PSI Vaccines SIG Webinar: Statistical designs for assessment of vaccine safety in pregnancy

PSI Introduction to Industry Training (ITIT) Course - 2025/2026

An introductory course giving an overview of the pharmaceutical industry and the drug development process as a whole, aimed at those with 1-3 years' experience. It comprises of six 2-day sessions covering a range of topics including Research and Development, Toxicology, Data Management and the Role of a CRO, Clinical Trials, Reimbursement, and Marketing.

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.

PSI Book Club Webinar: Atomic Habits - The Science of Getting Your Act Together

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PSI Webinar: Methods and tools integrating clinical trial evidence with historical or real-world data, Bayesian borrowing, and causal inference

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PSI Career Young Virtual Event (Q2 2025)

This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

PSI Webinar: Applying the Estimand Framework to Clinical Pharmacology Trials with a Case Study in Bioequivalance

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PSI Webinar: Methodology and first results of the iRISE (improving Reproducibility In SciencE) consortium

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One-day PSI/PHUSE Event: Change Management for Moving to R/Open-Source

This one-day event focuses on the comprehensive management of transitioning to R/Open-Source, addressing the challenges and providing actionable insights. Attendees will participate in sessions covering essential topics such as training best practices, creating strategic plans, making the case to senior management, and managing both statistical and programming aspects of the transition.

PSI Training Course: Pediatric Extrapolation

This course is aimed at biostatisticians with no or some pediatric drug development experience who are interested to further their understanding. 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.

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PSI/EFSPI Vaccines Statistics Workshop

The program will feature insightful sessions led by distinguished invited speakers, alongside a poster session showcasing the latest advancements in the field. Further details will be provided.

PSI Career Young Virtual Event (Q4 2025)

This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

Speaker	Biography	Abstract
Nick Andrews	Prof Nick Andrews, PhD works at the UK Health Security Agency (UKHSA) as a senior Statistician. His current job is Head of Vaccines Analysis within the Immunisation Department. He has been at UKHSA and its predecessor organisations all his career working mainly in the vaccine field. Projects he has worked on include phase 1-4 vaccine trials, retrospective cohort studies, case-control studies, self-controlled case-series studies, post licensure vaccine safety and effectiveness studies, assay development and the modelling of disease incidence. This work has led to over 500 publications. Recent work has focussed on Covid-19 vaccine studies assessing safety and effectiveness. He regularly presents results of his work to the UK Joint Committee on Vaccines and Immunisation. Prof Andrews gives lectures at the London School of Hygiene and Tropical Medicine, New York University in London, and the Global Advanced Course in Vaccinology. He is currently a member of the WHO Global Advisory Committee on Vaccine Safety and on WHO SAGE working groups on Ebola and Malaria Vaccines.	With an increasing number of vaccines recommended in pregnancy it is important to consider how best to evaluate safety. There are particular challenges in assessing safety in pregnancy such as healthy vaccinee effects, immortal time bias and biases introduced in the days close to birth. In this talk I will discuss these challenges and consider different designs with pros and cons, this will include presenting a study I have done using a nested case -control study within a cohort for Covid-19 vaccine safety and plans for a target trial emulation approach for assessing RSV vaccine in pregnancy.

Speaker	Biography	Abstract
Nick Andrews	Prof Nick Andrews, PhD works at the UK Health Security Agency (UKHSA) as a senior Statistician. His current job is Head of Vaccines Analysis within the Immunisation Department. He has been at UKHSA and its predecessor organisations all his career working mainly in the vaccine field. Projects he has worked on include phase 1-4 vaccine trials, retrospective cohort studies, case-control studies, self-controlled case-series studies, post licensure vaccine safety and effectiveness studies, assay development and the modelling of disease incidence. This work has led to over 500 publications. Recent work has focussed on Covid-19 vaccine studies assessing safety and effectiveness. He regularly presents results of his work to the UK Joint Committee on Vaccines and Immunisation. Prof Andrews gives lectures at the London School of Hygiene and Tropical Medicine, New York University in London, and the Global Advanced Course in Vaccinology. He is currently a member of the WHO Global Advisory Committee on Vaccine Safety and on WHO SAGE working groups on Ebola and Malaria Vaccines.	With an increasing number of vaccines recommended in pregnancy it is important to consider how best to evaluate safety. There are particular challenges in assessing safety in pregnancy such as healthy vaccinee effects, immortal time bias and biases introduced in the days close to birth. In this talk I will discuss these challenges and consider different designs with pros and cons, this will include presenting a study I have done using a nested case -control study within a cohort for Covid-19 vaccine safety and plans for a target trial emulation approach for assessing RSV vaccine in pregnancy.

