Date: Tuesday 2nd July 2024
Time: 14:00-15:30 BST | 15:00-16:30 CEST
Location: Online via Zoom
Speakers: Rachid Abbas, Angeliki Thanasopoulou, and Marcel Wolbers (Roche).
Who is this event intended for? Clinicians, Regulators, Investigators, Academics, members of Ethics Committees, Health technology assessors, Statisticians.
What is the benefit of attending?
● To illustrate the purpose of each estimand attributes using simple language in a pivotal study in early Alzheimer's disease
● Recognize the benefits of following the estimand framework (ICH E9 (R1) addendum) in the context of a clinical trial, in order to:
- gain alignment on the question(s) of interest
- frame questions which may be of interest to different stakeholders
- be transparent when communicating trial results
This event is free to both Members of PSI and Non-Members. To register your place for this event, please click here.
The webinar will show how the estimand framework was applied in a Phase 3 trial in Alzheimer's disease.
GRADUATE I(NCT03444870) and GRADUATE II (NCT03443973) were two global, Phase III, randomized, placebo-controlled trials assessing the efficacy and safety of gantenerumab in early Alzheimer's disease. The GRADUATE studies were among the first pivotal trials in Alzheimer's Disease to adopt the estimand framework and to conduct a primary analysis which is fully aligned with the targeted estimand.
In this webinar we will review the key elements of the estimand framework through the experience of the Graduate study team. We will review how the Graduate study team interpreted the estimand framework and used its elements to cover the primary clinical question of interest. We will review the challenges we met and the solutions we implemented.
This webinar will be interactive. Questions will be raised at different points during the talk and we will end with 30 minutes dedicated to answer open questions.
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Speaker |
Biography |
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Rachid Abbas is a statistician in Roche's Product Development department since 2020. With a medical degree in public health and a Master’s in biostatistics, he has a strong interest in statistical issues in drug development. Rachid has held academic positions at Paris Diderot University and Gustave Roussy, contributing to clinical trials in geriatrics and neuro-oncology. At Roche, he supports late-phase Alzheimer's Disease programs. His research interests include the design and analysis of innovative clinical trials, including adaptive designs, estimands, and trial emulation.
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Angeliki is a Senior Clinical Scientist in the Alzheimer’s Disease & Neurodegeneration Franchise at Roche since 2019. She has previously worked in clinical development in a small size biotech focusing on rare diseases in neuromuscular, neurodegenerative and respiratory indications, across Phase 1 up to Phase 4 studies. Prior to joining the Pharmaceutical Industry she completed a postdoctoral position in the University Hospital Basel working on translational research and Investigator Initiated Trials. Angeliki is a biologist in training with a masters and PhD in molecular and cellular biology.
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Since completing his PhD in mathematical statistics in 2002, Marcel Wolbers has spent half of his career as an academic biostatistician and the other half as a statistician in the pharmaceutical industry. Between 2009 and 2016, he was the head of biostatistics at the Oxford University Clinical Research Unit in Ho Chi Minh City, Vietnam. Since 2016, he has been an expert statistician working in the Methods, Collaboration, and Outreach group (MCO) of Roche's data sciences and statistics department. His research interests include the design and analysis of innovative clinical trials, estimands, missing data, prognostic models, and competing risks.
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Date: Tuesday 2nd July 2024
Time: 14:00-15:30 BST | 15:00-16:30 CEST
Location: Online via Zoom
Speakers: Rachid Abbas, Angeliki Thanasopoulou, and Marcel Wolbers (Roche).
Who is this event intended for? Clinicians, Regulators, Investigators, Academics, members of Ethics Committees, Health technology assessors, Statisticians.
What is the benefit of attending?
● To illustrate the purpose of each estimand attributes using simple language in a pivotal study in early Alzheimer's disease
● Recognize the benefits of following the estimand framework (ICH E9 (R1) addendum) in the context of a clinical trial, in order to:
- gain alignment on the question(s) of interest
- frame questions which may be of interest to different stakeholders
- be transparent when communicating trial results
This event is free to both Members of PSI and Non-Members. To register your place for this event, please click here.
The webinar will show how the estimand framework was applied in a Phase 3 trial in Alzheimer's disease.
