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Pharmacovigilance and Risk Management Strategies Conference

NEW! The 2019 meeting will be a full three days, allowing maximum learning opportunities!

Session 13: Aspects of Benefit-Risk Assessments

Session Chair(s)

Stella  Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP

Stella Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP

  • Senior Advisor Regulatory Science
  • NEWDIGS at Massachusetts Institute of Technology, United Kingdom
Benefit versus risk assessment is an essential part of the decision making regarding theauthorization, prescribing and taking of medicines. Many stakeholders make decisions based on estimates of the benefit risk balance. These estimates vary from the population based decisions made by regulators and pharmaceutical companies to estimates at the individual level made by doctors and patients. This session will look at 3 different aspects of benefit risk assessment: benefit risk for regulatory decision making; a practical example of how to do benefit risk estimations for a well-established medicine and finally on patient preferences and how to communicate risk to patients.
Learning Objective : Upon completion of this session, the participant should be able to:
  • Understand how benefit risk assessment can be used in regulatory decision making
  • Understand how to do a benefit risk analysis for a well-established medicine
  • Understand patient preferences and communication of risk to patients including IMI-Prefer


    Deborah  Ashby, PhD, MSc

    Better Benefit-Risk Decision-Making in the Regulation of Medicines

    Deborah Ashby, PhD, MSc

    • Professor of Medical Statistics and Clinical Trials
    • Imperial College London, United Kingdom
    Rosa  Piccirillo, MD

    Benefit-Risk Assessment (BRA): An Illustrative Case Study

    Rosa Piccirillo, MD

    • VP and Global Head, Medical Safety, Core Safety Services
    • IQVIA, United States