What does AESI mean in VACCINE
An Adverse Event of Special Interest (AESI) is an event that has been identified as being associated with greater potential for serious harm than other adverse events, and requires additional monitoring and reporting to regulatory authorities. AESIs are selected based on their safety profile, seriousness or unexpectedness, as well as the potential impact of their occurrence on public health or patient safety.
AESI meaning in Vaccine in Medical
AESI mostly used in an acronym Vaccine in Category Medical that means Adverse Event of Special Interest
Shorthand: AESI,
Full Form: Adverse Event of Special Interest
For more information of "Adverse Event of Special Interest", see the section below.
Essential Questions and Answers on Adverse Event of Special Interest in "MEDICAL»VACCINE"
What is an Adverse Event of Special Interest?
An Adverse Event of Special Interest (AESI) is an event that has been identified as having a greater potential for serious harm than other adverse events and requiring additional monitoring and reporting to regulatory authorities.
How are Adverse Events of Special Interest selected?
AESIs are selected based on their safety profile, seriousness or unexpectedness, as well as the potential impact of their occurrence on public health or patient safety.
Who is responsible for selecting Adverse Events of Special Interest?
Generally, regulatory agencies such as the US Food & Drug Administration (FDA) or the European Medicines Agency (EMA) are responsible for selecting AESIs.
Are there any requirements regarding reporting of Adverse Events of Special Interest?
Yes, companies must report all AESIs promptly to the relevant regulatory authority in order to ensure patient safety.
What happens if an Adverse Event of Special Interest is not reported?
If a company fails to report an AESI in a timely manner, they may be subject to penalties from the relevant regulatory authority.
Final Words:
An Adverse Event of Special Interest (AESI) represents an important consideration in drug development and manufacturing processes due its potential for serious harm and subsequent requirements for prompt notification to relevant regulators. Understanding what constitutes an AESI and managing them effectively can help minimize risk to patients from unsafe drugs and medical devices.
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