Date: Tuesday 3rd June 2025 Time: 14:00 - 15:15 BST Location: Online via Zoom
Who is this event intended for?: Clinical pharmacology trial teams or those with a general interest in estimands.
What is the benefit of attending?: Attendees will have a better understanding of applying the estimand framework in clinical pharmacology trials.
Overview
Are you involved in designing or writing clinical pharmacology protocols? Then don't miss this webinar! We'll focus on the core concepts of estimands, specifically aimed at clinical trial development teams – no heavy statistical jargon required.
Join the expert authors of a recent paper [1] as they introduce the game-changing concepts of the “estimand framework” [2], "intercurrent events" [2], and the estimand thinking process. In this beginner-friendly session, you'll learn, step-by-step, how to apply estimand thinking to your trials, leading to clearer objectives and more meaningful results.
We'll dive into a practical case study – a bioequivalence trial – to illustrate how the estimand framework can eliminate ambiguity and bring greater transparency to the key clinical questions you're investigating. Beyond this specific example, we'll discuss the broader impact of estimands on various clinical pharmacology trials.
Come ready to learn and ask questions! The presenters will be joined by some of their co-authors for an interactive Q&A session after the presentation.
[2] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Addendum on Estimands and Sensitivity Analysis in Clinical Trials to the Guideline on Statistical Principles for Clinical Trials E9(R1). https://database.ich.org/sites/default/files/E9-R1_Step4_Guideline_2019_1203.pdf. Published November 2019
Cost
This webinar is free to both Members of PSI and Non-Members.
Sue McKendrick is a Statistical Science Director with over 30 years of industry experience in statistical consultancy across all aspects of drug development including extensive experience in PK/PD. She has presented on estimands at various conferences over the last 5 years and led a recent PSI workshop on estimands. Sue leads the Estimand Working Group at PPD and has practical experience of dozens of studies with estimands.
Mark Baird, PPD Clinical Research Services
Mark Baird is Director of Clinical Pharmacology at PPD™ clinical research business of Thermo Fisher Scientific and has over 23 years’ experience manging global teams and providing oversight and guidance across all aspects of clinical pharmacology study design, data collection, PK/PD analysis and reporting.
Helle Lynggaard, Novo Nordisk
Helle Lynggaard is a key driver in implementing estimands in Novo Nordisk studies. Helle is an active member of many EIWG sub-teams including Estimands in Clinical Pharmacology and Early Phase Trials.
David Wright, AstraZeneca
David Wright is Head of Statistical Innovation at AstraZeneca. Previously David worked for the MHRA for 16 years where he was the Chair of the Biostatistics Working Party and led the revision of the CHMP guideline on missing data in confirmatory clinical trials. This work sparked his interest in Estimands particularly on how to use the proposed framework in practice.
Judith Anzures-Cabrera, Roche Products Ltd
Judith Anzures-Cabrera, a statistician with 16 years at Roche, has worked on several therapeutic areas, focusing on Parkinson's Disease since 2019. Judith represents Roche at the EIWG. Prior to Roche, she worked at the MRC Biostatistics Unit in Cambridge and obtained her PhD from the University of Warwick.
Scientific Meetings
PSI Webinar: Applying the Estimand Framework to Clinical Pharmacology Trials with a Case Study in Bioequivalance
Date: Tuesday 3rd June 2025 Time: 14:00 - 15:15 BST Location: Online via Zoom
Who is this event intended for?: Clinical pharmacology trial teams or those with a general interest in estimands.
What is the benefit of attending?: Attendees will have a better understanding of applying the estimand framework in clinical pharmacology trials.
Overview
Are you involved in designing or writing clinical pharmacology protocols? Then don't miss this webinar! We'll focus on the core concepts of estimands, specifically aimed at clinical trial development teams – no heavy statistical jargon required.
