Date: Wednesday 2nd & Thursday 3rd October 2024 Time:Day 1: 09:00-17:00 | Day 2: 09:00-16:00 BST Location:This Course will be taught in-person, at Crowne Plaza London Heathrow T4 (Terminal 4, Swindon Road, Hounslow, TW6 3FJ, United Kingdom) Speakers: Dan Evans (DMK2 Consulting Limited), Ines Antunes dos Reis (MHRA), Yolanda Barbachano (BioNTech) and Kerry Gordon (Phastar).
Who is this event intended for? Statisticians who would like to enhance their knowledge of the latest ICH and other global and regional regulatory guidelines. What is the benefit of attending? Participants will either gain or expand upon their knowledge and awareness of the regulatory environment and associated guidelines.
Cost
Early Bird PSI Members = £370+VAT PSI Members = £410+VAT
Early Bird Non-Members = £480+VAT Non-Members = £520+VAT
*Please note: Non-Member rates include PSI membership until 31 Dec. 2025.
Registration
To book your place, please click here.
Please note: - There are a limited number of places for this in-person event. Due to its popularity, we do kindly ask you to consider both the timings and location before committing to attend.
- Registration does not include hotel accommodation. If a hotel is required (as this Course runs over two consecutive days), delegates will need to book their own accommodation separately. As the Course is being held at the Crowne Plaza London Heathrow T4, we recommend booking your accommodation here. Additionally, there is a daily charge for parking, which can also be booked with the Reservations team. To make your booking, please contact the Crowne Plaza reservations team via the following: Email: Reservations5@cpheathrowt4.com Telephone: 0203 971 4182 or 0203 971 4181
Overview
The course will describe key ICH guidelines of main interest to statisticians, as well as guidance documents from regulatory bodies such as EMA, FDA, PMDA, MHRA and CDE. The focus of the course will be on the content of ICH E9 (Statistical Principles for Clinical Trials), ICH E9(R1) (Estimands and Sensitivity Analysis in Clinical Trials), ICH E10 (Choice of Control Group in Clinical Trials), ICH E6 (Good Clinical Practice), ICH E17 (Multi-Regional Clinical Trials), and ICH E20 (Adaptive Clinical Trials), but other key regulatory guidance documents will also be highlighted. The course will also include workshops, a Q&A session and guidance on how to seek advice from regulators.
Speaker details
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.
Scientific Meetings
PSI Training Course: Regulatory Guidelines for Statisticians
Date: Wednesday 2nd & Thursday 3rd October 2024 Time:Day 1: 09:00-17:00 | Day 2: 09:00-16:00 BST Location:This Course will be taught in-person, at Crowne Plaza London Heathrow T4 (Terminal 4, Swindon Road, Hounslow, TW6 3FJ, United Kingdom) Speakers: Dan Evans (DMK2 Consulting Limited), Ines Antunes dos Reis (MHRA), Yolanda Barbachano (BioNTech) and Kerry Gordon (Phastar).
Who is this event intended for? Statisticians who would like to enhance their knowledge of the latest ICH and other global and regional regulatory guidelines. What is the benefit of attending? Participants will either gain or expand upon their knowledge and awareness of the regulatory environment and associated guidelines.
Cost
Early Bird PSI Members = £370+VAT PSI Members = £410+VAT
Early Bird Non-Members = £480+VAT Non-Members = £520+VAT
*Please note: Non-Member rates include PSI membership until 31 Dec. 2025.
Registration
To book your place, please click here.
Please note: - There are a limited number of places for this in-person event. Due to its popularity, we do kindly ask you to consider both the timings and location before committing to attend.
- Registration does not include hotel accommodation. If a hotel is required (as this Course runs over two consecutive days), delegates will need to book their own accommodation separately. As the Course is being held at the Crowne Plaza London Heathrow T4, we recommend booking your accommodation here. Additionally, there is a daily charge for parking, which can also be booked with the Reservations team. To make your booking, please contact the Crowne Plaza reservations team via the following: Email: Reservations5@cpheathrowt4.com Telephone: 0203 971 4182 or 0203 971 4181
Overview
The course will describe key ICH guidelines of main interest to statisticians, as well as guidance documents from regulatory bodies such as EMA, FDA, PMDA, MHRA and CDE. The focus of the course will be on the content of ICH E9 (Statistical Principles for Clinical Trials), ICH E9(R1) (Estimands and Sensitivity Analysis in Clinical Trials), ICH E10 (Choice of Control Group in Clinical Trials), ICH E6 (Good Clinical Practice), ICH E17 (Multi-Regional Clinical Trials), and ICH E20 (Adaptive Clinical Trials), but other key regulatory guidance documents will also be highlighted. The course will also include workshops, a Q&A session and guidance on how to seek advice from regulators.
