Structured Benefit-Risk Assessment – Methodology and Practice

Hilton Garden Inn, Heathrow, UK

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.

Structured Benefit-Risk Assessment – Methodology and Practice - Flyer 
 The following topics will be covered:
  • Regulatory issues surrounding benefit-risk (BR) assessment
  • Planning a structured BR assessment
  • BR assessment methodologies
  • Making the right methodology choices
  • 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.


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.

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