A review of the EU Guidance on the SmPC considering important changes in the Guidance, as well as discussion on the Clinical, Pre-clinical and Pharmaceutical Issues in creating or amending the SmPC (with special emphasis on the anticipated problem areas)
The other important issue regarding the SmPC is EU harmonisation, and this meeting will consider procedures for harmonisation emphasising articles 29 and 30, and outline experience to date from both a regulatory and industry point of view.
TOPICS TO BE COVERED AT DURING THIS MEETING:
- EU SmPC: Significant and interesting changes in the Guidance
- Industry view of changes to the SmPC guidance
- EU Harmonisation of the SmPC: articles 29 and 30 harmonisation
- Industry view of harmonisation
- The SmPC and the Package Leaflet