Speaker details
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.
Training Courses
PSI Training Course: Regulatory Guidelines for Statisticians
Date: Wednesday 2nd & Thursday 3rd October 2024 Time:Day 1: 09:00-17:00 | Day 2: 09:00-16:00 BST Location:This Course will be taught in-person, at Crowne Plaza London Heathrow T4 (Terminal 4, Swindon Road, Hounslow, TW6 3FJ, United Kingdom) Speakers: Dan Evans (DMK2 Consulting Limited), Ines Antunes dos Reis (MHRA), Yolanda Barbachano (BioNTech) and Kerry Gordon (Phastar).
Who is this event intended for? Statisticians who would like to enhance their knowledge of the latest ICH and other global and regional regulatory guidelines. What is the benefit of attending? Participants will either gain or expand upon their knowledge and awareness of the regulatory environment and associated guidelines.
Cost
Early Bird PSI Members = £370+VAT PSI Members = £410+VAT
Early Bird Non-Members = £480+VAT Non-Members = £520+VAT
*Please note: Non-Member rates include PSI membership until 31 Dec. 2025.
Registration
To book your place, please click here.
Please note: - There are a limited number of places for this in-person event. Due to its popularity, we do kindly ask you to consider both the timings and location before committing to attend.
- Registration does not include hotel accommodation. If a hotel is required (as this Course runs over two consecutive days), delegates will need to book their own accommodation separately. As the Course is being held at the Crowne Plaza London Heathrow T4, we recommend booking your accommodation here. Additionally, there is a daily charge for parking, which can also be booked with the Reservations team. To make your booking, please contact the Crowne Plaza reservations team via the following: Email: Reservations5@cpheathrowt4.com Telephone: 0203 971 4182 or 0203 971 4181
Overview
The course will describe key ICH guidelines of main interest to statisticians, as well as guidance documents from regulatory bodies such as EMA, FDA, PMDA, MHRA and CDE. The focus of the course will be on the content of ICH E9 (Statistical Principles for Clinical Trials), ICH E9(R1) (Estimands and Sensitivity Analysis in Clinical Trials), ICH E10 (Choice of Control Group in Clinical Trials), ICH E6 (Good Clinical Practice), ICH E17 (Multi-Regional Clinical Trials), and ICH E20 (Adaptive Clinical Trials), but other key regulatory guidance documents will also be highlighted. The course will also include workshops, a Q&A session and guidance on how to seek advice from regulators.
Speaker details
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.
Journal Club
PSI Training Course: Regulatory Guidelines for Statisticians
Date: Wednesday 2nd & Thursday 3rd October 2024 Time:Day 1: 09:00-17:00 | Day 2: 09:00-16:00 BST Location:This Course will be taught in-person, at Crowne Plaza London Heathrow T4 (Terminal 4, Swindon Road, Hounslow, TW6 3FJ, United Kingdom) Speakers: Dan Evans (DMK2 Consulting Limited), Ines Antunes dos Reis (MHRA), Yolanda Barbachano (BioNTech) and Kerry Gordon (Phastar).
Who is this event intended for? Statisticians who would like to enhance their knowledge of the latest ICH and other global and regional regulatory guidelines. What is the benefit of attending? Participants will either gain or expand upon their knowledge and awareness of the regulatory environment and associated guidelines.
Cost
Early Bird PSI Members = £370+VAT PSI Members = £410+VAT
Early Bird Non-Members = £480+VAT Non-Members = £520+VAT
*Please note: Non-Member rates include PSI membership until 31 Dec. 2025.
Registration
To book your place, please click here.
Please note: - There are a limited number of places for this in-person event. Due to its popularity, we do kindly ask you to consider both the timings and location before committing to attend.
- Registration does not include hotel accommodation. If a hotel is required (as this Course runs over two consecutive days), delegates will need to book their own accommodation separately. As the Course is being held at the Crowne Plaza London Heathrow T4, we recommend booking your accommodation here. Additionally, there is a daily charge for parking, which can also be booked with the Reservations team. To make your booking, please contact the Crowne Plaza reservations team via the following: Email: Reservations5@cpheathrowt4.com Telephone: 0203 971 4182 or 0203 971 4181
Overview
The course will describe key ICH guidelines of main interest to statisticians, as well as guidance documents from regulatory bodies such as EMA, FDA, PMDA, MHRA and CDE. The focus of the course will be on the content of ICH E9 (Statistical Principles for Clinical Trials), ICH E9(R1) (Estimands and Sensitivity Analysis in Clinical Trials), ICH E10 (Choice of Control Group in Clinical Trials), ICH E6 (Good Clinical Practice), ICH E17 (Multi-Regional Clinical Trials), and ICH E20 (Adaptive Clinical Trials), but other key regulatory guidance documents will also be highlighted. The course will also include workshops, a Q&A session and guidance on how to seek advice from regulators.
