Date: Tuesday 22nd March 2022
Time: 13:30-15:00 GMT | 09:30-11:00 ET
Speakers: Tae Hyun Jung (U.S. Food and Drug Administration), Tim Weaver (Chronic Disease Research Group), Richard Croy (Astellas), David Nimke (Astellas) and Josephine Wolfram (Astellas)
Who is this event intended for? Statisticians or other professionals with an interest in the use of real world data in the regulatory setting.
What is the benefit of attending? To hear first-hand experience of a successful RWE-based submission from different stakeholder perspectives.
You can now register for this event. Registration fees are as follows:
- Members of PSI = Free of charge
- Non-Members of PSI =Free of charge
To register for the session, please click here.
The FDA Real-World Evidence (RWE) Framework was published in Dec. 2018, shedding some light on how Real-World Data (RWD) can be used to support regulatory decision making. This guidance was greatly welcomed in an environment that focuses on efficiency and innovative trial designs. Yet, three years out, there are not many examples of RWE in practice, especially of situations where RWE is the exclusive source of evidence supporting new drug indications. Recently, tacrolimus was approved for Lung transplantation based solely on RWE and we would like to share our experience with statisticians in the pharmaceutical community.
Three stakeholders – the sponsor, RWD vendor and FDA - will share their experiences of the submission and approval process. Topics to be covered include relevant project background & context, identification/selection of RWD, study design & key analysis methods, operational considerations related to study conduct & quality, submission content and labeling.
|
Speakers |
Biographies |
Abstract |
|
|
Rick has been working in clinical development as a statistician in the pharmaceutical industry for over 20 years. For more than 10 of those years, he has been a global statistical lead on various projects, including tacrolimus for transplantation. David is the Real World Evidence-US Lead at Astellas Advanced Informatics and Analytics. His team of observational researchers and analysts conduct research using secondary use databases. Previously, he worked in epidemiology and RWE groups at Astellas, AbbVie, and Abbott Laboratories. David holds a Doctor of Public Health from University of North Carolina. Josie joined the pharmaceutical industry 25 years ago. Following a few years at GSK, she joined Fujisawa in Munich then Astellas in the Netherlands in various statistical roles. She currently leads a small team focused on leveraging real world data to support development projects. |
Richard Croy, David Nimke and Josephine Wolfram will share the background and rationale to pursue this submission, the approach, and key discussion points with the FDA leading up to the submission and during review. Considerations for the choice of RWE and Real-World Data (RWD) used in the pivotal RWD study will be discussed along with the study design elements, key results and challenges. Operational considerations for study conduct and submission will also be addressed |
|
|
Tim Weaver works as a biostatistician in the area of organ transplantation with the Chronic Disease Research Group. In that role he has conducted research using the SRTR database as well as simulation analysis of the organ allocation system. |
Tim Weaver will discuss the source of the RWD, the Scientific Registry of Transplant Recipients database, and the observational nature of the data with its implications for the study design and considerations for analysis. Technical aspects of the data-processing code development, data transfer, and results submission will also be discussed. |
|
|
Tae Hyun Jung, Ph.D., is a Senior Statistical Reviewer in FDA/CDER/OTS/OB/DBVII. He has comprehensive NDA/BLA/PMR review experience from phase III/phase IV safety focused reviews, and phase III efficacy reviews including RWE efficacy. He is also leading multiple RWE/RWD research projects using machine learning/artificial intelligence, evidence synthesis, data quality, and synthetic data. Tae Hyun completed his PhD degree in Biostatistics at Yale University. |
Tae Hyun Jung will share FDA review perspectives and challenges during the review process. Also, the importance of getting quality patient-level data in RWE submission will be addressed. |
Date: Tuesday 22nd March 2022
Time: 13:30-15:00 GMT | 09:30-11:00 ET
Speakers: Tae Hyun Jung (U.S. Food and Drug Administration), Tim Weaver (Chronic Disease Research Group), Richard Croy (Astellas), David Nimke (Astellas) and Josephine Wolfram (Astellas)
Who is this event intended for? Statisticians or other professionals with an interest in the use of real world data in the regulatory setting.
What is the benefit of attending? To hear first-hand experience of a successful RWE-based submission from different stakeholder perspectives.
You can now register for this event. Registration fees are as follows:
- Members of PSI = Free of charge
- Non-Members of PSI =Free of charge
To register for the session, please click here.