GRADUATE I(NCT03444870) and GRADUATE II (NCT03443973) were two global, Phase III, randomized, placebo-controlled trials assessing the efficacy and safety of gantenerumab in early Alzheimer's disease. The GRADUATE studies were among the first pivotal trials in Alzheimer's Disease to adopt the estimand framework and to conduct a primary analysis which is fully aligned with the targeted estimand.
In this webinar we will review the key elements of the estimand framework through the experience of the Graduate study team. We will review how the Graduate study team interpreted the estimand framework and used its elements to cover the primary clinical question of interest. We will review the challenges we met and the solutions we implemented.
This webinar will be interactive. Questions will be raised at different points during the talk and we will end with 30 minutes dedicated to answer open questions.
|
Speaker |
Biography |
|
|
Rachid Abbas is a statistician in Roche's Product Development department since 2020. With a medical degree in public health and a Master’s in biostatistics, he has a strong interest in statistical issues in drug development. Rachid has held academic positions at Paris Diderot University and Gustave Roussy, contributing to clinical trials in geriatrics and neuro-oncology. At Roche, he supports late-phase Alzheimer's Disease programs. His research interests include the design and analysis of innovative clinical trials, including adaptive designs, estimands, and trial emulation.
|
|
|
Angeliki is a Senior Clinical Scientist in the Alzheimer’s Disease & Neurodegeneration Franchise at Roche since 2019. She has previously worked in clinical development in a small size biotech focusing on rare diseases in neuromuscular, neurodegenerative and respiratory indications, across Phase 1 up to Phase 4 studies. Prior to joining the Pharmaceutical Industry she completed a postdoctoral position in the University Hospital Basel working on translational research and Investigator Initiated Trials. Angeliki is a biologist in training with a masters and PhD in molecular and cellular biology.
|
|
|
Since completing his PhD in mathematical statistics in 2002, Marcel Wolbers has spent half of his career as an academic biostatistician and the other half as a statistician in the pharmaceutical industry. Between 2009 and 2016, he was the head of biostatistics at the Oxford University Clinical Research Unit in Ho Chi Minh City, Vietnam. Since 2016, he has been an expert statistician working in the Methods, Collaboration, and Outreach group (MCO) of Roche's data sciences and statistics department. His research interests include the design and analysis of innovative clinical trials, estimands, missing data, prognostic models, and competing risks.
|
Date: Tuesday 2nd July 2024
Time: 14:00-15:30 BST | 15:00-16:30 CEST
Location: Online via Zoom
Speakers: Rachid Abbas, Angeliki Thanasopoulou, and Marcel Wolbers (Roche).
Who is this event intended for? Clinicians, Regulators, Investigators, Academics, members of Ethics Committees, Health technology assessors, Statisticians.
What is the benefit of attending?
● To illustrate the purpose of each estimand attributes using simple language in a pivotal study in early Alzheimer's disease
● Recognize the benefits of following the estimand framework (ICH E9 (R1) addendum) in the context of a clinical trial, in order to:
- gain alignment on the question(s) of interest
- frame questions which may be of interest to different stakeholders
- be transparent when communicating trial results
This event is free to both Members of PSI and Non-Members. To register your place for this event, please click here.
The webinar will show how the estimand framework was applied in a Phase 3 trial in Alzheimer's disease.
GRADUATE I(NCT03444870) and GRADUATE II (NCT03443973) were two global, Phase III, randomized, placebo-controlled trials assessing the efficacy and safety of gantenerumab in early Alzheimer's disease. The GRADUATE studies were among the first pivotal trials in Alzheimer's Disease to adopt the estimand framework and to conduct a primary analysis which is fully aligned with the targeted estimand.
In this webinar we will review the key elements of the estimand framework through the experience of the Graduate study team. We will review how the Graduate study team interpreted the estimand framework and used its elements to cover the primary clinical question of interest. We will review the challenges we met and the solutions we implemented.
