The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) are increasingly proactive in ensuring that the benefit-risk balance of a medicine is positive throughout the entire life cycle of a medicine for all patients in the target population. Both the EMA and the FDA are making transparency a priority; proactively seeking the viewpoints of patients and other stakeholders; encouraging advances in safety science; asking for acknowledgment of the populations excluded from clinical trials; striving for optimum safety integration into the healthcare system; and assessing a medication’s value by examining its benefit-risk trade-offs in populations and sub-populations.

This shift in approach and demand for more real-world data provides challenges and opportunities in addressing these evolving regulatory requirements and other stakeholder needs. With the right approach and the right partner, you can develop innovative benefit-risk programs that meet safety standards and deliver cost-effective, value-added tools for monitoring and measuring safety and effectiveness – and for proactively managing the risks of your products.