PSI Training Course: Pediatric Extrapolation

Event Details

Who is this event intended for?: This course is aimed at biostatisticians with no or some pediatric drug development experience who are interested to further their understanding.

What is the benefit of attending?:

· Understand the pediatric drug development, pediatric regulation and related process.

· Gain familiarity with the statistical methodologies, innovative designs and tools for extrapolation.

· Gain familiarity with requirements and considerations in pediatric safety evaluation and assessment.

Overview: This is a short course where we will give you an introduction to the pediatric drug development landscape. This will include identifying the key regulations and processes governing pediatric development, a discussion on the needs and challenges when conducting pediatric research and a focus on the ways to overcome these challenges from a statistical perspective. In particular, the extrapolation concept will be presented through reviews and examples. We will list and give examples of the use of non-standard statistical methods that can and/or have been used in the 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.

Dates:

Session 1 - Monday 15th September 2025

Session 2 - Tuesday 16th September 2025

Session 3 - Wednesday 17th September 2025

Time: 13:00 - 16:00 GMT+1

Cost:

Early Bird PSI Members: £320 +VAT

PSI Members:£360 +VAT

Early Bird Non-PSI Members: £430 +VAT

Non-PSI Members: £470 +VAT

*Please note: Non-Member rates include PSI membership until 31 Dec. 2025.

Speakers

Jingjing Ye
Executive Director, Global head of Data Science and Digital Innovations (DSDI), Global Statistics and Data Sciences (GSDS) at BeiGene
Dr. Jingjing Ye is a Fellow of American Statistical Association and is currently an executive director and global head of Data Science and Digital Innovations (DSDI), with Global Statistics and Data Sciences (GSDS) in BeiGene. She leads a global team with diverse background supporting business functions in R&D and outside R&D for their data, analytical and technology support. She has over 18 years’ experience in pharmaceutical industry and US FDA, with focus in cancer drug discovery and development. Her statistical and regulatory experience expands full spectrum on patients’ 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 statistics from University of California, Davis and BS in applied mathematics from Peking University.
view more
Foteini Strimenopoulou
Senior Director, Statistical Methodology Fellow of UCB
Foteini Strimenopoulou is a Statistical Methodology Fellow at UCB Pharma and a member of the UCB Statistical Innovation Group. Her work centers on developing and implementing advanced statistical methods to support both early and late-phase clinical trials. With a specialization in Bayesian statistics, she primarily focuses on designing trials for small populations, including pediatric patients and individuals with rare diseases. Foteini holds a PhD in Statistics from the University of Kent (UK) and a Bachelor’s degree in Statistics from the Athens University of Economics and Business.
view more