Current Edition

Innovations in the PASS Concept

Opening the Door to Real-world Data
The role of data collected during post-marketing surveillance has
recently been widely recognised as being of great value in terms
of providing real-world evidences, as long as the credibility,
quality and transparency of data is maintained. In parallel with the
dynamic increase of requirements and challenges concerning Post-
Authorisation Safety Studies planning, conduct and assessment,
the European Medicines Agency offers flexibility and firm scientific
assistance to marketing authorisation holders. Magdalena
Matusiak, MPharm, Clinical Development Manager at KCR,
focuses on the PASS concept.