Pharmacovigilance and Drug Safety

Pharmacovigilance and Risk Management

The guideline on GVP was a key deliverable of the 2010 pharmacovigilance legislation.

Each chapter and revisions are developed by a team consisting of experts from EMA and from EU Member States.

The guideline on GVP is divided into chapters that fall into two categories:

modules covering major pharmacovigilance processes;

.product- or population-specific considerations.

.Modules covering major pharmacovigilance processes