Risk Benefit Optimization
Accelerated approvals and regulatory pressure make it crucial to demonstrate drug safety, effectiveness, and post-approval utilization patterns, under real-world conditions
The European Medicines Agency (EMA) and Food and Drug Administration (FDA) require a Risk Evaluation and Mitigation Strategy (REMS) and Risk Management Plans (RMP) to ensure that the drug's benefits outweigh patient risks, and that risks are minimized as much as possible.
What do you get with Risk Benefit Optimization?
Over 1500 scientific and peer-reviewed articles to further understanding in health research.