risk management plan in pharmacovigilance
A Risk Management Plan (RMP) in pharmacovigilance is a critical document designed to ensure the safe and effective use of medicinal products. It outlines strategies to identify, evaluate, and mitigate risks associated with a drug throughout its lifecycle. The RMP includes details about potential safety concerns, pharmacovigilance activities, and risk minimization measures. Regulatory agencies, such as the FDA and EMA, require pharmaceutical companies to submit RMPs for new drugs or biologics. This plan ensures continuous monitoring of adverse events, enhances patient safety, and helps healthcare professionals make informed decisions about the medication.