Using risk-based approaches across the product lifecycle to simplify, standardise & enhance the...
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Transcript of Using risk-based approaches across the product lifecycle to simplify, standardise & enhance the...
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100%
Manufacturersubmitted -Expedited
reports
Manufacturersubmitted -
Periodicreports
Direct reportsby HCPs &
Patients
Incompletereports
Completereports
2% 3% 1%
11%
15%
5%
32%
4% 6%
5%
9%
12%
12%
In pregnancy
In this age group
In women
Because of new non-clinical data raises
safety concerns
Because the class of meds has just come under scrutiny
due to a competitor safety issue
Related to the abuse of this medicine
In real world use
In this ethnic group
In a new disease area
Because the product has just gone OTC
.
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• ‘Informative Reports have
greatest impact’
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