The FDA Real-World Evidence (RWE) Framework was published in Dec. 2018, shedding some light on how Real-World Data (RWD) can be used to support regulatory decision making. This guidance was greatly welcomed in an environment that focuses on efficiency and innovative trial designs. Yet, three years out, there are not many examples of RWE in practice, especially of situations where RWE is the exclusive source of evidence supporting new drug indications. Recently, tacrolimus was approved for Lung transplantation based solely on RWE and we would like to share our experience with statisticians in the pharmaceutical community.
Three stakeholders – the sponsor, RWD vendor and FDA - will share their experiences of the submission and approval process. Topics to be covered include relevant project background & context, identification/selection of RWD, study design & key analysis methods, operational considerations related to study conduct & quality, submission content and labeling.
|
Speakers |
Biographies |
Abstract |
|
|
Rick has been working in clinical development as a statistician in the pharmaceutical industry for over 20 years. For more than 10 of those years, he has been a global statistical lead on various projects, including tacrolimus for transplantation. David is the Real World Evidence-US Lead at Astellas Advanced Informatics and Analytics. His team of observational researchers and analysts conduct research using secondary use databases. Previously, he worked in epidemiology and RWE groups at Astellas, AbbVie, and Abbott Laboratories. David holds a Doctor of Public Health from University of North Carolina. Josie joined the pharmaceutical industry 25 years ago. Following a few years at GSK, she joined Fujisawa in Munich then Astellas in the Netherlands in various statistical roles. She currently leads a small team focused on leveraging real world data to support development projects. |
Richard Croy, David Nimke and Josephine Wolfram will share the background and rationale to pursue this submission, the approach, and key discussion points with the FDA leading up to the submission and during review. Considerations for the choice of RWE and Real-World Data (RWD) used in the pivotal RWD study will be discussed along with the study design elements, key results and challenges. Operational considerations for study conduct and submission will also be addressed |
|
|
Tim Weaver works as a biostatistician in the area of organ transplantation with the Chronic Disease Research Group. In that role he has conducted research using the SRTR database as well as simulation analysis of the organ allocation system. |
Tim Weaver will discuss the source of the RWD, the Scientific Registry of Transplant Recipients database, and the observational nature of the data with its implications for the study design and considerations for analysis. Technical aspects of the data-processing code development, data transfer, and results submission will also be discussed. |
|
|
Tae Hyun Jung, Ph.D., is a Senior Statistical Reviewer in FDA/CDER/OTS/OB/DBVII. He has comprehensive NDA/BLA/PMR review experience from phase III/phase IV safety focused reviews, and phase III efficacy reviews including RWE efficacy. He is also leading multiple RWE/RWD research projects using machine learning/artificial intelligence, evidence synthesis, data quality, and synthetic data. Tae Hyun completed his PhD degree in Biostatistics at Yale University. |
Tae Hyun Jung will share FDA review perspectives and challenges during the review process. Also, the importance of getting quality patient-level data in RWE submission will be addressed. |
Date: Tuesday 22nd March 2022
Time: 13:30-15:00 GMT | 09:30-11:00 ET
Speakers: Tae Hyun Jung (U.S. Food and Drug Administration), Tim Weaver (Chronic Disease Research Group), Richard Croy (Astellas), David Nimke (Astellas) and Josephine Wolfram (Astellas)
Who is this event intended for? Statisticians or other professionals with an interest in the use of real world data in the regulatory setting.
What is the benefit of attending? To hear first-hand experience of a successful RWE-based submission from different stakeholder perspectives.
You can now register for this event. Registration fees are as follows:
- Members of PSI = Free of charge
- Non-Members of PSI =Free of charge
To register for the session, please click here.
The FDA Real-World Evidence (RWE) Framework was published in Dec. 2018, shedding some light on how Real-World Data (RWD) can be used to support regulatory decision making. This guidance was greatly welcomed in an environment that focuses on efficiency and innovative trial designs. Yet, three years out, there are not many examples of RWE in practice, especially of situations where RWE is the exclusive source of evidence supporting new drug indications. Recently, tacrolimus was approved for Lung transplantation based solely on RWE and we would like to share our experience with statisticians in the pharmaceutical community.
