Quantitative Benefit-Risk Assessment for the New PSUR 2015

  • 2015
  • Holiday Inn London Bloomsbury, United Kingdom

Description

Quantitative Benefit-Risk Assessment for the New PSUR 2015 is a seminar that covers topics such as:

  • 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

Past Events

Important

Please, check "Quantitative Benefit-Risk Assessment for the New PSUR" official website for possible changes, before making any traveling arrangements

Event Categories

Health & Medicine: Healthcare, Medical device, Pharma

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