapoints using the ICCyEzz approachRecognize the best practices for end-to-end documenta tion\, specifically how to detail estimand implementations in the Clinical Study Data Reviewer's Guide (cSDRG) and Analysis Data Reviewer's Guide (A DRG)OverviewThe ICH E9(R1) estimand framework has important implications n ot only for trial design and analysis\, but also for data collection\, dat a flow\, and analysis dataset creation. This webinar will focus on impleme ntation of the estimand framework using data standards\, with particular e mphasis on the considerations needed to support estimation of estimands an d traceability of intercurrent events.Building on the PHUSE white paper Im plementation of ICH E9(R1) Estimands Framework using Data Standards​\, the session will discuss practical approaches across the clinical data flow\, from CRFs and SDTM to ADaM and reviewer documentation. Topics will includ e how to capture and map information relevant to intercurrent events\, con siderations for ADaM datasets including ADICE\, and approaches to document ing estimand implementation clearly and consistently. A case study will il lustrate how these principles can be applied in practice.RegistrationThis webinar is free to attend for PSI Members &\; Non-Members.To register f or this event\, please \;click here.Speaker details\n.table img {\n width: 150px\;\n height: 225px\;\n object-fit: cover\;\n }\n\n\nSp eakerBiographyShahida Tamboli\, Sr. Manager\, Biostatistics - \;Fortre aSenior Manager of Biostatistics at Fortrea.  \;PHUSE working group co ‑lead for ICH E9(R1) estimands. Expertise includes imputation methods\, se nsitivity analyses\, and advanced statistical methodologies. Elisa Gomez V alderas\, Director\, Eli LillyDirector in Statistics at Eli Lilly\, with e xpertise in innovative clinical trial design\, clinical development and ac cess-focused research. She is a co-author of the PHUSE white paper on impl ementing estimands in industry standards.\n Alexandra Cochinaire\,& nbsp\;Standard Implementation Lead\, \;Johnson &\; JohnsonStandards Implementation Lead at Johnson &\; Johnson with experience in statisti cs\, programming\, clinical data standards\, and estimands\, helping study teams achieve high-quality and consistent standards implementation from p rotocol development through analysis.Xiaohan Zou\, \;Director\, Statis tical Programming\, BMSDirector in Statistical Programming at Bristol Myer s Squibb. She is a co-author of the PHUSE white paper on implementing esti mands in industry standards DTEND:20260929T153000Z DTSTAMP:20260812T150927Z DTSTART:20260929T140000Z LOCATION: SEQUENCE:0 SUMMARY:Making Estimands Work - Practical Approaches with Implementation in Data Standards UID:RFCALITEM639221441671910055 X-ALT-DESC;FMTTYPE=text/html:

Estimands Implementation Working Gr oup &ndash\; Training Subteam in Collaboration with PHUSE

< strong>Date: Tuesday 29 September 2026
Time: \;14:00 - 15:30 BST
Location: \;Online via Zoom

Who is this event intended for?

This webinar is aimed primarily at statistical programmers \, with useful insights for data managers\, statisticians\, medical writer s\, clinicians and regulators. It will be assumed attendees already have a background understanding of estimands and intercurrent events.

< p>What is the benefit of attending?

Overview

The ICH E9(R1) estimand framework h as important implications not only for trial design and analysis\, but als o for data collection\, data flow\, and analysis dataset creation. This we binar will focus on implementation of the estimand framework using data st andards\, with particular emphasis on the considerations needed to support estimation of estimands and traceability of intercurrent events.

Building on the PHUSE white paper Implementation of ICH E9(R1 ) Estimands Framework using Data Standards​\, the session will discuss practical approaches across the clinical data flow\, from CRFs and SDTM t o ADaM and reviewer documentation. Topics will include how to capture and map information relevant to intercurrent events\, considerations for ADaM datasets including ADICE\, and approaches to documenting estimand implemen tation clearly and consistently. A case study will illustrate how these pr inciples can be applied in practice.

Registration

This webinar is free to attend for PSI Members &\; Non-Members.
To register for this ev ent\, please \;cli ck here.

Speaker details

\n\n\n
SpeakerBiography

Shahida Tamboli\, S r. Manager\, Biostatistics - \;Fortrea

Senior Manager of Biostatistics at Fortrea.  \;PHUSE workin g group co‑lead for ICH E9(R1) estimands. Expertise includes imputation me thods\, sensitivity analyses\, and advanced statistical methodologies.

Elisa Gomez Valderas\, Director\, Eli Lilly

Director in Stati stics at Eli Lilly\, with expertise in innovative clinical trial design\, clinical development and access-focused research. She is a co-author of th e PHUSE white paper on implementing estimands in industry standards.\n

Alexandra Cochinaire\, \;Standard Implementation Lead\, \;Johnson &\; Johnson

Standards Implementation Lead at Jo hnson &\; Johnson with experience in statistics\, programming\, clinica l data standards\, and estimands\, helping study teams achieve high-qualit y and consistent standards implementation from protocol development throug h analysis.


Xiaohan Zou\,  \;Director\, Statistical Programming\, BMS

Director in Statistical Programming at Bristol Myers Sq uibb. She is a co-author of the PHUSE white paper on implementing estimand s in industry standards

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