Module 12 Presentations

Impact of non-standardised data

Industry impact:

Patient impact:

! Lack of data re-use

! Cross Border Healthcare (prescriptions)

! Inefficient regulatory submissions

! Pharmacovigilance

! Time lag for updates to be reflected in patient leaflets

! Drug Shortages

And more …

And more …

FDA/GIDWG example: fatalities caused by substandard pediatric liquid dosage medicines

The Organisation for Professionals in Regulatory Affairs