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

PSI Introduction to Industry Training (ITIT) Course - 2026/2027

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.

AIMS SIG - Open-Source Lunch Bites

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, “Graphics Basics,” will introduce the fundamentals of producing graphics using the ggplot2 package.

Connecting the False Discovery Rate to Shrunk Estimates

A 1 hour online event, that includes a presentation followed by Q&A. This talk will explore the “replication crisis” in science, focusing on how testing large numbers of hypotheses can lead to false positive findings. It introduces key statistical approaches—False Discovery Rate (FDR) and shrinkage methods—to address this issue, and explains their conceptual foundations and connections. The session will also highlight how these tools can be understood within an empirical-Bayesian framework, linking significance testing with effect size estimation.

PSI Career Young Virtual Event (Q2 2026)

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 Book Club: The AI Con – Joint with ASA Book Club

The Guardian described the authors of this book as refreshingly sarcastic! What is sold to us as AI, they announce, is just "a bill of goods": "A few major well-placed players are poised to accumulate significant wealth by extracting value from other people's creative work, personal data, or labour, and replacing quality services with artificial facsimiles."

PSI Book Club: Another Door Opens – Book Club Special Event

This is a Book Club Special Event in response to the changes in our industry and as a supportive move to create community and connection for those navigating redundancy and uncertainty. Read the book in advance of the book club session then join the zoom call to discuss ideas. There will be breakout groups to connect with others, exchange experiences of how the book has helped, and offer support.

PSI Book Club: Change: How organisations achieve hard-to-image results in uncertain and volatile times

Organizations have to adapt to the transforming landscape of our industry to ensure they continue to be successful in the future. Many of us are feeling the impact of organizational change. By reading John P Kotter’s book we can understand about organizational change and learn how to thrive, rather than just survive, through change. Change, by John P Kotter (and his team), is a summary of all that he has learned over his decades of research and leading change. His book describes why many current approaches to change are inadequate and explains why new solutions need to give people a voice and a role in a new, change-embracing organization. Develop your understanding of organisational change and become empowered to be part of your organisation’s change, by reading Change by John P Kotter and joining the Sept-Dec 2025 book club. You will be invited to join facilitated discussions of the concepts and ideas and apply knowledge from the book in-between sessions.

PSI Career Young Virtual Event (Q3 2026)

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 Career Young Virtual Event (Q4 2026)

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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