Date: Tuesday 8th - Thursday 10th June 2021 Time:8th 09:00-13:00 || 9th 14:30-16:30 || 10th 09:00-13:00 BST Presenters: Andy Grieve, James Matcham, Julia Saperia, Thomas Jaki & David Kerr
Who is this event intended for? This training course is suitable for statisticians working on clinical trials which require a DMC. What is the benefit of attending? Understand the different roles and responsibilities within a DMC, and have the chance to participate in a DMC within an interactive workshop.
Course cost
NB: This course has Earlybird rates available. These are valid for bookings on or before 14th May only. Earlybird Members = £250+VAT Earlybird Non-Members = £345+VAT* Regular Members = £290+VAT Regular Non-Members = £385+VAT*
*Please note: Non-Member rates include membership for the rest of the 2021 calendar year.
Registration
This course is now available to book. To register your place, please click here. Please note: Places for this course are limited and in high-demand, so please ensure you are able to attend all sessions before booking.
Overview
Data Monitoring Committees (DMCs) (also known as Data and Safety Monitoring Boards, DSMBs) are responsible for the review of accumulating data from ongoing clinical trials. The DMC will advise the trial sponsor regarding the continuing safety of trial subjects and those yet to be recruited to the trial, as well as the continuing validity and scientific merit of the trial (FDA Guidance for Clinical Trial Sponsor - Establishment and Operation of Clinical Trial Data Monitoring Committees). DMCs can also be used to analyse unblinded data for studies with group sequential design and other adaptive design elements to reduce potential operational bias.
Topics covered include:
• Introduction to DMCs
- Responsibilities within a DMC
- DMC charter
- Practical considerations
- Statistical monitoring methods
• DMC case studies
• Interactive DMC workshop
• Perspectives from the Independent Statistician
• Importance and expectations of a DMC from a regulatory perspective
• The new role of DMCs in adaptive designs and platform studies
• Experiences of DMCs during the pandemic
Please click here to view the flyer for this event.
Cancellation and Moderation Terms For cancellations received up to two weeks prior to a PSI event start-date, the event registration fee will be refunded less 25% administrative charge. After this date, no refunds will be possible. A handling fee of 20 GBP per registration will be charged for every registration modification received two weeks prior or less, including a delegate name change.
Scientific Meetings
PSI Training Course: Data Monitoring Committees (DMCs)
Date: Tuesday 8th - Thursday 10th June 2021 Time:8th 09:00-13:00 || 9th 14:30-16:30 || 10th 09:00-13:00 BST Presenters: Andy Grieve, James Matcham, Julia Saperia, Thomas Jaki & David Kerr
Who is this event intended for? This training course is suitable for statisticians working on clinical trials which require a DMC. What is the benefit of attending? Understand the different roles and responsibilities within a DMC, and have the chance to participate in a DMC within an interactive workshop.
Course cost
NB: This course has Earlybird rates available. These are valid for bookings on or before 14th May only. Earlybird Members = £250+VAT Earlybird Non-Members = £345+VAT* Regular Members = £290+VAT Regular Non-Members = £385+VAT*
*Please note: Non-Member rates include membership for the rest of the 2021 calendar year.
Registration
This course is now available to book. To register your place, please click here. Please note: Places for this course are limited and in high-demand, so please ensure you are able to attend all sessions before booking.
Overview
Data Monitoring Committees (DMCs) (also known as Data and Safety Monitoring Boards, DSMBs) are responsible for the review of accumulating data from ongoing clinical trials. The DMC will advise the trial sponsor regarding the continuing safety of trial subjects and those yet to be recruited to the trial, as well as the continuing validity and scientific merit of the trial (FDA Guidance for Clinical Trial Sponsor - Establishment and Operation of Clinical Trial Data Monitoring Committees). DMCs can also be used to analyse unblinded data for studies with group sequential design and other adaptive design elements to reduce potential operational bias.
Topics covered include:
• Introduction to DMCs
- Responsibilities within a DMC
- DMC charter
- Practical considerations
- Statistical monitoring methods
• DMC case studies
• Interactive DMC workshop
• Perspectives from the Independent Statistician
• Importance and expectations of a DMC from a regulatory perspective
• The new role of DMCs in adaptive designs and platform studies
• Experiences of DMCs during the pandemic
Please click here to view the flyer for this event.
Cancellation and Moderation Terms For cancellations received up to two weeks prior to a PSI event start-date, the event registration fee will be refunded less 25% administrative charge. After this date, no refunds will be possible. A handling fee of 20 GBP per registration will be charged for every registration modification received two weeks prior or less, including a delegate name change.
