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.
Joint PSI, EFSPI & ASA BIOP Webinar: Estimands
PSI, the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) and the Biopharmaceutical Section of the American Statistical Association (ASA) are jointly organising a webinar on Estimands in Practice. Speakers from regulatory authorities (FDA and EMA) and industry will present on their experience on this topic to date.
Discover your potential by working as a Covance Senior Principal / Principal Biostatistician. You'll enjoy a varied role working for different sponsors across several therapeutic areas, leading projects and mentoring junior members of the department.
Biometrics at AstraZeneca provides the data that influences decisions on how we roll back the frontiers of science to bring life-changing medicines to the world. We are at the heart of design, analytics and interpretation of AstraZeneca’s portfolio.