Managing drug safety is core to enterprise risk management. Life sciences companies must manage risks with providing needed drugs to patients and decrease safety risks and regulatory non-compliance. Designing and operating a drug safety risk management program poses challenges that can threaten patient safety and regulatory compliance. A tested drug safety risk management program lets patients access needed drugs and makes sure manufacturers are in compliance.
Drugs with normal risks are generally addressed with labeling alone, but drugs with unusual risks need a Risk Evaluation and Mitigation Strategy (REMS) management program to monitor effective drugs that have serious risks. For drugs that have high potential for serious side effects or abuse, the Food and Drug Administration (FDA) requires a Risk Minimization Action Plan (RiskMAP) to minimize drug risks while preserving benefits.
BearingPoint provides life sciences companies with risk planning, which can monitor drug safety. We have extensive knowledge of risk management program delivery and operational design and can help manufacturers integrate data needed to accurately and easily report to FDA and monitor compliance. Our services for development and operation of drug safety risk management programs include:
- Design, development, and operation of FDA-mandated REMSes and RiskMAPs
- Program and vendor management of risk management programs
- Assessment of vendors’ abilities to deliver risk management services
- Drug safety and regulatory design
Integrated data warehousing, data collection and reporting for risk management programs
Overall, we have experience supporting large, complex risk management programs and developing drug safety surveillance tools to decrease risks.
To learn more about the drug safety risk management challenges life sciences companies face today, download our white paper on creating a comprehensive drug safety risk management strategy.