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Recorded Webinar
Risk assessment: approaches to avoid medication errors and ensure dose accuracy within a EU/US regulatory compliance framework
timelapse 60 mins with 10-15 mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
The pharmaceutical industry and regulators can assess and manage risk using recognized risk management tools and/ or internal procedures such as Failure Mode Effect Analysis (FMEA), Human Factors Testing (FDA) and User Testing (EMA).
According to the Institute of Medicine (IOM) of the National Academies, there are more than 7,000 deaths a year due to medication errors. Mistakes can occur anywhere in the medication-use system, from prescribing to administering a drug in a variety of settings (hospitals, outpatient clinics, nursing homes, home care, etc.). But how can they be avoided? Examples will be given anticipating and reducing potential risks, and implementing risk minimization plans.
Addressed will be practical examples of :
- Risk-based approaches such as Assessment of Failure Mode Effect Analysis
- Issues of accurate and safe dose delivery of injection products
- Avoiding medication errors of products of different dosage forms with and without devices
- Best practices in labelling to ensure accuracy of administration and avoiding side effects for optimal tolerance
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