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

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.

PSI Mentoring 2026

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.

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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