Concepts behind quantitative BRA and why quantification is necessary
Requirements of the New EU legislation (GVP) for the New PSUR (Periodic Safety Update Reports)
The role of quantitative models in BRA and regulatory expectations including the current opinion of the European working groups
The process for undertaking BRA and the evidence and data requirements
Principles and practice of statistical BRA including the advantages and disadvantages of the principal methods
Methodological options available and their pro’s and con’s
Case studies and exercises
How to implement/optimise BRA for the new PSUR in your company and what other companies are implementing

Quantitative Benefit-Risk Assessment for the New PSUR 2015

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