expedited
VigiServe Foundation > expedited
Rolling Review – The New Normal?
12
Dec
In general, the overall process of product identification to authorization, may take at least 5-10 years. However, in case of pandemics, public health emergencies, or certain other cases, the overall timeline may need to get shortened. One such action, that supports this, is the rolling review. A rolling review is a regulatory tool, that the […]
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emergency ,
expedited ,
pharmacovigilance ,
public health ,
review ,
rolling ,
safety ,
vaccine ,
Reporting Timeline Asymmetry in Pharmacovigilance
23
Nov
Whenever we think about expedited reporting of adverse event reports, the first number that comes to our mind is 15. This is mainly because ‘most’ of the regulatory agencies require serious reports to be submitted within 15 Calendar Days, and non-serious reports within 90 Calendar Days. The term ‘most’ is the appropriate term as there […]