Benefit / Risk Evaluations

The assessment of product-specific benefits and risks requires information about the context: the therapeutic indication, patient characteristics, application of the medicinal product and alternate treatment options.

Key Deliverables

  • Product-specific safety planning
  • Pharmacovigilance and risk management systems
  • Failure modes and effects analysis (FMEA)
  • Risk Minimization strategies and effectiveness
  • Management of safety concerns
  • Design and implementation of post-authorization safety studies, conduct of feasibility studies
  • Support of interaction with regulatory agencies


  1. Review of EU risk management strategy during Marketing Authorization Application (MAA)
  2. Evaluation of product of benefits/risks and competitors’ comparison
  3. Facilitation of internal discussions and support of decision-making
  4. Membership in ad-hoc and regular Safety Advisory Boards
  5. Development of Risk Management Plans for established and innovative therapies

Methodological Aspects

  • The Benefit Risk Assessment Team (BRAT) is a framework well suited to benefit-risk analysis
  • Benefit-risk analysis is conceptually easy but hard to operationalize - in particular:
    • To define consistent criteria across decision options, find data matching these criteria
      and elicit value judgements
  • A BR assessment does not necessarily give the answer
    • It is a framework for decomposing and understanding a problem
    • Assesses the main value drivers of a decision
    • Communicates issues in a transparent, rational and consistent way
    • Allows sensitivity analysis around different perspectives