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: \;Thursday 30th March 2023\nTime: \;14:00-15:30 B ST \;| \;15:00-16:30 CEST \;| \;09:00-10:30 EST\nSpeakers:  \;Judith Anzures-Cabrera \;(Roche)\, Nikhil Kamath \;(Roche)\ , \;Sue McKendrick \;(PPD)\, Antonia Morga \;(Astellas)\, and David Wright \;(AstraZeneca). \;\n\nWho is this event intended for ? \;Clinicians\, Regulators\, Investigators\, Academics\, members of E thics Committees\, Statisticians and health technology assessors.\nWhat is the benefit of attending? \;Attendees will have the opportunity to he ar the perspectives of a variety of stakeholders in determining estimands\ , in turn understanding more about challenges and possible solutions when applying the framework to a challenging realistic setting.\nRegistration\n Registration for this webinar is free to both Members of PSI and Non-Membe rs.\nPlease click here \;to register.\nOverview\nThis is the fourth in the series* of webinars from The Estimands Academy for Trial Teams. We wi ll build on the concepts and case studies previously discussed\, recognizi ng the benefits of following the estimand framework (ICH E9 (R1)). A case study in heart failure will be presented from the perspective of multiple stakeholders. Topics covered will include constructing estimands for diffe rent stakeholder questions of interest including how to develop transparen t estimands for product labels.\n\nThe target outcomes are as follows:\n&b ull\; To apply the estimand framework to a challenging realistic setting\n &bull\; To appreciate the different stakeholder views when determining est imands\n&bull\; To understand the relative merits of different strategies for intercurrent events\n&bull\; Understanding implementation challenges a nd possible solutions\n\nTo view the flyer for this event\, please click h ere.\nSpeaker Details\n\n\n\n \n \n \n Spe aker\n \n \n Biography\n \n \n \n \n \n Judith Anzures-Ca brera\n \n \n Judith Anzures-Cabrera is a data scientist at Roche. She is part of the Estimands Implementation Work ing Group where she leads the Training sub-team.\n \n \n \n \n \n Nikhil Kamath\n \n \n Nikhil Kamath is Group Medical Director and Global Development Leader within Global Product Development Immunology\, Infectious Disease\, and Ophthalmology at Roche.\n \n \n \n \n \n Antonia Morga\n \n \n Antonia Morga is a Global Health Economics and Outcome Research Director. She co-leads the EIWG team on HTAs and RWE studies and is part of EFPIA HTA Working Group.\n \n \n \n \n \n David Wright\n \n \n David Wright is Head of Statistical Innovatio n at AstraZeneca\, previously worked for the MHRA and led the revision of the CHMP guideline on missing data in confirmatory clinical trials.\n \n \n \n \n \n Sue M cKendrick\n \n \n Sue McKendrick is a Sta tistical Science Director leading the cross-functional Estimand Working Gr oup at PPD and is also a member of the EIWG training subteam.\n \n \n \n\n \; DTEND:20230330T143000Z DTSTAMP:20260721T170939Z DTSTART:20230330T130000Z LOCATION: SEQUENCE:0 SUMMARY:PSI EIWG Webinar: Proposing Estimands from Different Perspectives UID:RFCALITEM639202505799022994 X-ALT-DESC;FMTTYPE=text/html:Date: \;Thursday 30th Mar ch 2023
\nTime: \;14:00-15:30 BST \;| \;15:00-16:30 CEST \;| \;09:00-10:30 EST
\nSpeakers:< /strong> \;Judith Anzures-Cabrera \;(Roche)\, Nikhil Kama th \;(Roche)\, \;Sue McKendrick \;(PPD)\, An tonia Morga \;(Astellas)\, and David Wright \;(AstraZ eneca). \;
\n
\nWho is this event intended for?  \;Clinicians\, Regulators\, Investigators\, Academics\, memb ers of Ethics Committees\, Statisticians and health technology assessors.< br />\nWhat is the benefit of attending? \;Attendees will have the opportunity to hear the perspectives of a variety of stakeho lders in determining estimands\, in turn understanding more about challeng es and possible solutions when applying the framework to a challenging rea listic setting.
\n

Registration

\n

Registration for this web inar is free to both Members of PSI and Non-Members.
\nPlease click here< /a> \;to register.

\n

Overview

\n

This is the fourth in th e series* of webinars from The Estimands Academy for Trial Teams. We will build on the concepts and case studies previously discussed\, recognizing the benefits of following the estimand framework (ICH E9 (R1)). A case stu dy in heart failure will be presented from the perspective of multiple sta keholders. Topics covered will include constructing estimands for differen t stakeholder questions of interest including how to develop transparent e stimands for product labels.
\n
\nThe target outcomes are as follows:
\n&bull\; To apply the estimand framework to a challenging realistic setting
\n&bu ll\; To appreciate the different stakeholder views when determining estima nds
\n&bull\; To understand the relative merits of different strategi es for intercurrent events
\n&bull\; Understanding implementation cha llenges and possible solutions
\n
\nTo view the flyer for this e vent\, please click here.

\n

Speaker Details

\n\n
\n\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n

Antoniaedited
\n Antonia Morga

\n \n \n \n \n \n \n \n \n \n \n \n
\n

Speaker

\n 		\n

Biography< /p>\n

\n

Judithedited
\n Judith Anzures-Cabrera

\n 		\n

Ju dith Anzures-Cabrera is a data scientist at Roche. She is part of the Esti mands Implementation Working Group where she leads the Training sub-team.< /p>\n

\n

Nikhiledited
\n Nikhil Kamath

\n 		\n

Nikhil Kama th is Group Medical Director and Global Development Leader within Global P roduct Development Immunology\, Infectious Disease\, and Ophthalmology at Roche.

\n
\n

A ntonia Morga is a Global Health Economics and Outcome Research Director. S he co-leads the EIWG team on HTAs and RWE studies and is part of EFPIA HTA Working Group.

\n
\n

Davidedited
\n David Wright

\n < /td>\n 		\n

David Wright is Head of Statistical Innovation at AstraZeneca\, previousl y worked for the MHRA and led the revision of the CHMP guideline on missin g data in confirmatory clinical trials.

\n
\n

Sueedited
\n Sue McKendrick

\n 		\n

Sue McKendrick is a Statistical Science Director lead ing the cross-functional Estimand Working Group at PPD and is also a membe r of the EIWG training subteam.

\n
\n \;
END:VEVENT END:VCALENDAR