Understanding Basics of PADER (Periodic Adverse Drug Experience Report)
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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