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 Location: Online via Zoom
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.
Day 1 (15th Sept, 13:00-16:00)
Introduction - 30 min
Overview of pediatric development
Challenges and Need for pediatric research
Key Regulations and process
Pediatric plans across regions
Overview of ways to overcome challenges to conducting pediatric research
Types of Extrapolation: then vs now - 1.5 hours
No extrapolation
Partial extrapolation
Full extrapolation
Extrapolation as a continuum
Recent Use of Pediatric Extrapolation - 20 min
Day 2 (16th Sept, 13:00-16:00)
Statistical Approaches to overcome challenges in pediatric development - 3 hours
Safety evaluations
Efficacy evaluations
Bayesian designs
Adaptive designs
Platform trials
Single arm designs and the use of real world data (RWD)
Day 3 (17th Sept, 13:00-16:00)
Workshop/Practical - 2.5 hours
Summary
Required software: R (≥ 3.5.0) with pre-installed packages: ggplot2 and RBesT
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.
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.
Foteini Strimenopoulou, 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.
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 Location: Online via Zoom
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.
Day 1 (15th Sept, 13:00-16:00)
Introduction - 30 min
Overview of pediatric development
Challenges and Need for pediatric research
Key Regulations and process
Pediatric plans across regions
Overview of ways to overcome challenges to conducting pediatric research
Types of Extrapolation: then vs now - 1.5 hours
No extrapolation
Partial extrapolation
Full extrapolation
Extrapolation as a continuum
Recent Use of Pediatric Extrapolation - 20 min
Day 2 (16th Sept, 13:00-16:00)
Statistical Approaches to overcome challenges in pediatric development - 3 hours
Safety evaluations
Efficacy evaluations
Bayesian designs
Adaptive designs
Platform trials
Single arm designs and the use of real world data (RWD)
Day 3 (17th Sept, 13:00-16:00)
Workshop/Practical - 2.5 hours
Summary
Required software: R (≥ 3.5.0) with pre-installed packages: ggplot2 and RBesT
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.
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.
Foteini Strimenopoulou, 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.
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 Location: Online via Zoom
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.
Day 1 (15th Sept, 13:00-16:00)
Introduction - 30 min
Overview of pediatric development
Challenges and Need for pediatric research
Key Regulations and process
Pediatric plans across regions
Overview of ways to overcome challenges to conducting pediatric research
Types of Extrapolation: then vs now - 1.5 hours
No extrapolation
Partial extrapolation
Full extrapolation
Extrapolation as a continuum
Recent Use of Pediatric Extrapolation - 20 min
Day 2 (16th Sept, 13:00-16:00)
Statistical Approaches to overcome challenges in pediatric development - 3 hours
Safety evaluations
Efficacy evaluations
Bayesian designs
Adaptive designs
Platform trials
Single arm designs and the use of real world data (RWD)
Day 3 (17th Sept, 13:00-16:00)
Workshop/Practical - 2.5 hours
Summary
Required software: R (≥ 3.5.0) with pre-installed packages: ggplot2 and RBesT
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.
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.
Foteini Strimenopoulou, 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.
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 Location: Online via Zoom
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.
Day 1 (15th Sept, 13:00-16:00)
Introduction - 30 min
Overview of pediatric development
Challenges and Need for pediatric research
Key Regulations and process
Pediatric plans across regions
Overview of ways to overcome challenges to conducting pediatric research
Types of Extrapolation: then vs now - 1.5 hours
No extrapolation
Partial extrapolation
Full extrapolation
Extrapolation as a continuum
Recent Use of Pediatric Extrapolation - 20 min
Day 2 (16th Sept, 13:00-16:00)
Statistical Approaches to overcome challenges in pediatric development - 3 hours
Safety evaluations
Efficacy evaluations
Bayesian designs
Adaptive designs
Platform trials
Single arm designs and the use of real world data (RWD)
Day 3 (17th Sept, 13:00-16:00)
Workshop/Practical - 2.5 hours
Summary
Required software: R (≥ 3.5.0) with pre-installed packages: ggplot2 and RBesT
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.
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.
Foteini Strimenopoulou, 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.
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 Location: Online via Zoom
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.
