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.
The event will open with an overview on drug development in women’s health from a clinician perspective. This talk is followed by talks about statistical challenges when planning IVF studies and analysing the menstrual cycles.
This webinar will provide an overview of surrogacy for licensing and reimbursement. In turn, the need of extensions of the SPIRIT and CONSORT statement will be defined and outlined, with case studies to support.
Joint PSI/EFSPI Pre-Clinical SIG Webinar: Virtual Control Groups in Toxicity Studies
Lea Vaas will present how replacement of concurrent control animals by Virtual Control Groups (VCGs) in systemic toxicity studies may help in contributing to the 3R's principle of animal experimentation: Reduce, Refine, Replace.
Joint PSI/EFSPI Data Science SIG Webinar: Developing Digital Measures (Digital Biomarkers) in Drug Development – insights from Mobilise D consortium
We will share a brief overview of what Mobilise D is and why it is an important step stone in the development of digital biomarkers, and how Mobilise D outputs can be relevant for you.
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: Development of Gene Therapies: Strategic, Scientific, Regulatory and Access Considerations
This webinar will cover the history of cell/gene therapy, major regulatory advances, the role of quantitative scientists in drug development of these novel therapeutics, and discuss opportunities for innovation and product advancement.
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 Introduction to Industry Training (ITIT) Course - 2024/2025
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.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
Statisticians in the Pharmaceutical Industry Executive Office: c/o MCI UK Ltd | Unit 24/22 South | Building 4000 | Langstone Park| Langstone Road | Havant | PO9 1SA | UK