Module 12 2019

From Documents into Data

Optimization of variations possible, but a large % of variations affect the SmPC and/or patient leaflet.

• Looking for a (technical) solution of structured product labeling →

o More flexible for updates/variations

o Quicker information to patients and health care professionals

o Patient health record

• Reporting of Adverse effects by mobile use

• Share available information across disciplines → Shortage, FMD, etc

The Organisation for Professionals in Regulatory Affairs