PSI Training Course: Regulatory Guidelines for Statisticians

PSI Book Club - The Art of Explanation: How to Communicate with Clarity and Confidence

Develop your non-technical skills by reading The Art of Explanation by Ros Atkins and joining the Sept-Dec 2025 book club. You will be invited to join facilitated discussions of the concepts and ideas and apply skills from the book in-between sessions.

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

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.

PSI Journal Club: Missing Data

Date: Thursday 13th November 2025 Join us to hear Cesar Torres and Suzie Cro present their recent work.

Pre-Clinical SIG Webinar: Modern Algorithms for Animal Randomization in Preclinical Studies

A 1 hour online event, that includes a presentation followed by Q&A. This webinar will first define terminology in causal inference/data fusion and illustrate their use with two case studies.

PSI Medical Statistics Student Careers Event 2025

Date: 19 November 2025 This event is aimed at students with an interest in the field of Medical Statistics, for example within pharmaceuticals, healthcare and/or medical research.

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.

Panel discussion on ICH Q6b Specifications

Introduction to the topic, feedback from companies and open discussions. Brought to you by the CMC Statistical Network Europe (CSNE) SIG.

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.

Speaker	Biography
Dan Evans	Dan Evans has worked for Pfizer for over 30 years in a variety of statistical and team leadership roles leading the global development of medicines across many therapeutic areas. He has a particular focus on statistical regulatory topics and has been an active member of the PSI/EFSPI Regulatory Special Interest Group for over 15 years, participating in the co-ordination of reviews of new regulatory guidelines and policies and engagement on statistical topics with regulatory statisticians. He’s currently working as an independent statistical consultant.
Inês Antunes dos Reis	Inês has been a statistical assessor at the Medicines and Healthcare products Regulatory Agency (MHRA) since 2018. Her work focuses on assessment of marketing authorisation applications, providing scientific advice to companies, assessment of clinical investigation applications, and participating in the development of regulatory guidelines. She has over 7 years of experience in the regulatory system, having previously worked for the European Medicines Agency (EMA). She supported the ICH E9(R1) expert working group on Estimands and Sensitivity Analysis in Clinical Trials and contributed to the E9(R1) training materials published in the ICH website.
Yolanda Barbachano	Yolanda has worked as a statistician for nearly two decades, her experience spans from academia to regulatory bodies and now industry. Her interest in regulatory guidance developed whilst working over 10 years as a statistical assessor at the MHRA, and as part of the EMA system. Yolanda now works at BioNTech where she has to consider regulatory requirements for other regions. She has a PhD in statistics and a BSc in mathematics, both from the University of Sussex.
Kerry Gordon	Kerry Gordon has been in the health sector for over 40 years, mostly in the world of statistics and programming. As a past Chair of PSI, Kerry has sat on the PSI Board of Directors and has also served on the PSI Scientific, Website, Regulatory and Training subcommittees. After starting out with the NHS, he moved into the industry at (what is now) Novartis. Then, after a spell at the University of Kent, he worked for Quintiles (latterly IQVIA) for over 20 years and at Parexel for a few years. Kerry joined PHASTAR, a niche Biometrics CRO, in July last year as an Engagement Head, looking after specific customer accounts.

Speaker	Biography
Dan Evans	Dan Evans has worked for Pfizer for over 30 years in a variety of statistical and team leadership roles leading the global development of medicines across many therapeutic areas. He has a particular focus on statistical regulatory topics and has been an active member of the PSI/EFSPI Regulatory Special Interest Group for over 15 years, participating in the co-ordination of reviews of new regulatory guidelines and policies and engagement on statistical topics with regulatory statisticians. He’s currently working as an independent statistical consultant.
Inês Antunes dos Reis	Inês has been a statistical assessor at the Medicines and Healthcare products Regulatory Agency (MHRA) since 2018. Her work focuses on assessment of marketing authorisation applications, providing scientific advice to companies, assessment of clinical investigation applications, and participating in the development of regulatory guidelines. She has over 7 years of experience in the regulatory system, having previously worked for the European Medicines Agency (EMA). She supported the ICH E9(R1) expert working group on Estimands and Sensitivity Analysis in Clinical Trials and contributed to the E9(R1) training materials published in the ICH website.
Yolanda Barbachano	Yolanda has worked as a statistician for nearly two decades, her experience spans from academia to regulatory bodies and now industry. Her interest in regulatory guidance developed whilst working over 10 years as a statistical assessor at the MHRA, and as part of the EMA system. Yolanda now works at BioNTech where she has to consider regulatory requirements for other regions. She has a PhD in statistics and a BSc in mathematics, both from the University of Sussex.
Kerry Gordon	Kerry Gordon has been in the health sector for over 40 years, mostly in the world of statistics and programming. As a past Chair of PSI, Kerry has sat on the PSI Board of Directors and has also served on the PSI Scientific, Website, Regulatory and Training subcommittees. After starting out with the NHS, he moved into the industry at (what is now) Novartis. Then, after a spell at the University of Kent, he worked for Quintiles (latterly IQVIA) for over 20 years and at Parexel for a few years. Kerry joined PHASTAR, a niche Biometrics CRO, in July last year as an Engagement Head, looking after specific customer accounts.

