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Risk management

Risk/benefit analysis

Risk/benefit analysis underpins many of the services that Pope Woodhead provides. Our free-thinking consultancy support and flexible toolkit of methodologies can be applied to solve a variety of the challenges faced by the pharma industry today.

We offer:

Risk assessment
Risk/benefit analysis in the context of the treatment pathway
Comparative risk/benefit profiling
Portfolio risk/benefit assessment
Support in implementing ICH Q9 quality risk management guidance
Risk/benefit analysis to demonstrate value and consequently aid reimbursement.

Recent projects:

Comprehensive risk assessment for a biological, which determined and justified the risk minimisation activities for a US Risk Evaluation and Mitigation Strategy (REMS)
Mapping of potential safety hazards within healthcare systems for a new cardiovascular drug, and subsequent design of approaches and tools to overcome them
Comparative risk/benefit analysis of marketed and pipeline competitors to a first-in-class CNS drug
Evaluation of the best approach to navigate a biosimilar regulatory pathway
Analysis of value drivers and associated challenges for a first-in-class cardiovascular drug that supported its pricing and reimbursement strategy.

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