Join the expert authors of a recent paper [1] as they introduce the game-changing concepts of the “estimand framework” [2], "intercurrent events" [2], and the estimand thinking process. In this beginner-friendly session, you'll learn, step-by-step, how to apply estimand thinking to your trials, leading to clearer objectives and more meaningful results.
We'll dive into a practical case study – a bioequivalence trial – to illustrate how the estimand framework can eliminate ambiguity and bring greater transparency to the key clinical questions you're investigating. Beyond this specific example, we'll discuss the broader impact of estimands on various clinical pharmacology trials.
Come ready to learn and ask questions! The presenters will be joined by some of their co-authors for an interactive Q&A session after the presentation.
[2] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Addendum on Estimands and Sensitivity Analysis in Clinical Trials to the Guideline on Statistical Principles for Clinical Trials E9(R1). https://database.ich.org/sites/default/files/E9-R1_Step4_Guideline_2019_1203.pdf. Published November 2019
Cost
This webinar is free to both Members of PSI and Non-Members.
Sue McKendrick is a Statistical Science Director with over 30 years of industry experience in statistical consultancy across all aspects of drug development including extensive experience in PK/PD. She has presented on estimands at various conferences over the last 5 years and led a recent PSI workshop on estimands. Sue leads the Estimand Working Group at PPD and has practical experience of dozens of studies with estimands.
Mark Baird, PPD Clinical Research Services
Mark Baird is Director of Clinical Pharmacology at PPD™ clinical research business of Thermo Fisher Scientific and has over 23 years’ experience manging global teams and providing oversight and guidance across all aspects of clinical pharmacology study design, data collection, PK/PD analysis and reporting.
Helle Lynggaard, Novo Nordisk
Helle Lynggaard is a key driver in implementing estimands in Novo Nordisk studies. Helle is an active member of many EIWG sub-teams including Estimands in Clinical Pharmacology and Early Phase Trials.
David Wright, AstraZeneca
David Wright is Head of Statistical Innovation at AstraZeneca. Previously David worked for the MHRA for 16 years where he was the Chair of the Biostatistics Working Party and led the revision of the CHMP guideline on missing data in confirmatory clinical trials. This work sparked his interest in Estimands particularly on how to use the proposed framework in practice.
Judith Anzures-Cabrera, Roche Products Ltd
Judith Anzures-Cabrera, a statistician with 16 years at Roche, has worked on several therapeutic areas, focusing on Parkinson's Disease since 2019. Judith represents Roche at the EIWG. Prior to Roche, she worked at the MRC Biostatistics Unit in Cambridge and obtained her PhD from the University of Warwick.
Training Courses
PSI Webinar: Applying the Estimand Framework to Clinical Pharmacology Trials with a Case Study in Bioequivalance
Date: Tuesday 3rd June 2025 Time: 14:00 - 15:15 BST Location: Online via Zoom
Who is this event intended for?: Clinical pharmacology trial teams or those with a general interest in estimands.
What is the benefit of attending?: Attendees will have a better understanding of applying the estimand framework in clinical pharmacology trials.
Overview
Are you involved in designing or writing clinical pharmacology protocols? Then don't miss this webinar! We'll focus on the core concepts of estimands, specifically aimed at clinical trial development teams – no heavy statistical jargon required.
Join the expert authors of a recent paper [1] as they introduce the game-changing concepts of the “estimand framework” [2], "intercurrent events" [2], and the estimand thinking process. In this beginner-friendly session, you'll learn, step-by-step, how to apply estimand thinking to your trials, leading to clearer objectives and more meaningful results.
We'll dive into a practical case study – a bioequivalence trial – to illustrate how the estimand framework can eliminate ambiguity and bring greater transparency to the key clinical questions you're investigating. Beyond this specific example, we'll discuss the broader impact of estimands on various clinical pharmacology trials.
Come ready to learn and ask questions! The presenters will be joined by some of their co-authors for an interactive Q&A session after the presentation.