Training Courses
PSI Training Course: Data Monitoring Committees (DMCs)
Date: Tuesday 8th - Thursday 10th June 2021 Time:8th 09:00-13:00 || 9th 14:30-16:30 || 10th 09:00-13:00 BST Presenters: Andy Grieve, James Matcham, Julia Saperia, Thomas Jaki & David Kerr
Who is this event intended for? This training course is suitable for statisticians working on clinical trials which require a DMC. What is the benefit of attending? Understand the different roles and responsibilities within a DMC, and have the chance to participate in a DMC within an interactive workshop.
Course cost
NB: This course has Earlybird rates available. These are valid for bookings on or before 14th May only. Earlybird Members = £250+VAT Earlybird Non-Members = £345+VAT* Regular Members = £290+VAT Regular Non-Members = £385+VAT*
*Please note: Non-Member rates include membership for the rest of the 2021 calendar year.
Registration
This course is now available to book. To register your place, please click here. Please note: Places for this course are limited and in high-demand, so please ensure you are able to attend all sessions before booking.
Overview
Data Monitoring Committees (DMCs) (also known as Data and Safety Monitoring Boards, DSMBs) are responsible for the review of accumulating data from ongoing clinical trials. The DMC will advise the trial sponsor regarding the continuing safety of trial subjects and those yet to be recruited to the trial, as well as the continuing validity and scientific merit of the trial (FDA Guidance for Clinical Trial Sponsor - Establishment and Operation of Clinical Trial Data Monitoring Committees). DMCs can also be used to analyse unblinded data for studies with group sequential design and other adaptive design elements to reduce potential operational bias.
Topics covered include:
• Introduction to DMCs
- Responsibilities within a DMC
- DMC charter
- Practical considerations
- Statistical monitoring methods
• DMC case studies
• Interactive DMC workshop
• Perspectives from the Independent Statistician
• Importance and expectations of a DMC from a regulatory perspective
• The new role of DMCs in adaptive designs and platform studies
• Experiences of DMCs during the pandemic
Please click here to view the flyer for this event.
Cancellation and Moderation Terms For cancellations received up to two weeks prior to a PSI event start-date, the event registration fee will be refunded less 25% administrative charge. After this date, no refunds will be possible. A handling fee of 20 GBP per registration will be charged for every registration modification received two weeks prior or less, including a delegate name change.
Journal Club
PSI Training Course: Data Monitoring Committees (DMCs)
Date: Tuesday 8th - Thursday 10th June 2021 Time:8th 09:00-13:00 || 9th 14:30-16:30 || 10th 09:00-13:00 BST Presenters: Andy Grieve, James Matcham, Julia Saperia, Thomas Jaki & David Kerr
Who is this event intended for? This training course is suitable for statisticians working on clinical trials which require a DMC. What is the benefit of attending? Understand the different roles and responsibilities within a DMC, and have the chance to participate in a DMC within an interactive workshop.
Course cost
NB: This course has Earlybird rates available. These are valid for bookings on or before 14th May only. Earlybird Members = £250+VAT Earlybird Non-Members = £345+VAT* Regular Members = £290+VAT Regular Non-Members = £385+VAT*
*Please note: Non-Member rates include membership for the rest of the 2021 calendar year.
Registration
This course is now available to book. To register your place, please click here. Please note: Places for this course are limited and in high-demand, so please ensure you are able to attend all sessions before booking.
Overview
Data Monitoring Committees (DMCs) (also known as Data and Safety Monitoring Boards, DSMBs) are responsible for the review of accumulating data from ongoing clinical trials. The DMC will advise the trial sponsor regarding the continuing safety of trial subjects and those yet to be recruited to the trial, as well as the continuing validity and scientific merit of the trial (FDA Guidance for Clinical Trial Sponsor - Establishment and Operation of Clinical Trial Data Monitoring Committees). DMCs can also be used to analyse unblinded data for studies with group sequential design and other adaptive design elements to reduce potential operational bias.
Topics covered include:
• Introduction to DMCs
- Responsibilities within a DMC
- DMC charter
- Practical considerations
- Statistical monitoring methods
• DMC case studies
• Interactive DMC workshop
• Perspectives from the Independent Statistician
• Importance and expectations of a DMC from a regulatory perspective
• The new role of DMCs in adaptive designs and platform studies
• Experiences of DMCs during the pandemic
Please click here to view the flyer for this event.
Cancellation and Moderation Terms For cancellations received up to two weeks prior to a PSI event start-date, the event registration fee will be refunded less 25% administrative charge. After this date, no refunds will be possible. A handling fee of 20 GBP per registration will be charged for every registration modification received two weeks prior or less, including a delegate name change.
Webinars
PSI Training Course: Data Monitoring Committees (DMCs)
Date: Tuesday 8th - Thursday 10th June 2021 Time:8th 09:00-13:00 || 9th 14:30-16:30 || 10th 09:00-13:00 BST Presenters: Andy Grieve, James Matcham, Julia Saperia, Thomas Jaki & David Kerr
Who is this event intended for? This training course is suitable for statisticians working on clinical trials which require a DMC. What is the benefit of attending? Understand the different roles and responsibilities within a DMC, and have the chance to participate in a DMC within an interactive workshop.
