The European Medicines Agency (EMA) is hosting an online event to launch the revised guideline on good pharmacovigilance practices (GVP) Module XVI and its Addendum II.

The event will provide an overview of how stakeholder comments from the public consultation on these documents have been addressed.

This will be followed by a questions and answers session for answering audience questions.

Presentations are given by speakers from the Pharmacovigilance Risk Assessment Committee (PRAC) and EMA.

The event is for participants from the pharmaceutical industry, EMA’s stakeholder network of eligible organisations, non-EU regulators and international partners, as well as interested researchers.

Please note that the meeting will be held virtually only, and the session will be recorded for registered participants who could not attend and EMA in-house training events.