Speaker details
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.
Webinars
PSI Training Course: Regulatory Guidelines for Statisticians
Date: Wednesday 2nd & Thursday 3rd October 2024 Time:Day 1: 09:00-17:00 | Day 2: 09:00-16:00 BST Location:This Course will be taught in-person, at Crowne Plaza London Heathrow T4 (Terminal 4, Swindon Road, Hounslow, TW6 3FJ, United Kingdom) Speakers: Dan Evans (DMK2 Consulting Limited), Ines Antunes dos Reis (MHRA), Yolanda Barbachano (BioNTech) and Kerry Gordon (Phastar).
Who is this event intended for? Statisticians who would like to enhance their knowledge of the latest ICH and other global and regional regulatory guidelines. What is the benefit of attending? Participants will either gain or expand upon their knowledge and awareness of the regulatory environment and associated guidelines.
Cost
Early Bird PSI Members = £370+VAT PSI Members = £410+VAT
Early Bird Non-Members = £480+VAT Non-Members = £520+VAT
*Please note: Non-Member rates include PSI membership until 31 Dec. 2025.
Registration
To book your place, please click here.
Please note: - There are a limited number of places for this in-person event. Due to its popularity, we do kindly ask you to consider both the timings and location before committing to attend.
- Registration does not include hotel accommodation. If a hotel is required (as this Course runs over two consecutive days), delegates will need to book their own accommodation separately. As the Course is being held at the Crowne Plaza London Heathrow T4, we recommend booking your accommodation here. Additionally, there is a daily charge for parking, which can also be booked with the Reservations team. To make your booking, please contact the Crowne Plaza reservations team via the following: Email: Reservations5@cpheathrowt4.com Telephone: 0203 971 4182 or 0203 971 4181
Overview
The course will describe key ICH guidelines of main interest to statisticians, as well as guidance documents from regulatory bodies such as EMA, FDA, PMDA, MHRA and CDE. The focus of the course will be on the content of ICH E9 (Statistical Principles for Clinical Trials), ICH E9(R1) (Estimands and Sensitivity Analysis in Clinical Trials), ICH E10 (Choice of Control Group in Clinical Trials), ICH E6 (Good Clinical Practice), ICH E17 (Multi-Regional Clinical Trials), and ICH E20 (Adaptive Clinical Trials), but other key regulatory guidance documents will also be highlighted. The course will also include workshops, a Q&A session and guidance on how to seek advice from regulators.
Speaker details
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.
Careers Meetings
PSI Training Course: Regulatory Guidelines for Statisticians
Date: Wednesday 2nd & Thursday 3rd October 2024 Time:Day 1: 09:00-17:00 | Day 2: 09:00-16:00 BST Location:This Course will be taught in-person, at Crowne Plaza London Heathrow T4 (Terminal 4, Swindon Road, Hounslow, TW6 3FJ, United Kingdom) Speakers: Dan Evans (DMK2 Consulting Limited), Ines Antunes dos Reis (MHRA), Yolanda Barbachano (BioNTech) and Kerry Gordon (Phastar).
Who is this event intended for? Statisticians who would like to enhance their knowledge of the latest ICH and other global and regional regulatory guidelines. What is the benefit of attending? Participants will either gain or expand upon their knowledge and awareness of the regulatory environment and associated guidelines.
Cost
Early Bird PSI Members = £370+VAT PSI Members = £410+VAT
Early Bird Non-Members = £480+VAT Non-Members = £520+VAT
*Please note: Non-Member rates include PSI membership until 31 Dec. 2025.
Registration
To book your place, please click here.
Please note: - There are a limited number of places for this in-person event. Due to its popularity, we do kindly ask you to consider both the timings and location before committing to attend.
