A Risk Management Plan systematically outlines Lilly's pharmacovigilance process for a medication, describing the ongoing activities designed to identify, characterize, minimize, and communicate product safety information.
Lilly develops a Risk Management Plan (RMP) for every medication. Sometimes regulators require this RMP be submitted for regulatory approval as part of its application process.
The RMP outlines the specific plan to further understand the safety profile of that product. In addition it will outline when applicable how Lilly plans to go about minimizing risks (for example, training for physicians that will teach them what specific actions should be taken to lessen certain risks) that may be associated with the medication.
After a drug receives approval and is made available to patients, the Risk Management Plan continues to be updated as additional information becomes available that impacts the safety profile or benefit/risk balance of the product. Updates are submitted to the regulatory authorities.
What are the elements of a Risk Management Plan?
- Identifies and characterizes the safety profile of a product on the basis of non-clinical, clinical and post-marketing data
- Outlines how the important known or potential risks will be monitored for further evaluation (e.g. by conducting additional studies, monitoring of existing databases)
- Specifies how the risk will be mitigated through a risk minimization plan if necessary. This plan describes a set of activities for minimizing the important known or potential risks of a product in order to optimize the benefit/risk balance.