[2] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Addendum on Estimands and Sensitivity Analysis in Clinical Trials to the Guideline on Statistical Principles for Clinical Trials E9(R1). https://database.ich.org/sites/default/files/E9-R1_Step4_Guideline_2019_1203.pdf. Published November 2019
Cost
This webinar is free to both Members of PSI and Non-Members.
Sue McKendrick is a Statistical Science Director with over 30 years of industry experience in statistical consultancy across all aspects of drug development including extensive experience in PK/PD. She has presented on estimands at various conferences over the last 5 years and led a recent PSI workshop on estimands. Sue leads the Estimand Working Group at PPD and has practical experience of dozens of studies with estimands.
Mark Baird, PPD Clinical Research Services
Mark Baird is Director of Clinical Pharmacology at PPD™ clinical research business of Thermo Fisher Scientific and has over 23 years’ experience manging global teams and providing oversight and guidance across all aspects of clinical pharmacology study design, data collection, PK/PD analysis and reporting.
Helle Lynggaard, Novo Nordisk
Helle Lynggaard is a key driver in implementing estimands in Novo Nordisk studies. Helle is an active member of many EIWG sub-teams including Estimands in Clinical Pharmacology and Early Phase Trials.
David Wright, AstraZeneca
David Wright is Head of Statistical Innovation at AstraZeneca. Previously David worked for the MHRA for 16 years where he was the Chair of the Biostatistics Working Party and led the revision of the CHMP guideline on missing data in confirmatory clinical trials. This work sparked his interest in Estimands particularly on how to use the proposed framework in practice.
Judith Anzures-Cabrera, Roche Products Ltd
Judith Anzures-Cabrera, a statistician with 16 years at Roche, has worked on several therapeutic areas, focusing on Parkinson's Disease since 2019. Judith represents Roche at the EIWG. Prior to Roche, she worked at the MRC Biostatistics Unit in Cambridge and obtained her PhD from the University of Warwick.
Journal Club
PSI Webinar: Applying the Estimand Framework to Clinical Pharmacology Trials with a Case Study in Bioequivalance
Date: Tuesday 3rd June 2025 Time: 14:00 - 15:15 BST Location: Online via Zoom
Who is this event intended for?: Clinical pharmacology trial teams or those with a general interest in estimands.
What is the benefit of attending?: Attendees will have a better understanding of applying the estimand framework in clinical pharmacology trials.
Overview
Are you involved in designing or writing clinical pharmacology protocols? Then don't miss this webinar! We'll focus on the core concepts of estimands, specifically aimed at clinical trial development teams – no heavy statistical jargon required.
Join the expert authors of a recent paper [1] as they introduce the game-changing concepts of the “estimand framework” [2], "intercurrent events" [2], and the estimand thinking process. In this beginner-friendly session, you'll learn, step-by-step, how to apply estimand thinking to your trials, leading to clearer objectives and more meaningful results.
We'll dive into a practical case study – a bioequivalence trial – to illustrate how the estimand framework can eliminate ambiguity and bring greater transparency to the key clinical questions you're investigating. Beyond this specific example, we'll discuss the broader impact of estimands on various clinical pharmacology trials.
Come ready to learn and ask questions! The presenters will be joined by some of their co-authors for an interactive Q&A session after the presentation.
[2] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Addendum on Estimands and Sensitivity Analysis in Clinical Trials to the Guideline on Statistical Principles for Clinical Trials E9(R1). https://database.ich.org/sites/default/files/E9-R1_Step4_Guideline_2019_1203.pdf. Published November 2019
Cost
This webinar is free to both Members of PSI and Non-Members.
Sue McKendrick is a Statistical Science Director with over 30 years of industry experience in statistical consultancy across all aspects of drug development including extensive experience in PK/PD. She has presented on estimands at various conferences over the last 5 years and led a recent PSI workshop on estimands. Sue leads the Estimand Working Group at PPD and has practical experience of dozens of studies with estimands.
