Prioritise patient safety and regulator compliance with benefit risk management solutions. Navigate complex healthcare landscapes, decision-making and successful outcomes.
Benefit risk management
Benefit risk management is the process used to safeguard the use of medicines. The point of this is to ensure that the benefits of a medicinal product outweigh the risks associated with a specific condition. Results are showcased as favourable and unfavourable for the specific treatment.
A risk management plan (RMP) is a document that showcases the knowledge about the safety and efficacy of a medicinal product. This provides vital information on plans for circumstances, such as studies, to gather more knowledge about the safety and efficacy of the medicine.
A risk evaluation and migration strategy (REMS) is a programme designed for drug safety. This is used by the U.S. Food and Drug Administration (FDA), where they can require certain medications with serious safety issues, thus helping to ensure the benefits of the medication outweigh the risks.