The aim of this workshop is to provide participants an understanding of structured benefit-risk assessments, and the regulatory requirements on benefit-risk assessment within the EU. The 2 day course includes a practical workshop whereby participants will critically evaluate the benefit-risk balance of medicinal and healthcare product(s) in a robust and transparent manner. The course will provide participants the opportunity to gain insight and develop modelling skills in benefit-risk assessment, with an emphasis on multi-criteria decision analysis.
The involvement of multiple stakeholders in a BR assessment
BR assessment in regulatory submissions
Quantitative modelling in BR assessment
Modelling benefit-risk balance and uncertainty involving multiple stakeholders
Application and issues of BR assessment in health technology assessments
Lecturers taken from academia and industry with an involvement in the IMI PROTECT Initiative on Benefit-Risk Assessment and industry group’sown initiatives.
Keynote speakers include Prof Deborah Ashby (Imperial College) and Prof Larry Phillips (London School of Economics).
Course runs from:
12:00 – 18.30 (registration from 10:00) on Day 1 and
09:00 – 16:30 on Day 2.
Registration
PSI Members
£495 plus VAT
Non - members
£570 plus VAT (includes PSI membership for 1 year)
Academic
£295 plus VAT
Registration costs (includes lunch and refreshments) Registration for this 2 day course is now closed.
PSI aims to be fully inclusive and endeavours to accommodate delegates with disabilities wherever possible. Please help us to help you by letting us know if you require additional facilities or have any special requirements. Please contact us on +44 (0)1730 715 235 or at PSI@mci-group.com for further information.
Scientific Meetings
Structured Benefit-Risk Assessment – Methodology and Practice
The aim of this workshop is to provide participants an understanding of structured benefit-risk assessments, and the regulatory requirements on benefit-risk assessment within the EU. The 2 day course includes a practical workshop whereby participants will critically evaluate the benefit-risk balance of medicinal and healthcare product(s) in a robust and transparent manner. The course will provide participants the opportunity to gain insight and develop modelling skills in benefit-risk assessment, with an emphasis on multi-criteria decision analysis.
The involvement of multiple stakeholders in a BR assessment
BR assessment in regulatory submissions
Quantitative modelling in BR assessment
Modelling benefit-risk balance and uncertainty involving multiple stakeholders
Application and issues of BR assessment in health technology assessments
Lecturers taken from academia and industry with an involvement in the IMI PROTECT Initiative on Benefit-Risk Assessment and industry group’sown initiatives.
Keynote speakers include Prof Deborah Ashby (Imperial College) and Prof Larry Phillips (London School of Economics).
Course runs from:
12:00 – 18.30 (registration from 10:00) on Day 1 and
09:00 – 16:30 on Day 2.
Registration
PSI Members
£495 plus VAT
Non - members
£570 plus VAT (includes PSI membership for 1 year)
Academic
£295 plus VAT
Registration costs (includes lunch and refreshments) Registration for this 2 day course is now closed.
PSI aims to be fully inclusive and endeavours to accommodate delegates with disabilities wherever possible. Please help us to help you by letting us know if you require additional facilities or have any special requirements. Please contact us on +44 (0)1730 715 235 or at PSI@mci-group.com for further information.
Training Courses
Structured Benefit-Risk Assessment – Methodology and Practice
The aim of this workshop is to provide participants an understanding of structured benefit-risk assessments, and the regulatory requirements on benefit-risk assessment within the EU. The 2 day course includes a practical workshop whereby participants will critically evaluate the benefit-risk balance of medicinal and healthcare product(s) in a robust and transparent manner. The course will provide participants the opportunity to gain insight and develop modelling skills in benefit-risk assessment, with an emphasis on multi-criteria decision analysis.
The involvement of multiple stakeholders in a BR assessment
BR assessment in regulatory submissions
Quantitative modelling in BR assessment
Modelling benefit-risk balance and uncertainty involving multiple stakeholders
Application and issues of BR assessment in health technology assessments
Lecturers taken from academia and industry with an involvement in the IMI PROTECT Initiative on Benefit-Risk Assessment and industry group’sown initiatives.
Keynote speakers include Prof Deborah Ashby (Imperial College) and Prof Larry Phillips (London School of Economics).
Course runs from:
12:00 – 18.30 (registration from 10:00) on Day 1 and
09:00 – 16:30 on Day 2.
Registration
PSI Members
£495 plus VAT
Non - members
£570 plus VAT (includes PSI membership for 1 year)
Academic
£295 plus VAT
Registration costs (includes lunch and refreshments) Registration for this 2 day course is now closed.
PSI aims to be fully inclusive and endeavours to accommodate delegates with disabilities wherever possible. Please help us to help you by letting us know if you require additional facilities or have any special requirements. Please contact us on +44 (0)1730 715 235 or at PSI@mci-group.com for further information.
