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
Examples
Review of EU risk management strategy during Marketing Authorization Application (MAA)
Evaluation of product of benefits/risks and competitors’ comparison
Facilitation of internal discussions and support of decision-making
Membership in ad-hoc and regular Safety Advisory Boards
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
