Literature screening: manual or AI-assisted?
Where AI already provides reliable support in the pharmacovigilance workflow today — and where expert judgement remains irreplaceable.
Articles
What really goes wrong in practice.
Short articles on the points where pharmacovigilance systems break down in day-to-day work — and what an inspection asks about them.
Signal detection: person or process?
Why inspection readiness must not depend on individual people — and the three elements that make up a robust signal process.
Five myths about adverse reaction reporting
“I don’t need to report that.” — a sentence that can prove costly in pharmacovigilance. Five persistent assumptions and what actually applies.
Outsource pharmacovigilance or build it in-house?
The question arises in almost every company with its first marketing authorisation. Four points that should be clarified beforehand.
Keeping track of PSUR deadlines
A missed PSUR deadline costs more than nerves. How data lock points, the EURD list and submission fit together — and where planning typically breaks down.