This webinar will be interactive. Questions will be raised at different points during the talk and we will end with 30 minutes dedicated to answer open questions.
|
Speaker |
Biography |
|
|
Rachid Abbas is a statistician in Roche's Product Development department since 2020. With a medical degree in public health and a Master’s in biostatistics, he has a strong interest in statistical issues in drug development. Rachid has held academic positions at Paris Diderot University and Gustave Roussy, contributing to clinical trials in geriatrics and neuro-oncology. At Roche, he supports late-phase Alzheimer's Disease programs. His research interests include the design and analysis of innovative clinical trials, including adaptive designs, estimands, and trial emulation.
|
|
|
Angeliki is a Senior Clinical Scientist in the Alzheimer’s Disease & Neurodegeneration Franchise at Roche since 2019. She has previously worked in clinical development in a small size biotech focusing on rare diseases in neuromuscular, neurodegenerative and respiratory indications, across Phase 1 up to Phase 4 studies. Prior to joining the Pharmaceutical Industry she completed a postdoctoral position in the University Hospital Basel working on translational research and Investigator Initiated Trials. Angeliki is a biologist in training with a masters and PhD in molecular and cellular biology.
|
|
|
Since completing his PhD in mathematical statistics in 2002, Marcel Wolbers has spent half of his career as an academic biostatistician and the other half as a statistician in the pharmaceutical industry. Between 2009 and 2016, he was the head of biostatistics at the Oxford University Clinical Research Unit in Ho Chi Minh City, Vietnam. Since 2016, he has been an expert statistician working in the Methods, Collaboration, and Outreach group (MCO) of Roche's data sciences and statistics department. His research interests include the design and analysis of innovative clinical trials, estimands, missing data, prognostic models, and competing risks.
|
Date: Tuesday 2nd July 2024
Time: 14:00-15:30 BST | 15:00-16:30 CEST
Location: Online via Zoom
Speakers: Rachid Abbas, Angeliki Thanasopoulou, and Marcel Wolbers (Roche).
Who is this event intended for? Clinicians, Regulators, Investigators, Academics, members of Ethics Committees, Health technology assessors, Statisticians.
What is the benefit of attending?
● To illustrate the purpose of each estimand attributes using simple language in a pivotal study in early Alzheimer's disease
● Recognize the benefits of following the estimand framework (ICH E9 (R1) addendum) in the context of a clinical trial, in order to:
- gain alignment on the question(s) of interest
- frame questions which may be of interest to different stakeholders
- be transparent when communicating trial results
This event is free to both Members of PSI and Non-Members. To register your place for this event, please click here.
The webinar will show how the estimand framework was applied in a Phase 3 trial in Alzheimer's disease.
GRADUATE I(NCT03444870) and GRADUATE II (NCT03443973) were two global, Phase III, randomized, placebo-controlled trials assessing the efficacy and safety of gantenerumab in early Alzheimer's disease. The GRADUATE studies were among the first pivotal trials in Alzheimer's Disease to adopt the estimand framework and to conduct a primary analysis which is fully aligned with the targeted estimand.
In this webinar we will review the key elements of the estimand framework through the experience of the Graduate study team. We will review how the Graduate study team interpreted the estimand framework and used its elements to cover the primary clinical question of interest. We will review the challenges we met and the solutions we implemented.
This webinar will be interactive. Questions will be raised at different points during the talk and we will end with 30 minutes dedicated to answer open questions.
|
Speaker |
Biography |
|
|
Rachid Abbas is a statistician in Roche's Product Development department since 2020. With a medical degree in public health and a Master’s in biostatistics, he has a strong interest in statistical issues in drug development. Rachid has held academic positions at Paris Diderot University and Gustave Roussy, contributing to clinical trials in geriatrics and neuro-oncology. At Roche, he supports late-phase Alzheimer's Disease programs. His research interests include the design and analysis of innovative clinical trials, including adaptive designs, estimands, and trial emulation.
|
|
|
Angeliki is a Senior Clinical Scientist in the Alzheimer’s Disease & Neurodegeneration Franchise at Roche since 2019. She has previously worked in clinical development in a small size biotech focusing on rare diseases in neuromuscular, neurodegenerative and respiratory indications, across Phase 1 up to Phase 4 studies. Prior to joining the Pharmaceutical Industry she completed a postdoctoral position in the University Hospital Basel working on translational research and Investigator Initiated Trials. Angeliki is a biologist in training with a masters and PhD in molecular and cellular biology.
