Spring Intro 2023

16/02/2023

Safety variations can be triggered by a variety of sources

• Clinical Study report readout • Routine pharmacovigilance e.g. safety signal identified

Internal

Company Activity

Study readout

Company position (CDS)

EU PI

Lit. review Safety signal

PhV activities

CDS - Core Data Sheet

19

• Clinical Study report readout • Routine pharmacovigilance e.g. safety signal identified • Health authority mandated e.g. class labelling Safety variations can be triggered by a variety of sources

Internal

External

Company

Study readout

EMA/ NCA

PhV activities

Company position (CDS)

EU PI

Class labelling

Safety signal

Lit. review

20