Three stakeholders – the sponsor, RWD vendor and FDA - will share their experiences of the submission and approval process. Topics to be covered include relevant project background & context, identification/selection of RWD, study design & key analysis methods, operational considerations related to study conduct & quality, submission content and labeling.
|
Speakers |
Biographies |
Abstract |
|
|
Rick has been working in clinical development as a statistician in the pharmaceutical industry for over 20 years. For more than 10 of those years, he has been a global statistical lead on various projects, including tacrolimus for transplantation. David is the Real World Evidence-US Lead at Astellas Advanced Informatics and Analytics. His team of observational researchers and analysts conduct research using secondary use databases. Previously, he worked in epidemiology and RWE groups at Astellas, AbbVie, and Abbott Laboratories. David holds a Doctor of Public Health from University of North Carolina. Josie joined the pharmaceutical industry 25 years ago. Following a few years at GSK, she joined Fujisawa in Munich then Astellas in the Netherlands in various statistical roles. She currently leads a small team focused on leveraging real world data to support development projects. |
Richard Croy, David Nimke and Josephine Wolfram will share the background and rationale to pursue this submission, the approach, and key discussion points with the FDA leading up to the submission and during review. Considerations for the choice of RWE and Real-World Data (RWD) used in the pivotal RWD study will be discussed along with the study design elements, key results and challenges. Operational considerations for study conduct and submission will also be addressed |
|
|
Tim Weaver works as a biostatistician in the area of organ transplantation with the Chronic Disease Research Group. In that role he has conducted research using the SRTR database as well as simulation analysis of the organ allocation system. |
Tim Weaver will discuss the source of the RWD, the Scientific Registry of Transplant Recipients database, and the observational nature of the data with its implications for the study design and considerations for analysis. Technical aspects of the data-processing code development, data transfer, and results submission will also be discussed. |
|
|
Tae Hyun Jung, Ph.D., is a Senior Statistical Reviewer in FDA/CDER/OTS/OB/DBVII. He has comprehensive NDA/BLA/PMR review experience from phase III/phase IV safety focused reviews, and phase III efficacy reviews including RWE efficacy. He is also leading multiple RWE/RWD research projects using machine learning/artificial intelligence, evidence synthesis, data quality, and synthetic data. Tae Hyun completed his PhD degree in Biostatistics at Yale University. |
Tae Hyun Jung will share FDA review perspectives and challenges during the review process. Also, the importance of getting quality patient-level data in RWE submission will be addressed. |
Date: Tuesday 22nd March 2022
Time: 13:30-15:00 GMT | 09:30-11:00 ET
Speakers: Tae Hyun Jung (U.S. Food and Drug Administration), Tim Weaver (Chronic Disease Research Group), Richard Croy (Astellas), David Nimke (Astellas) and Josephine Wolfram (Astellas)
Who is this event intended for? Statisticians or other professionals with an interest in the use of real world data in the regulatory setting.
What is the benefit of attending? To hear first-hand experience of a successful RWE-based submission from different stakeholder perspectives.
You can now register for this event. Registration fees are as follows:
- Members of PSI = Free of charge
- Non-Members of PSI =Free of charge
To register for the session, please click here.
The FDA Real-World Evidence (RWE) Framework was published in Dec. 2018, shedding some light on how Real-World Data (RWD) can be used to support regulatory decision making. This guidance was greatly welcomed in an environment that focuses on efficiency and innovative trial designs. Yet, three years out, there are not many examples of RWE in practice, especially of situations where RWE is the exclusive source of evidence supporting new drug indications. Recently, tacrolimus was approved for Lung transplantation based solely on RWE and we would like to share our experience with statisticians in the pharmaceutical community.
Three stakeholders – the sponsor, RWD vendor and FDA - will share their experiences of the submission and approval process. Topics to be covered include relevant project background & context, identification/selection of RWD, study design & key analysis methods, operational considerations related to study conduct & quality, submission content and labeling.