|
|
|
Since completing his PhD in mathematical statistics in 2002, Marcel Wolbers has spent half of his career as an academic biostatistician and the other half as a statistician in the pharmaceutical industry. Between 2009 and 2016, he was the head of biostatistics at the Oxford University Clinical Research Unit in Ho Chi Minh City, Vietnam. Since 2016, he has been an expert statistician working in the Methods, Collaboration, and Outreach group (MCO) of Roche's data sciences and statistics department. His research interests include the design and analysis of innovative clinical trials, estimands, missing data, prognostic models, and competing risks.
|
Date: Tuesday 2nd July 2024
Time: 14:00-15:30 BST | 15:00-16:30 CEST
Location: Online via Zoom
Speakers: Rachid Abbas, Angeliki Thanasopoulou, and Marcel Wolbers (Roche).
Who is this event intended for? Clinicians, Regulators, Investigators, Academics, members of Ethics Committees, Health technology assessors, Statisticians.
What is the benefit of attending?
● To illustrate the purpose of each estimand attributes using simple language in a pivotal study in early Alzheimer's disease
● Recognize the benefits of following the estimand framework (ICH E9 (R1) addendum) in the context of a clinical trial, in order to:
- gain alignment on the question(s) of interest
- frame questions which may be of interest to different stakeholders
- be transparent when communicating trial results
This event is free to both Members of PSI and Non-Members. To register your place for this event, please click here.
The webinar will show how the estimand framework was applied in a Phase 3 trial in Alzheimer's disease.
GRADUATE I(NCT03444870) and GRADUATE II (NCT03443973) were two global, Phase III, randomized, placebo-controlled trials assessing the efficacy and safety of gantenerumab in early Alzheimer's disease. The GRADUATE studies were among the first pivotal trials in Alzheimer's Disease to adopt the estimand framework and to conduct a primary analysis which is fully aligned with the targeted estimand.
In this webinar we will review the key elements of the estimand framework through the experience of the Graduate study team. We will review how the Graduate study team interpreted the estimand framework and used its elements to cover the primary clinical question of interest. We will review the challenges we met and the solutions we implemented.
This webinar will be interactive. Questions will be raised at different points during the talk and we will end with 30 minutes dedicated to answer open questions.
|
Speaker |
Biography |
|
|
Rachid Abbas is a statistician in Roche's Product Development department since 2020. With a medical degree in public health and a Master’s in biostatistics, he has a strong interest in statistical issues in drug development. Rachid has held academic positions at Paris Diderot University and Gustave Roussy, contributing to clinical trials in geriatrics and neuro-oncology. At Roche, he supports late-phase Alzheimer's Disease programs. His research interests include the design and analysis of innovative clinical trials, including adaptive designs, estimands, and trial emulation.
|
|
|
Angeliki is a Senior Clinical Scientist in the Alzheimer’s Disease & Neurodegeneration Franchise at Roche since 2019. She has previously worked in clinical development in a small size biotech focusing on rare diseases in neuromuscular, neurodegenerative and respiratory indications, across Phase 1 up to Phase 4 studies. Prior to joining the Pharmaceutical Industry she completed a postdoctoral position in the University Hospital Basel working on translational research and Investigator Initiated Trials. Angeliki is a biologist in training with a masters and PhD in molecular and cellular biology.
|
|
|
Since completing his PhD in mathematical statistics in 2002, Marcel Wolbers has spent half of his career as an academic biostatistician and the other half as a statistician in the pharmaceutical industry. Between 2009 and 2016, he was the head of biostatistics at the Oxford University Clinical Research Unit in Ho Chi Minh City, Vietnam. Since 2016, he has been an expert statistician working in the Methods, Collaboration, and Outreach group (MCO) of Roche's data sciences and statistics department. His research interests include the design and analysis of innovative clinical trials, estimands, missing data, prognostic models, and competing risks.
|
Date: Tuesday 2nd July 2024
Time: 14:00-15:30 BST | 15:00-16:30 CEST
Location: Online via Zoom
Speakers: Rachid Abbas, Angeliki Thanasopoulou, and Marcel Wolbers (Roche).
Who is this event intended for? Clinicians, Regulators, Investigators, Academics, members of Ethics Committees, Health technology assessors, Statisticians.
What is the benefit of attending?
