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
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.
Topic: R Package Basics.
Our monthly webinar series allows attendees to gain practical knowledge and skills in open-source coding and tools, with a focus on applications in the pharmaceutical industry. This month’s session, “R Package Basics,” will introduce the fundamentals of working with R packages—covering how to install, load, and manage them effectively to support data analysis and reproducible research. The session will provide a solid starting point, clarify common misconceptions, and offer valuable resources for continued learning.
Date: Ongoing 6 month cycle beginning late April/early May 2026
Are you a member of PSI looking to further your career or help develop others - why not sign up to the PSI Mentoring scheme? You can expand your network, improve your leadership skills and learn from more senior colleagues in the industry.
PSI Book Club Lunch and Learn: Communicating with Clarity and Confidence
If you have read Ros Atkins’ book The Art of Explanation or want to listen to the BBC’s ‘Communicator in Chief’, you are invited to join the PSI Book Club Lunch and Learn, to discuss the content and application with the author, Ros Atkins. Having written the book within the context of the news industry, Ros is keen to hear how we have applied the ideas as statisticians within drug development and clinical trials. There will be dedicated time during the webinar to ASK THE AUTHOR any questions – don’t miss out on this exclusive PSI Book Club event!
Haven’t read the book yet? Pick up a copy today and join us.
Explanation - identifying and communicating what we want to say - is described as an art, in the title of his book. However, the creativity comes from Ros’ discernment in identifying and describing a clear step-by-step process to follow and practice. Readers can learn Ros’ rules, developed and polished throughout his career as a journalist, to help communicate complex written or spoken information clearly.
PSI Training Course: Effective Leadership – the keys to growing your leadership capabilities
This course will consist of three online half-day workshops. The first will be aimed at building trust, the backbone of leadership and a key to becoming effective. This is key to building a solid foundation.
The second will be on improving communication as a technical leader. This workshop will focus on communication strategies for different stakeholders and will involve tips on effective communication and how to develop the skills of active listening, coaching and what improv can teach us about good communication.
The final workshop will bring these two components together to help leaders become more influential. This will also focus on how to use Steven Covey’s 7-Habits, in particular Habits 4, 5 and 6, which are called the habits of communication.
The workshops will be interactive, allowing you to practice the concepts discussed. There will be plenty of time for questions and discussion. There will also be reflective time where you can think about what you are learning and how you might experiment with it.