|
Speakers |
Biographies |
Abstract |
|
|
Rick has been working in clinical development as a statistician in the pharmaceutical industry for over 20 years. For more than 10 of those years, he has been a global statistical lead on various projects, including tacrolimus for transplantation. David is the Real World Evidence-US Lead at Astellas Advanced Informatics and Analytics. His team of observational researchers and analysts conduct research using secondary use databases. Previously, he worked in epidemiology and RWE groups at Astellas, AbbVie, and Abbott Laboratories. David holds a Doctor of Public Health from University of North Carolina. Josie joined the pharmaceutical industry 25 years ago. Following a few years at GSK, she joined Fujisawa in Munich then Astellas in the Netherlands in various statistical roles. She currently leads a small team focused on leveraging real world data to support development projects. |
Richard Croy, David Nimke and Josephine Wolfram will share the background and rationale to pursue this submission, the approach, and key discussion points with the FDA leading up to the submission and during review. Considerations for the choice of RWE and Real-World Data (RWD) used in the pivotal RWD study will be discussed along with the study design elements, key results and challenges. Operational considerations for study conduct and submission will also be addressed |
|
|
Tim Weaver works as a biostatistician in the area of organ transplantation with the Chronic Disease Research Group. In that role he has conducted research using the SRTR database as well as simulation analysis of the organ allocation system. |
Tim Weaver will discuss the source of the RWD, the Scientific Registry of Transplant Recipients database, and the observational nature of the data with its implications for the study design and considerations for analysis. Technical aspects of the data-processing code development, data transfer, and results submission will also be discussed. |
|
|
Tae Hyun Jung, Ph.D., is a Senior Statistical Reviewer in FDA/CDER/OTS/OB/DBVII. He has comprehensive NDA/BLA/PMR review experience from phase III/phase IV safety focused reviews, and phase III efficacy reviews including RWE efficacy. He is also leading multiple RWE/RWD research projects using machine learning/artificial intelligence, evidence synthesis, data quality, and synthetic data. Tae Hyun completed his PhD degree in Biostatistics at Yale University. |
Tae Hyun Jung will share FDA review perspectives and challenges during the review process. Also, the importance of getting quality patient-level data in RWE submission will be addressed. |
Date: Tuesday 22nd March 2022
Time: 13:30-15:00 GMT | 09:30-11:00 ET
Speakers: Tae Hyun Jung (U.S. Food and Drug Administration), Tim Weaver (Chronic Disease Research Group), Richard Croy (Astellas), David Nimke (Astellas) and Josephine Wolfram (Astellas)
Who is this event intended for? Statisticians or other professionals with an interest in the use of real world data in the regulatory setting.
What is the benefit of attending? To hear first-hand experience of a successful RWE-based submission from different stakeholder perspectives.
You can now register for this event. Registration fees are as follows:
- Members of PSI = Free of charge
- Non-Members of PSI =Free of charge
To register for the session, please click here.
The FDA Real-World Evidence (RWE) Framework was published in Dec. 2018, shedding some light on how Real-World Data (RWD) can be used to support regulatory decision making. This guidance was greatly welcomed in an environment that focuses on efficiency and innovative trial designs. Yet, three years out, there are not many examples of RWE in practice, especially of situations where RWE is the exclusive source of evidence supporting new drug indications. Recently, tacrolimus was approved for Lung transplantation based solely on RWE and we would like to share our experience with statisticians in the pharmaceutical community.
Three stakeholders – the sponsor, RWD vendor and FDA - will share their experiences of the submission and approval process. Topics to be covered include relevant project background & context, identification/selection of RWD, study design & key analysis methods, operational considerations related to study conduct & quality, submission content and labeling.
|
Speakers |
Biographies |
Abstract |
|
|
Rick has been working in clinical development as a statistician in the pharmaceutical industry for over 20 years. For more than 10 of those years, he has been a global statistical lead on various projects, including tacrolimus for transplantation. David is the Real World Evidence-US Lead at Astellas Advanced Informatics and Analytics. His team of observational researchers and analysts conduct research using secondary use databases. Previously, he worked in epidemiology and RWE groups at Astellas, AbbVie, and Abbott Laboratories. David holds a Doctor of Public Health from University of North Carolina. Josie joined the pharmaceutical industry 25 years ago. Following a few years at GSK, she joined Fujisawa in Munich then Astellas in the Netherlands in various statistical roles. She currently leads a small team focused on leveraging real world data to support development projects. |
Richard Croy, David Nimke and Josephine Wolfram will share the background and rationale to pursue this submission, the approach, and key discussion points with the FDA leading up to the submission and during review. Considerations for the choice of RWE and Real-World Data (RWD) used in the pivotal RWD study will be discussed along with the study design elements, key results and challenges. Operational considerations for study conduct and submission will also be addressed |
|
|
Tim Weaver works as a biostatistician in the area of organ transplantation with the Chronic Disease Research Group. In that role he has conducted research using the SRTR database as well as simulation analysis of the organ allocation system. |
Tim Weaver will discuss the source of the RWD, the Scientific Registry of Transplant Recipients database, and the observational nature of the data with its implications for the study design and considerations for analysis. Technical aspects of the data-processing code development, data transfer, and results submission will also be discussed. |
|
|
Tae Hyun Jung, Ph.D., is a Senior Statistical Reviewer in FDA/CDER/OTS/OB/DBVII. He has comprehensive NDA/BLA/PMR review experience from phase III/phase IV safety focused reviews, and phase III efficacy reviews including RWE efficacy. He is also leading multiple RWE/RWD research projects using machine learning/artificial intelligence, evidence synthesis, data quality, and synthetic data. Tae Hyun completed his PhD degree in Biostatistics at Yale University. |
Tae Hyun Jung will share FDA review perspectives and challenges during the review process. Also, the importance of getting quality patient-level data in RWE submission will be addressed. |
Date: Tuesday 22nd March 2022
Time: 13:30-15:00 GMT | 09:30-11:00 ET
Speakers: Tae Hyun Jung (U.S. Food and Drug Administration), Tim Weaver (Chronic Disease Research Group), Richard Croy (Astellas), David Nimke (Astellas) and Josephine Wolfram (Astellas)
Who is this event intended for? Statisticians or other professionals with an interest in the use of real world data in the regulatory setting.