Course cost
NB: This course has Earlybird rates available. These are valid for bookings on or before 14th May only. Earlybird Members = £250+VAT Earlybird Non-Members = £345+VAT* Regular Members = £290+VAT Regular Non-Members = £385+VAT*
*Please note: Non-Member rates include membership for the rest of the 2021 calendar year.
Registration
This course is now available to book. To register your place, please click here. Please note: Places for this course are limited and in high-demand, so please ensure you are able to attend all sessions before booking.
Overview
Data Monitoring Committees (DMCs) (also known as Data and Safety Monitoring Boards, DSMBs) are responsible for the review of accumulating data from ongoing clinical trials. The DMC will advise the trial sponsor regarding the continuing safety of trial subjects and those yet to be recruited to the trial, as well as the continuing validity and scientific merit of the trial (FDA Guidance for Clinical Trial Sponsor - Establishment and Operation of Clinical Trial Data Monitoring Committees). DMCs can also be used to analyse unblinded data for studies with group sequential design and other adaptive design elements to reduce potential operational bias.
Topics covered include:
• Introduction to DMCs
- Responsibilities within a DMC
- DMC charter
- Practical considerations
- Statistical monitoring methods
• DMC case studies
• Interactive DMC workshop
• Perspectives from the Independent Statistician
• Importance and expectations of a DMC from a regulatory perspective
• The new role of DMCs in adaptive designs and platform studies
• Experiences of DMCs during the pandemic
Please click here to view the flyer for this event.
Cancellation and Moderation Terms For cancellations received up to two weeks prior to a PSI event start-date, the event registration fee will be refunded less 25% administrative charge. After this date, no refunds will be possible. A handling fee of 20 GBP per registration will be charged for every registration modification received two weeks prior or less, including a delegate name change.
Careers Meetings
PSI Training Course: Data Monitoring Committees (DMCs)
Date: Tuesday 8th - Thursday 10th June 2021 Time:8th 09:00-13:00 || 9th 14:30-16:30 || 10th 09:00-13:00 BST Presenters: Andy Grieve, James Matcham, Julia Saperia, Thomas Jaki & David Kerr
Who is this event intended for? This training course is suitable for statisticians working on clinical trials which require a DMC. What is the benefit of attending? Understand the different roles and responsibilities within a DMC, and have the chance to participate in a DMC within an interactive workshop.
Course cost
NB: This course has Earlybird rates available. These are valid for bookings on or before 14th May only. Earlybird Members = £250+VAT Earlybird Non-Members = £345+VAT* Regular Members = £290+VAT Regular Non-Members = £385+VAT*
*Please note: Non-Member rates include membership for the rest of the 2021 calendar year.
Registration
This course is now available to book. To register your place, please click here. Please note: Places for this course are limited and in high-demand, so please ensure you are able to attend all sessions before booking.
Overview
Data Monitoring Committees (DMCs) (also known as Data and Safety Monitoring Boards, DSMBs) are responsible for the review of accumulating data from ongoing clinical trials. The DMC will advise the trial sponsor regarding the continuing safety of trial subjects and those yet to be recruited to the trial, as well as the continuing validity and scientific merit of the trial (FDA Guidance for Clinical Trial Sponsor - Establishment and Operation of Clinical Trial Data Monitoring Committees). DMCs can also be used to analyse unblinded data for studies with group sequential design and other adaptive design elements to reduce potential operational bias.
Topics covered include:
• Introduction to DMCs
- Responsibilities within a DMC
- DMC charter
- Practical considerations
- Statistical monitoring methods
• DMC case studies
• Interactive DMC workshop
• Perspectives from the Independent Statistician
• Importance and expectations of a DMC from a regulatory perspective
• The new role of DMCs in adaptive designs and platform studies
• Experiences of DMCs during the pandemic
Please click here to view the flyer for this event.
Cancellation and Moderation Terms For cancellations received up to two weeks prior to a PSI event start-date, the event registration fee will be refunded less 25% administrative charge. After this date, no refunds will be possible. A handling fee of 20 GBP per registration will be charged for every registration modification received two weeks prior or less, including a delegate name change.
Upcoming Events
PSI Introduction to Industry Training (ITIT) Course - 2025/2026
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.
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 Webinar: Atomic Habits - The Science of Getting Your Act Together
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.
PSI Webinar: Methods and tools integrating clinical trial evidence with historical or real-world data, Bayesian borrowing, and causal inference
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.
PSI Webinar: Applying the Estimand Framework to Clinical Pharmacology Trials with a Case Study in Bioequivalance
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.
PSI Webinar: Methodology and first results of the iRISE (improving Reproducibility In SciencE) consortium
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.
One-day PSI/PHUSE Event: Change Management for Moving to R/Open-Source
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.
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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