Benefit risk management verifies that benefits of a medication continue to outweigh the risks ensuring patient safety with medicinal therapies.
Benefit risk management encompasses assessment of safety of therapies across all phases of their life cycle through cross functional collaboration of different pharmacovigilance and regulatory teams.
The RMP showcases current knowledge about safety and efficacy of a therapy, and provides vital information on plans such as studies, to gather knowledge and recommend measures to mitigate or prevent associated risks.
REMS is a safety program required by US FDA for therapies with serious risks to ensure the benefits of the medication continue to outweigh the risks.
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