Aggregate Safety Reporting & PSUR

1
Periodic Adverse Experience Reports (PADERs) in the United States
4 Minutes

US Periodic Reports or PADERs

2
US PADERs
6 questions

1
EURD List – European Union Reference Dates
5 minutes

The EURD list is a comprehensive list of active substances and combinations of active substances contained in medicinal products subject to different marketing authorisations, together with the corresponding EU reference dates, frequencies for submission of PSURs and related data lock points. This provides information on whether a PSUR needs to be submitted for a particular product, in the European Union.

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Enrolled: 6 students
Duration: 60 Minutes
Lectures: 2
Level: Intermediate

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