Speaker	Biography	Abstract
Nick Andrews	Prof Nick Andrews, PhD works at the UK Health Security Agency (UKHSA) as a senior Statistician. His current job is Head of Vaccines Analysis within the Immunisation Department. He has been at UKHSA and its predecessor organisations all his career working mainly in the vaccine field. Projects he has worked on include phase 1-4 vaccine trials, retrospective cohort studies, case-control studies, self-controlled case-series studies, post licensure vaccine safety and effectiveness studies, assay development and the modelling of disease incidence. This work has led to over 500 publications. Recent work has focussed on Covid-19 vaccine studies assessing safety and effectiveness. He regularly presents results of his work to the UK Joint Committee on Vaccines and Immunisation. Prof Andrews gives lectures at the London School of Hygiene and Tropical Medicine, New York University in London, and the Global Advanced Course in Vaccinology. He is currently a member of the WHO Global Advisory Committee on Vaccine Safety and on WHO SAGE working groups on Ebola and Malaria Vaccines.	With an increasing number of vaccines recommended in pregnancy it is important to consider how best to evaluate safety. There are particular challenges in assessing safety in pregnancy such as healthy vaccinee effects, immortal time bias and biases introduced in the days close to birth. In this talk I will discuss these challenges and consider different designs with pros and cons, this will include presenting a study I have done using a nested case -control study within a cohort for Covid-19 vaccine safety and plans for a target trial emulation approach for assessing RSV vaccine in pregnancy.

Speaker	Biography	Abstract
Nick Andrews	Prof Nick Andrews, PhD works at the UK Health Security Agency (UKHSA) as a senior Statistician. His current job is Head of Vaccines Analysis within the Immunisation Department. He has been at UKHSA and its predecessor organisations all his career working mainly in the vaccine field. Projects he has worked on include phase 1-4 vaccine trials, retrospective cohort studies, case-control studies, self-controlled case-series studies, post licensure vaccine safety and effectiveness studies, assay development and the modelling of disease incidence. This work has led to over 500 publications. Recent work has focussed on Covid-19 vaccine studies assessing safety and effectiveness. He regularly presents results of his work to the UK Joint Committee on Vaccines and Immunisation. Prof Andrews gives lectures at the London School of Hygiene and Tropical Medicine, New York University in London, and the Global Advanced Course in Vaccinology. He is currently a member of the WHO Global Advisory Committee on Vaccine Safety and on WHO SAGE working groups on Ebola and Malaria Vaccines.	With an increasing number of vaccines recommended in pregnancy it is important to consider how best to evaluate safety. There are particular challenges in assessing safety in pregnancy such as healthy vaccinee effects, immortal time bias and biases introduced in the days close to birth. In this talk I will discuss these challenges and consider different designs with pros and cons, this will include presenting a study I have done using a nested case -control study within a cohort for Covid-19 vaccine safety and plans for a target trial emulation approach for assessing RSV vaccine in pregnancy.

Speaker	Biography	Abstract
Nick Andrews	Prof Nick Andrews, PhD works at the UK Health Security Agency (UKHSA) as a senior Statistician. His current job is Head of Vaccines Analysis within the Immunisation Department. He has been at UKHSA and its predecessor organisations all his career working mainly in the vaccine field. Projects he has worked on include phase 1-4 vaccine trials, retrospective cohort studies, case-control studies, self-controlled case-series studies, post licensure vaccine safety and effectiveness studies, assay development and the modelling of disease incidence. This work has led to over 500 publications. Recent work has focussed on Covid-19 vaccine studies assessing safety and effectiveness. He regularly presents results of his work to the UK Joint Committee on Vaccines and Immunisation. Prof Andrews gives lectures at the London School of Hygiene and Tropical Medicine, New York University in London, and the Global Advanced Course in Vaccinology. He is currently a member of the WHO Global Advisory Committee on Vaccine Safety and on WHO SAGE working groups on Ebola and Malaria Vaccines.	With an increasing number of vaccines recommended in pregnancy it is important to consider how best to evaluate safety. There are particular challenges in assessing safety in pregnancy such as healthy vaccinee effects, immortal time bias and biases introduced in the days close to birth. In this talk I will discuss these challenges and consider different designs with pros and cons, this will include presenting a study I have done using a nested case -control study within a cohort for Covid-19 vaccine safety and plans for a target trial emulation approach for assessing RSV vaccine in pregnancy.

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