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 risks.
Lilly includes a Risk Management Plan for every medication as part of its New Drug Application that is submitted for regulatory approval
The Risk Management Plan outlines the specific risk assessment and risk minimization activities (if needed) associated with the medication.
The primary purpose of a Risk Management Plan is to proactively and systematically describe a set of specific safety monitoring and evaluation activities designed to identify, characterize, and minimize and/or prevent risks that may occur with the use of a particular 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 the important established or potential risks on the basis of non-clinical, clinical and post-marketing data
Outlines how the 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. This plan describes a set of activities for minimizing the identified or potential risks of a product in order to optimize the benefit/risk balance.