BEGIN:VCALENDAR VERSION:2.0 METHOD:PUBLISH PRODID:-//Telerik Inc.//Sitefinity CMS 13.3//EN BEGIN:VTIMEZONE TZID:UTC BEGIN:STANDARD DTSTART;VALUE=DATE:20250101 TZNAME:UTC TZOFFSETFROM:+0000 TZOFFSETTO:+0000 END:STANDARD END:VTIMEZONE BEGIN:VEVENT DESCRIPTION:Dates: \;\nSession 1 - Monday 15th September 2025\nSession 2 - Tuesday 16th September 2025\nSession 3 - Wednesday 17th September 2025 \nTime: \;13:00 - 16:00 GMT+1\nLocation: \;Online via Zoom\n\nWho is this event intended for? \;\nThis course is aimed at biostatisticia ns with no or some pediatric drug development experience who are intereste d to further their understanding. \;\n\nWhat is the benefit of attendi ng? \;\n\n Understand the pediatric drug development\, pediatric re gulation and related process.\n Gain familiarity with the statistical m ethodologies\, innovative designs and tools for extrapolation.\n Gain f amiliarity with requirements and considerations in pediatric safety evalua tion and assessment.\n\nOverview\nThis is a short course where we will giv e you an introduction to the pediatric drug development landscape. This wi ll include identifying the key regulations and processes governing pediatr ic development\, a discussion on the needs and challenges when conducting pediatric research and a focus on the ways to overcome these challenges fr om a statistical perspective. In particular\, the extrapolation concept wi ll be presented through reviews and examples. We will list and give exampl es of the use of non-standard statistical methods that can and/or have bee n used in the pediatric development. These will include the use of adaptiv e designs\, platform trials and Bayesian approaches. There will be opportu nity to put these methods into practice during the practical session.\nDay 1 (15th Sept\, 13:00-16:00)\n\n Introduction - 30 min\n \n O verview of pediatric development\n \n Challenges and Nee d for pediatric research \n Key Regulations and process\n Pediatric plans across regions\n \n \n Overview of ways to overcome challenges to conducting pediatric research \n \n \n Types of Extrapolation: then vs now - 1.5 hours\n \n No extrapolation\n Partial extrapolation\n Full extrapolation\ n Extrapolation as a continuum\n \n \n Recent Use of Pedia tric Extrapolation - 20 min\n\nDay 2 (16th Sept\, 13:00-16:00)\n\n Stat istical Approaches to overcome challenges in pediatric development - 3 hou rs\n \n Safety evaluations\n Efficacy evaluations\n \n Bayesian designs\n Adaptive designs\n Platform trials\n Single arm designs and the use of real worl d data (RWD)\n \n \n \n \n\nDay 3 (17th Sept\, 13:00-1 6:00)\n\n Workshop/Practical - 2.5 hours\n Summary\n \n \n\nRe quired software: R (&ge\; 3.5.0) with pre-installed packages: ggplot2 and RBesT\n \;\nCost\nEarly Bird PSI Members: £\;320 +VAT\nPSI Member s: £\;360 +VAT\n\nEarly Bird Non-PSI Members: £\;430 +VAT\nNon-P SI Members: £\;470 +VAT\n*Please note: Non-Member rates include PSI m embership until 31 Dec. 2025.\nRegistration\nTo register for this event\, please click here.\nSpeaker details\n\n\n\n\n \n \n \ n Speaker\n \n \n Biography\n \n \n \n \n Jingjing Ye\, BeiGene\n \n \n \n  \;Dr. Jingjing Ye is a Fellow of American Statistical Association and is current ly an executive director and global head of Data Science and Digital Innov ations (DSDI)\, with Global Statistics and Data Sciences (GSDS) in BeiGene . She leads a global team with diverse background supporting business func tions in R&\;D and outside R&\;D for their data\, analytical and tec hnology support. She has over 18 years&rsquo\; experience in pharmaceutica l industry and US FDA\, with focus in cancer drug discovery and developmen t. Her statistical and regulatory experience expands full spectrum on pati ents&rsquo\; treatment journey from diagnosis\, treatment\, to living with the condition. Her main research interest is the innovative trial designs and analyses related to small populations\, e.g.\, pediatric and rare dis eases. She received her PhD degree in statistics from University of Califo rnia\, Davis and BS in applied mathematics from Peking University. \n \n \n \n \n Foteini Strimenopoulou\, UCB\n  \;\n \n \n Foteini Strimenopoulou is a Statistical Methodology Fellow at UCB Pharma and a member of the UCB Statistical Innovation Group. Her work cen ters on developing and implementing advanced statistical methods to suppor t both early and late-phase clinical trials. With a specialization in Baye sian statistics\, she primarily focuses on designing trials for small popu lations\, including pediatric patients and individuals with rare diseases. Foteini holds a PhD in Statistics from the University of Kent (UK) and a& nbsp\;Bachelor&rsquo\;s degree in Statistics from the Athens University of Economics and Business. \n \n \n \n DTEND:20250917T160000Z DTSTAMP:20260310T001138Z DTSTART:20250915T130000Z LOCATION: SEQUENCE:0 SUMMARY:PSI Training Course: Pediatric Extrapolation UID:RFCALITEM639086982989185793 X-ALT-DESC;FMTTYPE=text/html:Dates: \;
\nSession 1 - Monday 15th September 2025
\nSession 2 - Tuesday 16th September 2 025
\nSession 3 - Wednesday 17th September 2025
\nTime:< /strong> \;13:00 - 16:00 GMT+1
\nLocation: \ ;Online via Zoom
\n
\nWho is this event intended for?&nb sp\;
\nThis course is aimed at biostatisticians with no or s ome pediatric drug development experience who are interested to further th eir understanding. \;
\n
\nWhat is the benefit of at tending? \;\n\n