What is the benefit of attending? To hear first-hand experience of a successful RWE-based submission from different stakeholder perspectives.
You can now register for this event. Registration fees are as follows:
- Members of PSI = Free of charge
- Non-Members of PSI =Free of charge
To register for the session, please click here.
The FDA Real-World Evidence (RWE) Framework was published in Dec. 2018, shedding some light on how Real-World Data (RWD) can be used to support regulatory decision making. This guidance was greatly welcomed in an environment that focuses on efficiency and innovative trial designs. Yet, three years out, there are not many examples of RWE in practice, especially of situations where RWE is the exclusive source of evidence supporting new drug indications. Recently, tacrolimus was approved for Lung transplantation based solely on RWE and we would like to share our experience with statisticians in the pharmaceutical community.
Three stakeholders – the sponsor, RWD vendor and FDA - will share their experiences of the submission and approval process. Topics to be covered include relevant project background & context, identification/selection of RWD, study design & key analysis methods, operational considerations related to study conduct & quality, submission content and labeling.
|
Speakers |
Biographies |
Abstract |
|
|
Rick has been working in clinical development as a statistician in the pharmaceutical industry for over 20 years. For more than 10 of those years, he has been a global statistical lead on various projects, including tacrolimus for transplantation. David is the Real World Evidence-US Lead at Astellas Advanced Informatics and Analytics. His team of observational researchers and analysts conduct research using secondary use databases. Previously, he worked in epidemiology and RWE groups at Astellas, AbbVie, and Abbott Laboratories. David holds a Doctor of Public Health from University of North Carolina. Josie joined the pharmaceutical industry 25 years ago. Following a few years at GSK, she joined Fujisawa in Munich then Astellas in the Netherlands in various statistical roles. She currently leads a small team focused on leveraging real world data to support development projects. |
Richard Croy, David Nimke and Josephine Wolfram will share the background and rationale to pursue this submission, the approach, and key discussion points with the FDA leading up to the submission and during review. Considerations for the choice of RWE and Real-World Data (RWD) used in the pivotal RWD study will be discussed along with the study design elements, key results and challenges. Operational considerations for study conduct and submission will also be addressed |
|
|
Tim Weaver works as a biostatistician in the area of organ transplantation with the Chronic Disease Research Group. In that role he has conducted research using the SRTR database as well as simulation analysis of the organ allocation system. |
Tim Weaver will discuss the source of the RWD, the Scientific Registry of Transplant Recipients database, and the observational nature of the data with its implications for the study design and considerations for analysis. Technical aspects of the data-processing code development, data transfer, and results submission will also be discussed. |
|
|
Tae Hyun Jung, Ph.D., is a Senior Statistical Reviewer in FDA/CDER/OTS/OB/DBVII. He has comprehensive NDA/BLA/PMR review experience from phase III/phase IV safety focused reviews, and phase III efficacy reviews including RWE efficacy. He is also leading multiple RWE/RWD research projects using machine learning/artificial intelligence, evidence synthesis, data quality, and synthetic data. Tae Hyun completed his PhD degree in Biostatistics at Yale University. |
Tae Hyun Jung will share FDA review perspectives and challenges during the review process. Also, the importance of getting quality patient-level data in RWE submission will be addressed. |
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.
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.
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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