Speaker	Biography
Dan Evans	Dan Evans has worked for Pfizer for over 30 years in a variety of statistical and team leadership roles leading the global development of medicines across many therapeutic areas. He has a particular focus on statistical regulatory topics and has been an active member of the PSI/EFSPI Regulatory Special Interest Group for over 15 years, participating in the co-ordination of reviews of new regulatory guidelines and policies and engagement on statistical topics with regulatory statisticians. He’s currently working as an independent statistical consultant.
Inês Antunes dos Reis	Inês has been a statistical assessor at the Medicines and Healthcare products Regulatory Agency (MHRA) since 2018. Her work focuses on assessment of marketing authorisation applications, providing scientific advice to companies, assessment of clinical investigation applications, and participating in the development of regulatory guidelines. She has over 7 years of experience in the regulatory system, having previously worked for the European Medicines Agency (EMA). She supported the ICH E9(R1) expert working group on Estimands and Sensitivity Analysis in Clinical Trials and contributed to the E9(R1) training materials published in the ICH website.
Yolanda Barbachano	Yolanda has worked as a statistician for nearly two decades, her experience spans from academia to regulatory bodies and now industry. Her interest in regulatory guidance developed whilst working over 10 years as a statistical assessor at the MHRA, and as part of the EMA system. Yolanda now works at BioNTech where she has to consider regulatory requirements for other regions. She has a PhD in statistics and a BSc in mathematics, both from the University of Sussex.
Kerry Gordon	Kerry Gordon has been in the health sector for over 40 years, mostly in the world of statistics and programming. As a past Chair of PSI, Kerry has sat on the PSI Board of Directors and has also served on the PSI Scientific, Website, Regulatory and Training subcommittees. After starting out with the NHS, he moved into the industry at (what is now) Novartis. Then, after a spell at the University of Kent, he worked for Quintiles (latterly IQVIA) for over 20 years and at Parexel for a few years. Kerry joined PHASTAR, a niche Biometrics CRO, in July last year as an Engagement Head, looking after specific customer accounts.

Speaker	Biography
Dan Evans	Dan Evans has worked for Pfizer for over 30 years in a variety of statistical and team leadership roles leading the global development of medicines across many therapeutic areas. He has a particular focus on statistical regulatory topics and has been an active member of the PSI/EFSPI Regulatory Special Interest Group for over 15 years, participating in the co-ordination of reviews of new regulatory guidelines and policies and engagement on statistical topics with regulatory statisticians. He’s currently working as an independent statistical consultant.
Inês Antunes dos Reis	Inês has been a statistical assessor at the Medicines and Healthcare products Regulatory Agency (MHRA) since 2018. Her work focuses on assessment of marketing authorisation applications, providing scientific advice to companies, assessment of clinical investigation applications, and participating in the development of regulatory guidelines. She has over 7 years of experience in the regulatory system, having previously worked for the European Medicines Agency (EMA). She supported the ICH E9(R1) expert working group on Estimands and Sensitivity Analysis in Clinical Trials and contributed to the E9(R1) training materials published in the ICH website.
Yolanda Barbachano	Yolanda has worked as a statistician for nearly two decades, her experience spans from academia to regulatory bodies and now industry. Her interest in regulatory guidance developed whilst working over 10 years as a statistical assessor at the MHRA, and as part of the EMA system. Yolanda now works at BioNTech where she has to consider regulatory requirements for other regions. She has a PhD in statistics and a BSc in mathematics, both from the University of Sussex.
Kerry Gordon	Kerry Gordon has been in the health sector for over 40 years, mostly in the world of statistics and programming. As a past Chair of PSI, Kerry has sat on the PSI Board of Directors and has also served on the PSI Scientific, Website, Regulatory and Training subcommittees. After starting out with the NHS, he moved into the industry at (what is now) Novartis. Then, after a spell at the University of Kent, he worked for Quintiles (latterly IQVIA) for over 20 years and at Parexel for a few years. Kerry joined PHASTAR, a niche Biometrics CRO, in July last year as an Engagement Head, looking after specific customer accounts.

Speaker	Biography
Dan Evans	Dan Evans has worked for Pfizer for over 30 years in a variety of statistical and team leadership roles leading the global development of medicines across many therapeutic areas. He has a particular focus on statistical regulatory topics and has been an active member of the PSI/EFSPI Regulatory Special Interest Group for over 15 years, participating in the co-ordination of reviews of new regulatory guidelines and policies and engagement on statistical topics with regulatory statisticians. He’s currently working as an independent statistical consultant.
Inês Antunes dos Reis	Inês has been a statistical assessor at the Medicines and Healthcare products Regulatory Agency (MHRA) since 2018. Her work focuses on assessment of marketing authorisation applications, providing scientific advice to companies, assessment of clinical investigation applications, and participating in the development of regulatory guidelines. She has over 7 years of experience in the regulatory system, having previously worked for the European Medicines Agency (EMA). She supported the ICH E9(R1) expert working group on Estimands and Sensitivity Analysis in Clinical Trials and contributed to the E9(R1) training materials published in the ICH website.
Yolanda Barbachano	Yolanda has worked as a statistician for nearly two decades, her experience spans from academia to regulatory bodies and now industry. Her interest in regulatory guidance developed whilst working over 10 years as a statistical assessor at the MHRA, and as part of the EMA system. Yolanda now works at BioNTech where she has to consider regulatory requirements for other regions. She has a PhD in statistics and a BSc in mathematics, both from the University of Sussex.
Kerry Gordon	Kerry Gordon has been in the health sector for over 40 years, mostly in the world of statistics and programming. As a past Chair of PSI, Kerry has sat on the PSI Board of Directors and has also served on the PSI Scientific, Website, Regulatory and Training subcommittees. After starting out with the NHS, he moved into the industry at (what is now) Novartis. Then, after a spell at the University of Kent, he worked for Quintiles (latterly IQVIA) for over 20 years and at Parexel for a few years. Kerry joined PHASTAR, a niche Biometrics CRO, in July last year as an Engagement Head, looking after specific customer accounts.

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