● To illustrate the purpose of each estimand attributes using simple language in a pivotal study in early Alzheimer's disease
● Recognize the benefits of following the estimand framework (ICH E9 (R1) addendum) in the context of a clinical trial, in order to:
- gain alignment on the question(s) of interest
- frame questions which may be of interest to different stakeholders
- be transparent when communicating trial results
This event is free to both Members of PSI and Non-Members. To register your place for this event, please click here.
The webinar will show how the estimand framework was applied in a Phase 3 trial in Alzheimer's disease.
GRADUATE I(NCT03444870) and GRADUATE II (NCT03443973) were two global, Phase III, randomized, placebo-controlled trials assessing the efficacy and safety of gantenerumab in early Alzheimer's disease. The GRADUATE studies were among the first pivotal trials in Alzheimer's Disease to adopt the estimand framework and to conduct a primary analysis which is fully aligned with the targeted estimand.
In this webinar we will review the key elements of the estimand framework through the experience of the Graduate study team. We will review how the Graduate study team interpreted the estimand framework and used its elements to cover the primary clinical question of interest. We will review the challenges we met and the solutions we implemented.
This webinar will be interactive. Questions will be raised at different points during the talk and we will end with 30 minutes dedicated to answer open questions.
|
Speaker |
Biography |
|
|
Rachid Abbas is a statistician in Roche's Product Development department since 2020. With a medical degree in public health and a Master’s in biostatistics, he has a strong interest in statistical issues in drug development. Rachid has held academic positions at Paris Diderot University and Gustave Roussy, contributing to clinical trials in geriatrics and neuro-oncology. At Roche, he supports late-phase Alzheimer's Disease programs. His research interests include the design and analysis of innovative clinical trials, including adaptive designs, estimands, and trial emulation.
|
|
|
Angeliki is a Senior Clinical Scientist in the Alzheimer’s Disease & Neurodegeneration Franchise at Roche since 2019. She has previously worked in clinical development in a small size biotech focusing on rare diseases in neuromuscular, neurodegenerative and respiratory indications, across Phase 1 up to Phase 4 studies. Prior to joining the Pharmaceutical Industry she completed a postdoctoral position in the University Hospital Basel working on translational research and Investigator Initiated Trials. Angeliki is a biologist in training with a masters and PhD in molecular and cellular biology.
|
|
|
Since completing his PhD in mathematical statistics in 2002, Marcel Wolbers has spent half of his career as an academic biostatistician and the other half as a statistician in the pharmaceutical industry. Between 2009 and 2016, he was the head of biostatistics at the Oxford University Clinical Research Unit in Ho Chi Minh City, Vietnam. Since 2016, he has been an expert statistician working in the Methods, Collaboration, and Outreach group (MCO) of Roche's data sciences and statistics department. His research interests include the design and analysis of innovative clinical trials, estimands, missing data, prognostic models, and competing risks.
|
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.
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.
The book club’s usual focus is to read and discuss professional development books. In this short format event you can more easily develop you career without the commitment of reading the whole book - simply listen to the 1-hour long podcast before joining the interactive session on 21 May.
This webinar is organised by the RWD SIG and the Historical Data SIG. We will review recent methods, applications, and tools of integrating subject-level-data from clinical trial with external data using Bayesian methods and/or causal inference methods.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
This will be a 45 minute webinar which will explain the topic presented in the published paper, ‘Applying the Estimand Framework to Clinical Pharmacology Trials with a Case Study in Bioequivalance’. There will be 15 minutes for a panel Q&A with some of the authors following the presentation.
This 1-hour webinar will be an opportunity to hear about the methodology and first results of the iRISE consortium. iRISE is working towards a better understanding of reproducibility and the interventions that work to improve it. At the end of the presentation there will also be the opportunity to ask questions.
This one-day event focuses on the comprehensive management of transitioning to R/Open-Source, addressing the challenges and providing actionable insights. Attendees will participate in sessions covering essential topics such as training best practices, creating strategic plans, making the case to senior management, and managing both statistical and programming aspects of the transition.
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.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
This is an exciting, new opportunity for an experienced Statistician looking to take the next step in their career. Offered as a remote or hybrid position aligned with our site in Harrogate, North Yorkshire.
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