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 →

• More flexible for updates/variations

• Quicker information to patients and health care professionals

Patient health record

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• Reporting of Adverse effects by mobile use

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

The Organisation for Professionals in Regulatory Affairs