Search results
Results from the WOW.Com Content Network
Risk Evaluation and Mitigation Strategies (REMS) is a program of the US Food and Drug Administration for the monitoring of medications with a high potential for serious adverse effects. REMS applies only to specific prescription drugs, but can apply to brand-name or generic drugs. [1] The REMS program was formalized in 2007.
The risks described in a risk management plan fall into one of three categories: identified risks, potential risks, and unknown risks. Also described within a risk management plan are the measures that the Market Authorization Holder, usually a pharmaceutical company, will undertake to minimize the risks associated with the use of the drug.
Risk assessment determines possible mishaps, their likelihood and consequences, and the tolerances for such events. [1] [2] The results of this process may be expressed in a quantitative or qualitative fashion. Risk assessment is an inherent part of a broader risk management strategy to help reduce any potential risk-related consequences. [1] [3]
Together with risk assessment and risk management, risk communication aims to reduce foodborne illnesses. Food safety risk communication is an obligatory activity for food safety authorities [73] in countries, which adopted the Agreement on the Application of Sanitary and Phytosanitary Measures. Risk communication also exists on a smaller scale.
As part of a risk management system, decisions on the extent of validation and data integrity controls should be based on a justified and documented risk assessment of the computerised system." The subsequent validation or verification of computer systems targets only the "GxP critical" requirements of computer systems. Evidence (e.g. screen ...
When conducting a workplace hazard assessment, occupational hygienists may find it useful to start with occupational exposure banding to identify potential hazards and exposure ranges, before moving on to control banding. Together, these tools will aid the health & safety professional in selecting the appropriate risk mitigation strategies.
President Donald Trump’s pick to lead the US Food and Drug Administration told senators in a tense confirmation hearing Thursday that, if confirmed as FDA commissioner, he plans to evaluate ...
Clinical quality management systems (CQMS) are systems used in the life sciences sector (primarily in the pharmaceutical, biologics and medical device industries) designed to manage quality management best practices throughout clinical research and clinical study management. A CQMS system is designed to manage all of the documents, activities ...