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 12th January 2021\nTime: Tues. 12th - 15:00-16:30 GMT\nSpeakers: Melanie Wright \;(Novartis)\, \;Sue McKendrick&nbs p\;(PPD)\, \;Nanco Hefting \;(Lundbeck)\, Rikke Mette Agesen \ ;(NovoNordisk)\, and Helle Lynggaard \;(NovoNordisk).\n\nWho is this e vent intended for? \;Anyone working in clinical trials: Clinician\, Re gulator\, Investigator\, Academic\, Ethics Committee\, Statistician.\nWhat is the benefit of attending? \;Understand how to describe clinical ob jectives using the estimands framework\, recognising the benefits of this approach.\nRegistration\nYou can now register for this event. \nThis event is \;free of charge \;to both Members and Non Members of PSI.\nPl ease note: this event takes place on both the 12th &\; 19th January\, b ut will entail exactly the same content. \;\n\nTo register for the 12t h January session\, please click here.\nTo register for the 19th January s ession\, please click here.\nOverview\nBringing estimands to life through a real case study. A year on after the final ICH E9 estimands addendum was published\, we \;bring estimands to life from a real example from pro tocol to press release. Members of the estimands Implementation Working Gr oup (EIWG) will describe the background and study objectives\, intercurren t events of interest and chosen estimands in the PIONEER study. \;\nSp eaker Details\n\n\n\n \n \n \n Speaker\n \n \n Biography\n \n \n \n \n \n \n \n \n \n \n \n \n \ n Melanie Wright\n Novartis\n \n \n Melanie Wright is a Biostatistics Global Group Head at No vartis Pharma AG. She has an MSc in Biometry from University of Reading (U K) and started working in the pharmaceutical industry in 1996. Despite her background in statistics\, Melanie describes herself as &ldquo\;an experi enced drug developer with a focus on structured quantitative decision maki ng&rdquo\;. Melanie has been leading many activities as part of the estima nd workstream at Novartis for the last 3 years and from last year became i nvolved in the EFSPI/EFPIA estimand working group.\n \n \n \n \n \n \n \n \n \n \n \n \n \n Sue McKendrick\n PPD\n \n \n Sue McKendrick is an Associate Statistical Science Director leading the cross-functional Estimand Working Group at PPD. In 1991\, she graduated with an M.Sc. in Biometry from University of Reading\, UK and h as been a Chartered Statistician since 1998. Sue has over 25 years&rsquo\; experience of statistical consultancy across drug development in both CRO and pharma companies\, including collaborating with clinical colleagues o n protocol development.\n \n \n \n \n \n \n \n \n \n \n \n \n \n Nanco Hefti ng\n Lundbeck\n \n \n Nanco He fting is Chief Scientific Specialist in the Clinical Research &ndash\; Psy chiatry department at H. Lundbeck A/S\, Copenhagen\, Denmark. He has a Mas ter of Science in pharmacy and pharmacist education from the University of Groningen\, NL\, 1991 and has worked since as a clinical scientist and cl inical lead in Clinical Pharmacology and Clinical Development in various c ompanies. Nanco has been involved in the EFSPI/EFPIA estimand working grou p and is Co-Chair of the EIWG.\n \n \n \n \n \n \n \n \n \n \n \n \n \n Rikk e Agesen\n Novo Nordisk\n \n \n Rikke Mette Agesen is a Senior International Medical Manager in Global D evelopment at Novo Nordisk. She graduated as a Medical Doctor in 2010 from the University of Copenhagen and has several years of clinical experience within Internal Medicine and Endocrinology. Rikke holds a PhD and a Postd octoral position in Type 1 diabetes and hypoglycaemia. With a physician&rs quo\;s perspective Rikke represents Novo Nordisk in the EFPIA/EFSPI estima nd implementation working group (EIWG).\n \n \n \ n \n \n \n \n \n \n \n \n \n \n \n Helle Lynggaard\n Novo Nordisk\n \n \n Helle Lynggaard is a Principal Statistician in Global Development at Novo Nordisk. She obtained her MSc from the Univers ity of Aalborg in 1994 and her PhD in 2005 from the University of Copenhag en. She has worked with Novo Nordisk since 1994 in different statistical r oles including being a Project Statistician. Since 2015 she has been worki ng in a cross-project biostatistics department that provides support to st atisticians in the clinical projects. Helle is a key driver in implementin g estimands in Novo Nordisk studies\, and is a member of the EFPIA/EFSPI e stimand implementation working group (EIWG).\n \n \n \n\n \; DTEND:20210112T163000Z DTSTAMP:20260910T220722Z DTSTART:20210112T150000Z LOCATION: SEQUENCE:0 SUMMARY:PSI EIWG Webinar: PIONEERing estimands in Clinical Research (Sessio n 1) UID:RFCALITEM639246748422164953 X-ALT-DESC;FMTTYPE=text/html:Date: Tuesday 12th January 20 21
\nTime: Tues. 12th - 15:00-16:30 GMT
\nSpeakers: Melanie Wright \;(Novartis)\, \;Sue McKendrick \;(PPD)\, \;Nanco Hefting \;(Lundbeck )\, Rikke Mette Agesen \;(NovoNordisk)\, and Helle Lyngg aard \;(NovoNordisk).
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\nWho is this even t intended for? \;Anyone working in clinical trials: Clinicia n\, Regulator\, Investigator\, Academic\, Ethics Committee\, Statistician.
\nWhat is the benefit of attending? \;Understan d how to describe clinical objectives using the estimands framework\, reco gnising the benefits of this approach.
\n