Mark Baird, PPD Clinical Research Services
Mark Baird is Director of Clinical Pharmacology at PPD™ clinical research business of Thermo Fisher Scientific and has over 23 years’ experience manging global teams and providing oversight and guidance across all aspects of clinical pharmacology study design, data collection, PK/PD analysis and reporting.
Helle Lynggaard, Novo Nordisk
Helle Lynggaard is a key driver in implementing estimands in Novo Nordisk studies. Helle is an active member of many EIWG sub-teams including Estimands in Clinical Pharmacology and Early Phase Trials.
David Wright, AstraZeneca
David Wright is Head of Statistical Innovation at AstraZeneca. Previously David worked for the MHRA for 16 years where he was the Chair of the Biostatistics Working Party and led the revision of the CHMP guideline on missing data in confirmatory clinical trials. This work sparked his interest in Estimands particularly on how to use the proposed framework in practice.
Judith Anzures-Cabrera, Roche Products Ltd
Judith Anzures-Cabrera, a statistician with 16 years at Roche, has worked on several therapeutic areas, focusing on Parkinson's Disease since 2019. Judith represents Roche at the EIWG. Prior to Roche, she worked at the MRC Biostatistics Unit in Cambridge and obtained her PhD from the University of Warwick.
Webinars
PSI Webinar: Applying the Estimand Framework to Clinical Pharmacology Trials with a Case Study in Bioequivalance
Date: Tuesday 3rd June 2025 Time: 14:00 - 15:15 BST Location: Online via Zoom
Who is this event intended for?: Clinical pharmacology trial teams or those with a general interest in estimands.
What is the benefit of attending?: Attendees will have a better understanding of applying the estimand framework in clinical pharmacology trials.
Overview
Are you involved in designing or writing clinical pharmacology protocols? Then don't miss this webinar! We'll focus on the core concepts of estimands, specifically aimed at clinical trial development teams – no heavy statistical jargon required.
Join the expert authors of a recent paper [1] as they introduce the game-changing concepts of the “estimand framework” [2], "intercurrent events" [2], and the estimand thinking process. In this beginner-friendly session, you'll learn, step-by-step, how to apply estimand thinking to your trials, leading to clearer objectives and more meaningful results.
We'll dive into a practical case study – a bioequivalence trial – to illustrate how the estimand framework can eliminate ambiguity and bring greater transparency to the key clinical questions you're investigating. Beyond this specific example, we'll discuss the broader impact of estimands on various clinical pharmacology trials.
Come ready to learn and ask questions! The presenters will be joined by some of their co-authors for an interactive Q&A session after the presentation.
[2] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Addendum on Estimands and Sensitivity Analysis in Clinical Trials to the Guideline on Statistical Principles for Clinical Trials E9(R1). https://database.ich.org/sites/default/files/E9-R1_Step4_Guideline_2019_1203.pdf. Published November 2019
Cost
This webinar is free to both Members of PSI and Non-Members.
Sue McKendrick is a Statistical Science Director with over 30 years of industry experience in statistical consultancy across all aspects of drug development including extensive experience in PK/PD. She has presented on estimands at various conferences over the last 5 years and led a recent PSI workshop on estimands. Sue leads the Estimand Working Group at PPD and has practical experience of dozens of studies with estimands.
Mark Baird, PPD Clinical Research Services
Mark Baird is Director of Clinical Pharmacology at PPD™ clinical research business of Thermo Fisher Scientific and has over 23 years’ experience manging global teams and providing oversight and guidance across all aspects of clinical pharmacology study design, data collection, PK/PD analysis and reporting.
Helle Lynggaard, Novo Nordisk
Helle Lynggaard is a key driver in implementing estimands in Novo Nordisk studies. Helle is an active member of many EIWG sub-teams including Estimands in Clinical Pharmacology and Early Phase Trials.
