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 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.
The BioMarin internship programme will enable students to gain valuable experience and knowledge of the processes and systems within BioMarin, whilst gaining an insight into the pharmaceutical/biotech industry.