Optimizing Benefit-Risk Assessments for High-Risk Products

Client Challenge
A pharmaceutical company was facing regulatory scrutiny for a high-risk product due to emerging safety concerns. The product’s benefit-risk profile was under review, and the client needed to demonstrate that the therapeutic benefits outweighed the risks to maintain market authorization. The challenge was to conduct a comprehensive and scientifically robust benefit-risk assessment that would satisfy regulatory requirements and reassure stakeholders.

PVigi’s Solution
PVigi stepped in to conduct a Comprehensive Benefit-Risk Assessment for the client’s product. Our approach included:

Data Collection and Analysis

Benefit-Risk Framework

Stakeholder Engagement

Regulatory Submission

Outcome
Positive Regulatory Outcome: The benefit-risk assessment demonstrated that the product’s therapeutic benefits outweighed its risks, leading to continued market authorization.

Enhanced Safety Profile: The client implemented additional risk minimization measures, further improving the product’s safety profile.

Stakeholder Confidence: Clear communication of the benefit-risk profile reassured healthcare professionals and patients, maintaining trust in the product.

Proactive Approach: The client adopted a proactive approach to benefit-risk management, setting a standard for future products.