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.
£495 plus VAT
Non - members
£570 plus VAT (includes PSI membership for 1 year)
£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.
PSI EIWG Webinar: PIONEERing estimands in Clinical Research (Session 2)
Bringing estimands to life through a real case study. Members of the estimands Implementation Working Group (EIWG) will describe the background and study objectives, intercurrent events of interest and chosen estimands in the PIONEER study.
Our annual PSI Medical Statistics Careers Event, will be held online using the Career Fair Plus app on Wednesday 3rd March 2021. The event will include a live online panel discussion and a virtual exhibition session.
Discover your extraordinary potential by working as a Covance AD, Biostatistics / Senior Principal Biostatistician. You will consult in the design of complex and innovative studies & clinical trial programs as well as Leading DMC/DSMB processes.
By joining our company, in this role you will apply your skills and experience in support of developing scientifically based arguments aiming to provide fair accessibility to our company’s drugs and vaccines making a real difference in patient’s lives.
Senior Principal / Principal Biostatistician (Oncology) – FSP
Join our team as a Covance FSP Senior Principal or Principal Biostatistician. You will be assigned to one Sponsor working on Phase I and II oncology studies. Previous Lead experience essential. Office or home-based anywhere in Europe or South Africa.