Registration

\n

Yo u can now register for this event.
\nThis event is \;free of cha rge \;to both Members and Non Members of PSI.
\nPlease no te: this event takes place on both the 12th &\; 19th January\, but will entail exactly the same content. \;
\n
\nTo regist er for the 12th January session\, please click here.
\nTo register for the 19th January session\, please click here.

\n

Overview

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B ringing estimands to life through a real case study. A year on after the f inal ICH E9 estimands addendum was published\, we \;bring estimands to life from a real example from protocol to press release. Members of the e stimands Implementation Working Group (EIWG) will describe the background and study objectives\, intercurrent events of interest and chosen estimand s in the PIONEER study. \;

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Speaker Details

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Helle Lynggaard is a Principal Statistician in Global Development at Novo Nordisk. She obtai ned her MSc from the University of Aalborg in 1994 and her PhD in 2005 fro m the University of Copenhagen. She has worked with Novo Nordisk since 199 4 in different statistical roles including being a Project Statistician. S ince 2015 she has been working in a cross-project biostatistics department that provides support to statisticians in the clinical projects. Helle is a key driver in implementing estimands in Novo Nordisk studies\, and is a member of the EFPIA/EFSPI estimand implementation working group (EIWG).\n \n

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Speaker

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Biography

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\n Melanie Wright
\n Novartis

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Melanie Wright is a Biostatis tics Global Group Head at Novartis Pharma AG. She has an MSc in Biometry f rom University of Reading (UK) and started working in the pharmaceutical i ndustry in 1996. Despite her background in statistics\, Melanie describes herself as &ldquo\;an experienced drug developer with a focus on structure d quantitative decision making&rdquo\;. Melanie has been leading many acti vities as part of the estimand workstream at Novartis for the last 3 years and from last year became involved in the EFSPI/EFPIA estimand working gr oup.

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\n Sue McKendrick
\n PPD

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Sue McKendrick is an Associate Statis tical Science Director leading the cross-functional Estimand Working Group at PPD. In 1991\, she graduated with an M.Sc. in Biometry from University of Reading\, UK and has been a Chartered Statistician since 1998. Sue has over 25 years&rsquo\; experience of statistical consultancy across drug d evelopment in both CRO and pharma companies\, including collaborating with clinical colleagues on protocol development.

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\n \n Nanco Hefting
\n Lundbeck

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Nanco Hefting is Chief Scientific Specialist in the Clinical Research &ndash\; Psychiatry department at H. Lundbeck A/S\, Copenhagen\, Denmark. He has a Master of Science in pharmacy and pharmacist education from the University of Groningen\, NL\, 1991 and has worked since as a cli nical scientist and clinical lead in Clinical Pharmacology and Clinical De velopment in various companies. Nanco has been involved in the EFSPI/EFPIA estimand working group and is Co-Chair of the EIWG.

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Rikkeedit
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\n Rikke Agesen
\n Novo Nordisk< /em>

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Rikke Mette Agesen is a Senior International Medic al Manager in Global Development at Novo Nordisk. She graduated as a Medic al Doctor in 2010 from the University of Copenhagen and has several years of clinical experience within Internal Medicine and Endocrinology. Rikke h olds a PhD and a Postdoctoral position in Type 1 diabetes and hypoglycaemi a. With a physician&rsquo\;s perspective Rikke represents Novo Nordisk in the EFPIA/EFSPI estimand implementation working group (EIWG).

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Helleedit
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\n Helle Lynggaard
\n Novo Nordisk

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