David Wright, AstraZeneca
David Wright is Head of Statistical Innovation at AstraZeneca. Previously David worked for the MHRA for 16 years where he was the Chair of the Biostatistics Working Party and led the revision of the CHMP guideline on missing data in confirmatory clinical trials. This work sparked his interest in Estimands particularly on how to use the proposed framework in practice.
Judith Anzures-Cabrera, Roche Products Ltd
Judith Anzures-Cabrera, a statistician with 16 years at Roche, has worked on several therapeutic areas, focusing on Parkinson's Disease since 2019. Judith represents Roche at the EIWG. Prior to Roche, she worked at the MRC Biostatistics Unit in Cambridge and obtained her PhD from the University of Warwick.
Careers Meetings
PSI Webinar: Applying the Estimand Framework to Clinical Pharmacology Trials with a Case Study in Bioequivalance
Date: Tuesday 3rd June 2025 Time: 14:00 - 15:15 BST Location: Online via Zoom
Who is this event intended for?: Clinical pharmacology trial teams or those with a general interest in estimands.
What is the benefit of attending?: Attendees will have a better understanding of applying the estimand framework in clinical pharmacology trials.
Overview
Are you involved in designing or writing clinical pharmacology protocols? Then don't miss this webinar! We'll focus on the core concepts of estimands, specifically aimed at clinical trial development teams – no heavy statistical jargon required.
Join the expert authors of a recent paper [1] as they introduce the game-changing concepts of the “estimand framework” [2], "intercurrent events" [2], and the estimand thinking process. In this beginner-friendly session, you'll learn, step-by-step, how to apply estimand thinking to your trials, leading to clearer objectives and more meaningful results.
We'll dive into a practical case study – a bioequivalence trial – to illustrate how the estimand framework can eliminate ambiguity and bring greater transparency to the key clinical questions you're investigating. Beyond this specific example, we'll discuss the broader impact of estimands on various clinical pharmacology trials.
Come ready to learn and ask questions! The presenters will be joined by some of their co-authors for an interactive Q&A session after the presentation.
[2] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Addendum on Estimands and Sensitivity Analysis in Clinical Trials to the Guideline on Statistical Principles for Clinical Trials E9(R1). https://database.ich.org/sites/default/files/E9-R1_Step4_Guideline_2019_1203.pdf. Published November 2019
Cost
This webinar is free to both Members of PSI and Non-Members.
Sue McKendrick is a Statistical Science Director with over 30 years of industry experience in statistical consultancy across all aspects of drug development including extensive experience in PK/PD. She has presented on estimands at various conferences over the last 5 years and led a recent PSI workshop on estimands. Sue leads the Estimand Working Group at PPD and has practical experience of dozens of studies with estimands.
Mark Baird, PPD Clinical Research Services
Mark Baird is Director of Clinical Pharmacology at PPD™ clinical research business of Thermo Fisher Scientific and has over 23 years’ experience manging global teams and providing oversight and guidance across all aspects of clinical pharmacology study design, data collection, PK/PD analysis and reporting.
Helle Lynggaard, Novo Nordisk
Helle Lynggaard is a key driver in implementing estimands in Novo Nordisk studies. Helle is an active member of many EIWG sub-teams including Estimands in Clinical Pharmacology and Early Phase Trials.
David Wright, AstraZeneca
David Wright is Head of Statistical Innovation at AstraZeneca. Previously David worked for the MHRA for 16 years where he was the Chair of the Biostatistics Working Party and led the revision of the CHMP guideline on missing data in confirmatory clinical trials. This work sparked his interest in Estimands particularly on how to use the proposed framework in practice.
Judith Anzures-Cabrera, Roche Products Ltd
Judith Anzures-Cabrera, a statistician with 16 years at Roche, has worked on several therapeutic areas, focusing on Parkinson's Disease since 2019. Judith represents Roche at the EIWG. Prior to Roche, she worked at the MRC Biostatistics Unit in Cambridge and obtained her PhD from the University of Warwick.
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.
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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