- Registration does not include hotel accommodation. If a hotel is required (as this Course runs over two consecutive days), delegates will need to book their own accommodation separately. As the Course is being held at the Crowne Plaza London Heathrow T4, we recommend booking your accommodation here. Additionally, there is a daily charge for parking, which can also be booked with the Reservations team. To make your booking, please contact the Crowne Plaza reservations team via the following: Email: Reservations5@cpheathrowt4.com Telephone: 0203 971 4182 or 0203 971 4181
Overview
The course will describe key ICH guidelines of main interest to statisticians, as well as guidance documents from regulatory bodies such as EMA, FDA, PMDA, MHRA and CDE. The focus of the course will be on the content of ICH E9 (Statistical Principles for Clinical Trials), ICH E9(R1) (Estimands and Sensitivity Analysis in Clinical Trials), ICH E10 (Choice of Control Group in Clinical Trials), ICH E6 (Good Clinical Practice), ICH E17 (Multi-Regional Clinical Trials), and ICH E20 (Adaptive Clinical Trials), but other key regulatory guidance documents will also be highlighted. The course will also include workshops, a Q&A session and guidance on how to seek advice from regulators.
Speaker details
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.
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.
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.
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.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
Pre-Clinical SIG Webinar: AI agents for drug discovery and development
AI agents are large language models equipped with tools that can autonomously tackle challenging tasks. This talk will explore how generative AI agents can enable biomedical discovery.
EFSPI/PSI Causal Inference SIG Webinar: Instrumental Variable Methods
The webinar is targeted at statisticians working in the pharmaceutical industry, and the objective is to 1) provide a basic understanding of IV methodology including how it relates to causal inference, and 2) present two inspirational pharma-relevant applications.
The Pre-Clinical Special Interest Group (SIG) Workshop 2025 will take place over two half-days on 7 - 8 October in Verona, Italy, bringing together experts from industry, academia, and regulatory institutions to discuss key challenges and innovations in pre-clinical research.
PSI Training Course: Introduction to Machine Learning
Four sessions will include ML foundation (including an introduction, data exploration for ML and dimensionality reduction and feature selection), Supervised learning (including support vector machines and model evaluation and interpretation), model optimization and unsupervised learning (including clustering) and advanced topics (including neural networks, deep learning and large language models).
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.
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.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
Associate Director Biostatistics in Early Development - Novartis
As an Associate Director Biostatistics Early Development, you will be a key member of our biostatistics group, you will play a crucial role in the design, analysis, and interpretation of clinical trials for early development programs.
Associate Director Biostatistics, Real World Data - Novartis
If you are passionate about biostatistics and real-world data, and are looking for an exciting opportunity to contribute to groundbreaking research, we encourage you to apply.
Are you passionate about making a difference in the world of healthcare? Novartis is seeking a dynamic and experienced professional to join our team in London at The Westworks.
Director of HTA Biostatistics & Medical Affairs - Novartis
As the Director of HTA Biostatistics & Medical Affairs, you will play a pivotal role in shaping the future of healthcare by providing strategic biostatistical leadership and expertise.
As a Senior Principal Biostatistician, you will be responsible and accountable for all statistical work, both scientific and operational, for one or more assigned clinical trials
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ARRAffinitySameSite
.psiweb.org
Session
Used to distribute traffic to the website on several servers in order to optimize response times.
__cf_bm
.vimeo.com
Cloudflare, Inc.
1 hour
The __cf_bm cookie supports Cloudflare Bot Management by managing incoming traffic that matches criteria associated with bots. The cookie does not collect any personal data, and any information collected is subject to one-way encryption.
_cfuvid
.vimeo.com
Session
Used by Cloudflare WAF to distinguish individual users who share the same IP address and apply rate limits
__cf_bm
.glueup.com
Cloudflare, Inc.
1 hour
The __cf_bm cookie supports Cloudflare Bot Management by managing incoming traffic that matches criteria associated with bots. The cookie does not collect any personal data, and any information collected is subject to one-way encryption.
AWSALBTGCORS
psi.glueup.com
7 days
AWS Classic Load Balancer Cookie: Load Balancing Cookie: Used to map the session to the instance. Same value as AWSELB.
PHPSESSID
psi.glueup.com
Session
Cookie generated by applications based on the PHP language. This is a general purpose identifier used to maintain user session variables. It is normally a random generated number, how it is used can be specific to the site, but a good example is maintaining a logged-in status for a user between pages.
Used by CookieHub to store information about whether visitors have given or declined the use of cookie categories used on the site.
Preferences
Preference cookies enables the web site to remember information to customize how the web site looks or behaves for each user. This may include storing selected currency, region, language or color theme.
Preferences
Name
Hostname
Vendor
Expiry
vuid
.vimeo.com
400 days
These cookies are used by the Vimeo video player on websites.
AWSALBCORS
psi.glueup.com
7 days
Amazon Web Services cookie. This cookie enables us to allocate server traffic to make the user experience as smooth as possible. A so-called load balancer is used to determine which server currently has the best availability. The information generated cannot identify you as an individual.
Analytical cookies
Analytical cookies help us improve our website by collecting and reporting information on its usage.