Blogs
From our experts
Practical notes on pharmacovigilance, clinical research, regulatory affairs and pharma software, written by the people who do the work.
Pharmacovigilance
What a QPPV does, and why every marketing authorization holder needs one
The Qualified Person for Pharmacovigilance is the one person who answers for the safety system behind your products. Here is what the role covers in practice.
QualityFive steps to get ready for a pharmacovigilance inspection
Inspections go well when the system is in order long before the notice arrives. These five steps cover what inspectors usually want to see first.
SoftwareICH E2B (R3) in plain language
E2B (R3) is the international standard for sending safety reports electronically. This is what it means for the way your team records and submits cases.