Overview

\n

This is a short course where we will give you an int roduction to the pediatric drug development landscape. This will include i dentifying the key regulations and processes governing pediatric developme nt\, a discussion on the needs and challenges when conducting pediatric re search and a focus on the ways to overcome these challenges from a statist ical perspective. In particular\, the extrapolation concept will be presen ted through reviews and examples. We will list and give examples of the us e of non-standard statistical methods that can and/or have been used in th e pediatric development. These will include the use of adaptive designs\, platform trials and Bayesian approaches. There will be opportunity to put these methods into practice during the practical session.

\n

Day 1 (15th Sept\, 13:00-16:00)

\n
    \n
  1. Int roduction - 30 min\n
      \n
    1. Overview of pediatric developmen t\n
        \n
      1. Challenges and Need for pediatric researc h
        2. \n
      2. Key Regulations and process
        3. \n
      3. Pediatric plans across regions
        4. \n
      \n
      2. \n
    2. Overview of ways to overcome challenges to conducting pediatric rese arch
      3. \n
    \n
    2. \n
  2. Types of Extrapolation: then vs now - 1.5 hours\n
      \n
    1. No extrapolation
      2. \n
    2. Partial extrapolation
      3. \n
    3. Full extrapolation
      4. \n < li>Extrapolation as a continuum\n
    \n
    3. \n
  3. Recent Use of Pediatric Extrapolation - 20 min
    4. \n
\n

Day 2 (16 th Sept\, 13:00-16:00)

\n
    \n
  1. Statistical Approaches to overcome challenges in pediatric development - 3 hours\n
      \n
    1. Safety evaluations
      2. \n
    2. Efficacy evaluation s\n
        \n
      1. Bayesian designs
        2. \n
      2. Ad aptive designs
        3. \n
      3. Platform trials
        4. \n
      4. Single arm designs and the use of real world data (RWD)
        5. \n \n \n
      \n
      3. \n
    \n

    Day 3 (17t h Sept\, 13:00-16:00)

    \n
      \n
    1. Workshop/Practical - 2.5 hours
      2. \n
    2. Summary
      3. \n


      \n

      \ n
    \nRequired software: R (&ge\; 3.5.0) with pre-installed packages : ggplot2 and RBesT\n

     \;

    \n

    Cost

    \n

    Early Bird PSI Members: £\;320 +VAT
    \nPSI Members: £\;360 +VAT
    \n
    \nEarly Bird Non-PSI Members:     £\;430 +VAT
    \nNon-PSI Members:     £ \;470 +VAT
    \n*Please note: Non-Member rates include PSI membershi p until 31 Dec. 2025.

    \n

    Registration

    \n

    To register for this event\, 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
    \n

    Speaker

    \n     		\n

    Biography

    \n

    \n Jingjing Ye\, BeiGene
    \n
    \n     		\n  \;Dr. Jingjing Ye is a Fellow of American Statistica l Association and is currently an executive director and global head of Da ta Science and Digital Innovations (DSDI)\, with Global Statistics and Dat a Sciences (GSDS) in BeiGene. She leads a global team with diverse backgro und supporting business functions in R&\;D and outside R&\;D for the ir data\, analytical and technology support. She has over 18 years&rsquo\; experience in pharmaceutical industry and US FDA\, with focus in cancer d rug discovery and development. Her statistical and regulatory experience e xpands full spectrum on patients&rsquo\; treatment journey from diagnosis\ , treatment\, to living with the condition. Her main research interest is the innovative trial designs and analyses related to small populations\, e .g.\, pediatric and rare diseases. She received her PhD degree in statisti cs from University of California\, Davis and BS in applied mathematics fro m Peking University.
    \n FS Headshot\n Foteini Strimenopoulou\, UCB
    \n

     \;

    \n     		\n

    Foteini Strimenopoulou is a Statistical Methodology Fellow at UCB Phar ma and a member of the UCB Statistical Innovation Group. Her work centers on developing and implementing advanced statistical methods to support bot h early and late-phase clinical trials. With a specialization in Bayesian statistics\, she primarily focuses on designing trials for small populatio ns\, including pediatric patients and individuals with rare diseases. Fote ini holds a PhD in Statistics from the University of Kent (UK) and a \ ;Bachelor&rsquo\;s degree in Statistics from the Athens University of Econ omics and Business.

    \n
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