Aggregate Reporting

Which Pharmacovigilance Job Role is High demanding and gives High Salary packages?

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Hello Pharmacovigilance Professionals and Pharmacovigilance Aspirants, If you are a fresher or just started your career in Pharmacovigilance (PV) then you must have a lot of queries regarding what are different roles in PV jobs? Which Pharmacovigilance Job Role is High demanding? Which Pharmacovigilance Job Role provides High Salary packages? Pharmacovigilance Job  First of all, lets see what are the overall …

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Basics of DSUR (Development Safety Update Report)

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The Development safety update report (DSUR) is pre-marketing periodic report which covers safety information of drugs, biological, vaccines and combo products under development (including marketed drugs that are under further study) among the ICH regions.   Development Safety Update Report (DSUR) DIBD (Development International Birth Date) DIBD is the date of first approval (or authorisation) …

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Understanding Basics of PADER (Periodic Adverse Drug Experience Report)

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Dear PV Professionals and PV Aspirants, Today we will see some basic facts about PADER (Periodic Adverse Drug Experience Report). What is PADER? A PADER is a type of aggregate safety report required to be submitted by a sponsor or marketing authorization holder (MAH) to the US Food and Drug Administration (FDA) after obtaining marketing authorization approval. PADER …

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What are Aggregate Reports in Pharmacovigilance?

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Hi All, In this article we will see What are Aggregate Reports in Pharmacovigilance? Aggregate report is the process that reviews the cumulative safety information from a wide range of sources, on a periodic basis and submits the findings to regulators worldwide. The aggregate report examines and summarizes all existing safety experience with a medicinal product. …

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