Pharmacovigilance writing: monitoring and enhancing patients’ safety

This webinar addresses participants with no or little experience in pharmacovigilance (PV) writing. The presentation will provide an overview of the basic concepts involved in PV writing, such as the life cycle of the medicinal product, benefit-risk balance, and safety concerns.

There will be a brief introduction to the main PV documents required from clinical development up to marketing authorisation renewal, with focus on how these documents reflect specific PV activities to monitor and enhance patients’ safety. Interactions and synergies between PV documents and other clinical or labelling documents will also be briefly shown. Furthermore, an overview of the writing activities beyond submission will be provided.

The webinar will indicate which EMWA workshops offer intensive training on the various topics presented.

Presented by Tiziana von Bruchhausen, you can register for this webinar on Thursday, September 19 from 2:00 PM - 4:00 PM CEST here.