Journal Club
Structured Benefit-Risk Assessment – Methodology and Practice
The aim of this workshop is to provide participants an understanding of structured benefit-risk assessments, and the regulatory requirements on benefit-risk assessment within the EU. The 2 day course includes a practical workshop whereby participants will critically evaluate the benefit-risk balance of medicinal and healthcare product(s) in a robust and transparent manner. The course will provide participants the opportunity to gain insight and develop modelling skills in benefit-risk assessment, with an emphasis on multi-criteria decision analysis.
The involvement of multiple stakeholders in a BR assessment
BR assessment in regulatory submissions
Quantitative modelling in BR assessment
Modelling benefit-risk balance and uncertainty involving multiple stakeholders
Application and issues of BR assessment in health technology assessments
Lecturers taken from academia and industry with an involvement in the IMI PROTECT Initiative on Benefit-Risk Assessment and industry group’sown initiatives.
Keynote speakers include Prof Deborah Ashby (Imperial College) and Prof Larry Phillips (London School of Economics).
Course runs from:
12:00 – 18.30 (registration from 10:00) on Day 1 and
09:00 – 16:30 on Day 2.
Registration
PSI Members
£495 plus VAT
Non - members
£570 plus VAT (includes PSI membership for 1 year)
Academic
£295 plus VAT
Registration costs (includes lunch and refreshments) Registration for this 2 day course is now closed.
PSI aims to be fully inclusive and endeavours to accommodate delegates with disabilities wherever possible. Please help us to help you by letting us know if you require additional facilities or have any special requirements. Please contact us on +44 (0)1730 715 235 or at PSI@mci-group.com for further information.
Webinars
Structured Benefit-Risk Assessment – Methodology and Practice
The aim of this workshop is to provide participants an understanding of structured benefit-risk assessments, and the regulatory requirements on benefit-risk assessment within the EU. The 2 day course includes a practical workshop whereby participants will critically evaluate the benefit-risk balance of medicinal and healthcare product(s) in a robust and transparent manner. The course will provide participants the opportunity to gain insight and develop modelling skills in benefit-risk assessment, with an emphasis on multi-criteria decision analysis.
The involvement of multiple stakeholders in a BR assessment
BR assessment in regulatory submissions
Quantitative modelling in BR assessment
Modelling benefit-risk balance and uncertainty involving multiple stakeholders
Application and issues of BR assessment in health technology assessments
Lecturers taken from academia and industry with an involvement in the IMI PROTECT Initiative on Benefit-Risk Assessment and industry group’sown initiatives.
Keynote speakers include Prof Deborah Ashby (Imperial College) and Prof Larry Phillips (London School of Economics).
Course runs from:
12:00 – 18.30 (registration from 10:00) on Day 1 and
09:00 – 16:30 on Day 2.
Registration
PSI Members
£495 plus VAT
Non - members
£570 plus VAT (includes PSI membership for 1 year)
Academic
£295 plus VAT
Registration costs (includes lunch and refreshments) Registration for this 2 day course is now closed.
PSI aims to be fully inclusive and endeavours to accommodate delegates with disabilities wherever possible. Please help us to help you by letting us know if you require additional facilities or have any special requirements. Please contact us on +44 (0)1730 715 235 or at PSI@mci-group.com for further information.
Careers Meetings
Structured Benefit-Risk Assessment – Methodology and Practice
The aim of this workshop is to provide participants an understanding of structured benefit-risk assessments, and the regulatory requirements on benefit-risk assessment within the EU. The 2 day course includes a practical workshop whereby participants will critically evaluate the benefit-risk balance of medicinal and healthcare product(s) in a robust and transparent manner. The course will provide participants the opportunity to gain insight and develop modelling skills in benefit-risk assessment, with an emphasis on multi-criteria decision analysis.
The involvement of multiple stakeholders in a BR assessment
BR assessment in regulatory submissions
Quantitative modelling in BR assessment
Modelling benefit-risk balance and uncertainty involving multiple stakeholders
Application and issues of BR assessment in health technology assessments
Lecturers taken from academia and industry with an involvement in the IMI PROTECT Initiative on Benefit-Risk Assessment and industry group’sown initiatives.
Keynote speakers include Prof Deborah Ashby (Imperial College) and Prof Larry Phillips (London School of Economics).
Course runs from:
12:00 – 18.30 (registration from 10:00) on Day 1 and
09:00 – 16:30 on Day 2.
Registration
PSI Members
£495 plus VAT
Non - members
£570 plus VAT (includes PSI membership for 1 year)
Academic
£295 plus VAT
Registration costs (includes lunch and refreshments) Registration for this 2 day course is now closed.
PSI aims to be fully inclusive and endeavours to accommodate delegates with disabilities wherever possible. Please help us to help you by letting us know if you require additional facilities or have any special requirements. Please contact us on +44 (0)1730 715 235 or at PSI@mci-group.com for further information.
Upcoming Events
PSI Training Course: Introduction to Machine Learning
This course is aimed at clinical trial statisticians who are new to or with limited experience of machine learning. Attendees will learn about a range of topics in machine learning, including practical sessions in R.
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.
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