Day 1 (15th Sept, 13:00-16:00)
Introduction - 30 min
Overview of pediatric development
Challenges and Need for pediatric research
Key Regulations and process
Pediatric plans across regions
Overview of ways to overcome challenges to conducting pediatric research
Types of Extrapolation: then vs now - 1.5 hours
No extrapolation
Partial extrapolation
Full extrapolation
Extrapolation as a continuum
Recent Use of Pediatric Extrapolation - 20 min
Day 2 (16th Sept, 13:00-16:00)
Statistical Approaches to overcome challenges in pediatric development - 3 hours
Safety evaluations
Efficacy evaluations
Bayesian designs
Adaptive designs
Platform trials
Single arm designs and the use of real world data (RWD)
Day 3 (17th Sept, 13:00-16:00)
Workshop/Practical - 2.5 hours
Summary
Required software: R (≥ 3.5.0) with pre-installed packages: ggplot2 and RBesT
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.
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.
Foteini Strimenopoulou, 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.
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 Location: Online via Zoom
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.
Day 1 (15th Sept, 13:00-16:00)
Introduction - 30 min
Overview of pediatric development
Challenges and Need for pediatric research
Key Regulations and process
Pediatric plans across regions
Overview of ways to overcome challenges to conducting pediatric research
Types of Extrapolation: then vs now - 1.5 hours
No extrapolation
Partial extrapolation
Full extrapolation
Extrapolation as a continuum
Recent Use of Pediatric Extrapolation - 20 min
Day 2 (16th Sept, 13:00-16:00)
Statistical Approaches to overcome challenges in pediatric development - 3 hours
Safety evaluations
Efficacy evaluations
Bayesian designs
Adaptive designs
Platform trials
Single arm designs and the use of real world data (RWD)
Day 3 (17th Sept, 13:00-16:00)
Workshop/Practical - 2.5 hours
Summary
Required software: R (≥ 3.5.0) with pre-installed packages: ggplot2 and RBesT
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.
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.
Foteini Strimenopoulou, 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.
Upcoming Events
Joint PSI/EFSPI Visualisation SIG 'Wonderful Wednesday' Webinars
Our monthly webinar explores examples of innovative data visualisations relevant to our day to day work. Each month a new dataset is provided from a clinical trial or other relevant example, and participants are invited to submit a graphic that communicates interesting and relevant characteristics of the data.
Topic: R Package Basics.
Our monthly webinar series allows attendees to gain practical knowledge and skills in open-source coding and tools, with a focus on applications in the pharmaceutical industry. This month’s session, “R Package Basics,” will introduce the fundamentals of working with R packages—covering how to install, load, and manage them effectively to support data analysis and reproducible research. The session will provide a solid starting point, clarify common misconceptions, and offer valuable resources for continued learning.
Date: Ongoing 6 month cycle beginning late April/early May 2026
Are you a member of PSI looking to further your career or help develop others - why not sign up to the PSI Mentoring scheme? You can expand your network, improve your leadership skills and learn from more senior colleagues in the industry.
PSI Book Club Lunch and Learn: Communicating with Clarity and Confidence
If you have read Ros Atkins’ book The Art of Explanation or want to listen to the BBC’s ‘Communicator in Chief’, you are invited to join the PSI Book Club Lunch and Learn, to discuss the content and application with the author, Ros Atkins. Having written the book within the context of the news industry, Ros is keen to hear how we have applied the ideas as statisticians within drug development and clinical trials. There will be dedicated time during the webinar to ASK THE AUTHOR any questions – don’t miss out on this exclusive PSI Book Club event!
Haven’t read the book yet? Pick up a copy today and join us.
Explanation - identifying and communicating what we want to say - is described as an art, in the title of his book. However, the creativity comes from Ros’ discernment in identifying and describing a clear step-by-step process to follow and practice. Readers can learn Ros’ rules, developed and polished throughout his career as a journalist, to help communicate complex written or spoken information clearly.
PSI Training Course: Effective Leadership – the keys to growing your leadership capabilities
This course will consist of three online half-day workshops. The first will be aimed at building trust, the backbone of leadership and a key to becoming effective. This is key to building a solid foundation.
The second will be on improving communication as a technical leader. This workshop will focus on communication strategies for different stakeholders and will involve tips on effective communication and how to develop the skills of active listening, coaching and what improv can teach us about good communication.
The final workshop will bring these two components together to help leaders become more influential. This will also focus on how to use Steven Covey’s 7-Habits, in particular Habits 4, 5 and 6, which are called the habits of communication.
The workshops will be interactive, allowing you to practice the concepts discussed. There will be plenty of time for questions and discussion. There will also be reflective time where you can think about what you are learning and how you might experiment with it.