Significance of Risk management plan
A risk management plan, according to Science, encompasses a range of strategies developed to minimize risks associated with pharmaceuticals. These plans are essential for monitoring potential adverse effects, guiding assessments from Periodic Safety Update Reports (PSURs), and reducing drug-related issues during clinical trials. They ensure drug benefits outweigh risks and comply with regulatory requirements from the USFDA and EMA. Ultimately, risk management plans help maintain a positive risk-benefit profile for medications, especially in the context of quality by design and pharmaceutical quality systems.
Synonyms: Contingency planning
The below excerpts are indicatory and do represent direct quotations or translations. It is your responsibility to fact check each reference.
The concept of Risk management plan in scientific sources
The Risk Management Plan is a strategic framework designed to minimize drug-related issues, comply with regulatory requirements from USFDA and EMA, and evaluate risks during clinical trials to enhance patient safety in drug therapies.
From: The Malaysian Journal of Medical Sciences
(1) A strategy to identify and assess potential disaster risks, and to implement measures to reduce these risks.[1]